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About the role
Key responsibilities & impact- Lead clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement.
- Monitor clinical trial sites for adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
- Conduct site visits to assess site performance, resolve issues, and support successful trial execution.
- Collaborate with cross-functional teams to ensure timely and accurate data collection and reporting.
- Provide training and guidance to site staff and other CRAs.
- Build and maintain effective relationships with site personnel and stakeholders to facilitate smooth trial operations.
Requirements
What you’ll need- A bachelor’s degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
- 3-5 years of CRA monitoring experience in CRO/pharma environments
- Strong preference for at least 1 year of medical device monitoring experience; complex pharma monitoring experience will be considered.
- In-depth knowledge of FDA regulations and ICH/GCP guidelines.
- Strong problem-solving skills to mitigate risks and identify issues at sites and implement effective solutions promptly.
- Strong interpersonal skills to establish and maintain effective working relationships with site personnel, investigators, and internal teams.
- Exceptional verbal and written communication skills, with the ability to convey complex information clearly and concisely.
- Ability to tailor communication style to the needs and preferences of different stakeholders, fostering a collaborative environment.
- Ability to work independently and manage multiple priorities in a dynamic environment.
- A well-executed plan for communication with the study teams and sites.
- Well-versed in clinical trial management; rigorous, detail-oriented, and precise in reports.
- Willingness to travel as required (approximately 60%).
- Legal right to work in the country where the role is based.
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways