13 R D jobs in Australia
Senior Specialist, R&D Lab Operations

Posted 4 days ago
Job Viewed
Job Description
**Job Description**
**About the Role**
The **Senior Specialist, R&D Lab Operations** is part of the R&D Lab Operations team, reports to the Head of Lab Operations, and is responsible for supporting and coordinating the oversight of critical lab operations, including buffer/media preparation, equipment preparation and temperature-controlled environments such as cold rooms, freezers and incubators. This role ensures the smooth execution of day-to-day laboratory infrastructure processes delivered by external partners (e.g., ISS under the IFM program), aligning them with Takeda's internal compliance, quality, and safety standards.
**How you will contribute:**
+ Plan and oversee buffer/media preparation workflows across R&D functions, ensuring IFM partners execute work effectively while maintaining operational continuity and compliance.
+ Oversee lab infrastructure operations, ensuring equipment is maintained and calibrated. Ensure PCS and CIP systems are adequately serviced by coordinating with technical specialists.
+ Monitor and ensure optimal performance of cold rooms, freezers, and incubators, focusing on temperature control and calibration.
+ Develop, maintain, and ensure adherence to SOPs aligned with internal and external standards.
+ Enforce safety protocols for hazardous chemical handling and ensure legal compliance.
+ Conduct inspections and validate service delivery by IFM partners.
+ Manage and optimize KPIs to ensure performance, drive continuous improvement, and minimize inefficiencies.
**Skills and qualifications:**
+ HTL diploma in biotechnology or related field with 7+ years of experience, or a Bachelor's degree (or higher) with 5+ years of relevant experience.
+ Proven expertise in lab operations, infrastructure management, EHS compliance, and SOP development.
+ Strong understanding of automated systems, particularly PCS, and the ability to effectively coordinate with technical support to address system maintenance and issues.
+ Demonstrated ability to lead cross-functional teams and manage diverse stakeholders.
+ Fluent in German and business proficiency in English, with excellent written and verbal communication skills.
+ Strategic mindset with strong problem-solving and prioritization skills, while remaining collaborative, proactive, and adaptable in a global, fast-paced environment.
+ Familiarity with process automation tools such as Power Platform is an advantage
**What we offer you:**
A competitive remuneration package with a minimum salary of 4.270,14 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary is higher and depends on your professional experience and qualifications.
+ Family-friendly company environment; support with parental leave, dad month, Bilingual company kindergarten
+ depending on the position / department
+ Commuting allowance or parking space (tax applicable)
+ Comprehensive training programs
+ In-house job rotation program
+ In-house Canteen with discounts or meal vouchers
+ Works council (events, festivals, shopping vouchers, etc.)
+ Employee Referral Program
+ Employee Recognition Program
+ Takeda Resource Groups
+ Medical checkups
+ Free vaccination program
+ Fitness Center in I67
+ Employee discounts
+ Employee Stock Purchase Plan
+ Group accident insurance
**More About Us:**
Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-changing treatments for patients are deeply rooted in over 230 years of distinguished history in Japan.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
**Make History, Change Futures.**
For over 240 years, Takeda's propensity to evolve has driven the next generation of innovation. Today, the organization spans the globe-colleagues across business units and functions face challenges head-on to deliver on our vision. The omnipresent patient focus instills pride in personal contributions.
**How we will support you:**
Takeda is proud of its commitment to create a diverse workforce and to provide equal employment opportunities to all employees and applicants for employment without regard to ethnicity, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law. If you are living with disabilities, chronic illness, or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process.
**Locations**
AUT - Wien - DC Tower
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
Executive Director, R&D Advanced Analytics, Automation, and AI Lead
Posted today
Job Viewed
Job Description
The Position:
The R&D Advanced Analytics, Automation, and AI Lead is responsible for executing the R&D digital acceleration roadmap, with a primary focus on delivering business value through advanced and emerging technologies. In close collaboration with I&T, this role oversees the design, development, and deployment of analytics, automation, and AI/ML solutions across the R&D value chain. The leader partners with RDLT, TES LT, I&T, and external innovation ecosystems to identify and apply disruptive technologies that enable measurable transformation. Acting as a strategic bridge between R&D and I&T, this role ensures digital acceleration initiatives are technically robust, operationally impactful, and fully aligned with enterprise architecture and capabilities.
Responsibilities:
- Lead the development and execution of the R&D digital acceleration roadmap focused on automation, AI, and advanced analytics
- Identify disruptive technologies and use cases (e.g., generative AI, intelligent automation, simulation, digital twins)
- Partner with business stakeholders to develop scalable, production-ready digital solutions
- Lead agile teams to develop models, tools, and platforms aligned with R&D needs
- Drive rapid experimentation and innovation, ensuring feasibility, compliance, and user adoption
- Establish metrics to measure the impact of digital interventions on cycle times, quality, and outcomes
- Oversee partnerships with AI/ML vendors, academic collaborators, and industry consortia
- Build internal capabilities and talent pipelines for digital and analytics functions
- Ensure that all AI, automation, and advanced analytics solutions are implemented in a compliant manner, supporting readiness for regulatory audits and inspections involving emerging technologies
- Provide thought leadership in AI, including the development and implementation of AI governance frameworks, ethical AI practices, and active engagement with industry consortia such as Pistoia Alliance, CIOMS, TransCelerate, and other relevant forums to shape standards and best practices
Education & Requirements:
- Master’s or PhD in Data Science, Engineering, Computer Science, or related fields
- 15+ years of experience in digital leadership or advanced analytics/AI roles within R&D-driven pharmaceutical industry
- Deep knowledge of life sciences and experience applying AI/ML and automation in scientific or regulatory domains
- Demonstrated ability to deliver AI-enabled tools in regulated environments
- Strong cross-functional collaboration and change leadership skills
- Expertise in digital product lifecycle, from experimentation to scale
- Experience supporting regulatory audits and inspections involving emerging technologies, including AI and automation, in a GxP or highly regulated environment
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around usAt CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!Clinical Research Associate 2

Posted 10 days ago
Job Viewed
Job Description
Please note as part of the assessment you will be asked for complete a short video screening interview.
Essential Functions:
+ Engage in Site Visits: From selection to close-out, your visits will be pivotal in ensuring the success of our studies.
+ Recruitment Strategies: Develop and implement innovative plans to recruit study subjects, making a tangible impact on project outcomes
+ Empower Sites with Knowledge: Provide essential training and maintain robust communication channels to keep sites aligned and motivated.
+ Champion Quality and Integrity: Evaluate and enhance site practices, ensuring adherence to protocols and regulations.
+ Drive Study Progress: Monitor every aspect of the study, from regulatory submissions to data query resolutions, ensuring seamless execution.
+ Master Documentation: Keep meticulous records and ensure all site documents are perfectly maintained.
+ Collaborate and Innovate: Work closely with a passionate team to support project execution and drive success.
+ Manage Finances with Precision: Oversee site financials and ensure timely invoice retrieval.
**What You Bring**
+ A degree in life sciences or healthcare (or equivalent experience).
+ 18 months minimum of on-site monitoring experience to be considered ideally oncology
+ Deep knowledge of GCP, ICH, and clinical trial operations.
+ Tech-savvy with Microsoft Office and mobile tools (iPhone/iPad).
+ A proactive mindset, strong communication skills, and a passion for excellence.
**Why Join Us?**
+ Work ondiverse, global studiesacross multiple therapeutic areas.
+ Be part of asupportive, innovative teamthat values your growth.
+ Enjoyflexible work arrangements, travel opportunities, and career develop
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Senior Clinical Research Associate

Posted 10 days ago
Job Viewed
Job Description
When you join IQVIA AUSTRALIA as a sponsor-dedicated CRA, you'll enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our customers. With access to world-class training and mentoring, you'll have the opportunity to put your passions to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.
You must have a minimum of 4 years Independent on-site monitoring experience to be considered for this role. We regret to inform you that we can not consider sponsorship for this role at this stage so only candidates with full work rights will be contacted.
You will be asked to complete a short video screening as part of the interview process.
Sydney and Melbourne are preferred locations for this role.
**Essential Functions:**
+ Engage in Site Visits: From selection to close-out, your visits will be pivotal in ensuring the success of our studies.
+ Recruitment Strategies: Develop and implement innovative plans to recruit study subjects, making a tangible impact on project outcomes
+ Empower Sites with Knowledge: Provide essential training and maintain robust communication channels to keep sites aligned and motivated.
+ Champion Quality and Integrity: Evaluate and enhance site practices, ensuring adherence to protocols and regulations.
+ Drive Study Progress: Monitor every aspect of the study, from regulatory submissions to data query resolutions, ensuring seamless execution.
+ Master Documentation: Keep meticulous records and ensure all site documents are perfectly maintained.
+ Collaborate and Innovate: Work closely with a passionate team to support project execution and drive success.
+ Manage Finances with Precision: Oversee site financials and ensure timely invoice retrieval.
**Qualifications:**
+ Educational Excellence: Bachelor's degree in a scientific or healthcare discipline preferred.
+ Experience Matters: At least 4 years of on-site monitoring experience (across Australia), with preference for Oncology trial management exposure.
+ Regulatory Savvy: Strong knowledge of GCP and ICH guidelines.
+ Tech-Savvy: Proficiency in Microsoft Office and relevant technology.
+ Communication Pro: Excellent written and verbal skills.
+ Organized and Analytical: Strong organizational and problem-solving abilities.
+ Time and Financial Management: Effective in managing time and finances.
+ Team Player: Ability to build and maintain strong relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Senior Clinical Research Associate

Posted 10 days ago
Job Viewed
Job Description
When you join IQVIA AUSTRALIA as a sponsor-dedicated CRA, you'll enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our customers. With access to world-class training and mentoring, you'll have the opportunity to put your passions to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.
You must have a minimum of 4 years Independent on-site monitoring experience to be considered for this role. We regret to inform you that we can not consider sponsorship for this role at this stage so only candidates with full work rights will be contacted.
You will be asked to complete a short video screening as part of the interview process.
Sydney and Melbourne are preferred locations for this role.
**Essential Functions:**
+ Engage in Site Visits: From selection to close-out, your visits will be pivotal in ensuring the success of our studies.
+ Recruitment Strategies: Develop and implement innovative plans to recruit study subjects, making a tangible impact on project outcomes
+ Empower Sites with Knowledge: Provide essential training and maintain robust communication channels to keep sites aligned and motivated.
+ Champion Quality and Integrity: Evaluate and enhance site practices, ensuring adherence to protocols and regulations.
+ Drive Study Progress: Monitor every aspect of the study, from regulatory submissions to data query resolutions, ensuring seamless execution.
+ Master Documentation: Keep meticulous records and ensure all site documents are perfectly maintained.
+ Collaborate and Innovate: Work closely with a passionate team to support project execution and drive success.
+ Manage Finances with Precision: Oversee site financials and ensure timely invoice retrieval.
**Qualifications:**
+ Educational Excellence: Bachelor's degree in a scientific or healthcare discipline preferred.
+ Experience Matters: At least 4 years of on-site monitoring experience (across Australia), with preference for Oncology trial management exposure.
+ Regulatory Savvy: Strong knowledge of GCP and ICH guidelines.
+ Tech-Savvy: Proficiency in Microsoft Office and relevant technology.
+ Communication Pro: Excellent written and verbal skills.
+ Organized and Analytical: Strong organizational and problem-solving abilities.
+ Time and Financial Management: Effective in managing time and finances.
+ Team Player: Ability to build and maintain strong relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Senior Clinical Research Associate

Posted 10 days ago
Job Viewed
Job Description
When you join IQVIA AUSTRALIA as a sponsor-dedicated CRA, you'll enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our customers. With access to world-class training and mentoring, you'll have the opportunity to put your passions to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.
You must have a minimum of 4 years Independent on-site monitoring experience to be considered for this role. We regret to inform you that we can not consider sponsorship for this role at this stage so only candidates with full work rights will be contacted.
You will be asked to complete a short video screening as part of the interview process.
Sydney and Melbourne are preferred locations for this role.
**Essential Functions:**
+ Engage in Site Visits: From selection to close-out, your visits will be pivotal in ensuring the success of our studies.
+ Recruitment Strategies: Develop and implement innovative plans to recruit study subjects, making a tangible impact on project outcomes
+ Empower Sites with Knowledge: Provide essential training and maintain robust communication channels to keep sites aligned and motivated.
+ Champion Quality and Integrity: Evaluate and enhance site practices, ensuring adherence to protocols and regulations.
+ Drive Study Progress: Monitor every aspect of the study, from regulatory submissions to data query resolutions, ensuring seamless execution.
+ Master Documentation: Keep meticulous records and ensure all site documents are perfectly maintained.
+ Collaborate and Innovate: Work closely with a passionate team to support project execution and drive success.
+ Manage Finances with Precision: Oversee site financials and ensure timely invoice retrieval.
**Qualifications:**
+ Educational Excellence: Bachelor's degree in a scientific or healthcare discipline preferred.
+ Experience Matters: At least 4 years of on-site monitoring experience (across Australia), with preference for Oncology trial management exposure.
+ Regulatory Savvy: Strong knowledge of GCP and ICH guidelines.
+ Tech-Savvy: Proficiency in Microsoft Office and relevant technology.
+ Communication Pro: Excellent written and verbal skills.
+ Organized and Analytical: Strong organizational and problem-solving abilities.
+ Time and Financial Management: Effective in managing time and finances.
+ Team Player: Ability to build and maintain strong relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Senior Clinical Research Associate

Posted 10 days ago
Job Viewed
Job Description
When you join IQVIA AUSTRALIA as a sponsor-dedicated CRA, you'll enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our customers. With access to world-class training and mentoring, you'll have the opportunity to put your passions to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.
You must have a minimum of 4 years Independent on-site monitoring experience to be considered for this role. We regret to inform you that we can not consider sponsorship for this role at this stage so only candidates with full work rights will be contacted.
You will be asked to complete a short video screening as part of the interview process.
Sydney and Melbourne are preferred locations for this role.
**Essential Functions:**
+ Engage in Site Visits: From selection to close-out, your visits will be pivotal in ensuring the success of our studies.
+ Recruitment Strategies: Develop and implement innovative plans to recruit study subjects, making a tangible impact on project outcomes
+ Empower Sites with Knowledge: Provide essential training and maintain robust communication channels to keep sites aligned and motivated.
+ Champion Quality and Integrity: Evaluate and enhance site practices, ensuring adherence to protocols and regulations.
+ Drive Study Progress: Monitor every aspect of the study, from regulatory submissions to data query resolutions, ensuring seamless execution.
+ Master Documentation: Keep meticulous records and ensure all site documents are perfectly maintained.
+ Collaborate and Innovate: Work closely with a passionate team to support project execution and drive success.
+ Manage Finances with Precision: Oversee site financials and ensure timely invoice retrieval.
**Qualifications:**
+ Educational Excellence: Bachelor's degree in a scientific or healthcare discipline preferred.
+ Experience Matters: At least 4 years of on-site monitoring experience (across Australia), with preference for Oncology trial management exposure.
+ Regulatory Savvy: Strong knowledge of GCP and ICH guidelines.
+ Tech-Savvy: Proficiency in Microsoft Office and relevant technology.
+ Communication Pro: Excellent written and verbal skills.
+ Organized and Analytical: Strong organizational and problem-solving abilities.
+ Time and Financial Management: Effective in managing time and finances.
+ Team Player: Ability to build and maintain strong relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
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Senior Clinical Research Associate

Posted 10 days ago
Job Viewed
Job Description
When you join IQVIA AUSTRALIA as a sponsor-dedicated CRA, you'll enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our customers. With access to world-class training and mentoring, you'll have the opportunity to put your passions to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.
You must have a minimum of 4 years Independent on-site monitoring experience to be considered for this role. We regret to inform you that we can not consider sponsorship for this role at this stage so only candidates with full work rights will be contacted.
You will be asked to complete a short video screening as part of the interview process.
Sydney and Melbourne are preferred locations for this role.
**Essential Functions:**
+ Engage in Site Visits: From selection to close-out, your visits will be pivotal in ensuring the success of our studies.
+ Recruitment Strategies: Develop and implement innovative plans to recruit study subjects, making a tangible impact on project outcomes
+ Empower Sites with Knowledge: Provide essential training and maintain robust communication channels to keep sites aligned and motivated.
+ Champion Quality and Integrity: Evaluate and enhance site practices, ensuring adherence to protocols and regulations.
+ Drive Study Progress: Monitor every aspect of the study, from regulatory submissions to data query resolutions, ensuring seamless execution.
+ Master Documentation: Keep meticulous records and ensure all site documents are perfectly maintained.
+ Collaborate and Innovate: Work closely with a passionate team to support project execution and drive success.
+ Manage Finances with Precision: Oversee site financials and ensure timely invoice retrieval.
**Qualifications:**
+ Educational Excellence: Bachelor's degree in a scientific or healthcare discipline preferred.
+ Experience Matters: At least 4 years of on-site monitoring experience (across Australia), with preference for Oncology trial management exposure.
+ Regulatory Savvy: Strong knowledge of GCP and ICH guidelines.
+ Tech-Savvy: Proficiency in Microsoft Office and relevant technology.
+ Communication Pro: Excellent written and verbal skills.
+ Organized and Analytical: Strong organizational and problem-solving abilities.
+ Time and Financial Management: Effective in managing time and finances.
+ Team Player: Ability to build and maintain strong relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Graduate Clinical Research Associate -Victoria
Posted 5 days ago
Job Viewed
Job Description
**A Day in the Life**
As we enter a new year, applications are now open for recent graduates with a degree in Nursing Biomedical or Health Science to join the Clinical Research Team. As part of this program, you will develop a breadth of experience across the healthcare continuum, working alongside a group of professionals where you will gain best in class training and mentorship at an individual and team level.
At Medtronic, no two days will be the same, in the role you will be able to work with many different teams, learn about breakthrough therapies and see the impact they have on patients. You will be involved in supporting the administrative and clinical trial execution needs of the studies that you work on and make an impact on the future medical needs of our patients. This is the team that works with the frontline technologies. This role will enable you to navigate through challenging scenarios, develop your leadership and resilience skills, as well as develop an eye for detail that will allow you to excel in this and future roles. You will gain insight in to various parts of the product life cycle and you will see first hand the impact you can make using advanced technologies.
**Responsibilities may include the following and other duties may be assigned:**
+ Provide support for the execution of Medtronic clinical trials program
+ Responsible for performing and supporting research for teams operating within the clinical research team
+ Assists with the development, monitoring, coordination, and implementation of non-technical projects as assigned.
+ Provides analysis, reporting and internal communication services with team members.
+ Develops knowledge of industry and organizational processes.
+ Exposure to clinical trials processes and execution
**Required Knowledge and Experience:**
+ Bachelor's Degree in Nursing, Biomedical or Health Sciences graduate with a thirst for knowledge and a keen interest in medical device
+ Being a proactive thinker and problem solver
+ Having a strong collaborative approach and an ability to work across different teams
+ Excellent communication skills
+ A willingness and enthusiasm to learn new concepts with a growth mindset
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position?
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting?is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
Senior Clinical Research Associate-FSP

Posted 10 days ago
Job Viewed
Job Description
**Maintenance (from initiation through close out):**
Act as PAREXEL's direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.
+ Build relationships with investigators and site staff.
+ Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
+ Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.
+ Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
+ Address/evaluate/resolve issues pending from the previous visit, if any.
+ Follow-up on and respond to appropriate site related questions.
+ Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.
+ Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
+ Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.
+ Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
+ Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
+ Conduct remote visits/contacts as requested/needed.
+ Generate visit/contact report.
+ Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.
+ Assess & manage test article/study supply including supply, accountability and destruction/return status.
+ Review & follow-up site payment status.
+ Follow-up on CRF data entry, query status, and SAEs.
+ Conduct on-site study-specific training (if applicable).
+ Perform site facilities assessments
+ Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution
**Overall Accountabilities from Site Identification to Close out:**
Ensure timely and accurate completion of project goals and update of applicable trial management systems.
+ Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.
+ Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.
+ Ensure that assigned sites are audit and inspection ready
+ Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
+ Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.
+ Show commitment and perform consistent high-quality work.
+ Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.
+ Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.
+ Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.
+ Provide input and feedback for Performance Development Conversation(s).
+ Proactively keep manager informed about work progress and any issues.
+ Develop expertise to become a subject matter expert.
+ Work in a self-driven capacity, with limited need for oversight.
+ Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)
**Skills:**
+ Sound problem solving skills.
+ Able to take initiative and work independently, and to proactively seek guidance when necessary.
+ Advance presentation skills.
+ Client focused approach to work.
+ Ability to interact professionally within a client organization.
+ Flexible attitude with respect to work assignments and new learning.
+ Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.
+ Willingness to work in a matrix environment and to value the importance of teamwork.
+ Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
+ Strong interpersonal, verbal, and written communication skills.
+ Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables and preserving patient safety.
+ Effective time management in order to meet study needs, team objectives, and department goals.
+ Developing ability to work across cultures.
+ Shows commitment to and performs consistently high-quality work.
+ Ability to successfully work in a ('virtual') team environment.
+ Consulting Skills
+ Great attention to detail.
+ Able to accommodate extensive travel time requirements, according to tasks allocation/phase of the study assigned.
+ Holds a driver's license where required.
**Knowledge and Experience:**
+ Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
**Education:**
+ Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.