Senior Clinical Trial Specialist
il y a 2 semaines
Parexel is seeking a highly skilled Senior Study Start-Up Specialist to join our team in France. As a key member of our single sponsor dedicated team, you will be responsible for managing and conducting start-up activities in compliance with client procedures, documents, local and international guidelines such as ICH-GCP and relevant regulations.
Key Responsibilities- Contribute to the assessment of clinical and operational feasibility of potential studies, ensuring high-quality results and active participation in Local Study Team (LST) meetings.
- Provide regular updates to Line Managers on study and planned study milestones/key issues during the start-up period.
- Support Study Management and Monitoring (SMM) in various initiatives, as agreed with SMM Line Management.
- May support site selection by identifying and assessing potential sites/investigators.
- Ensure timely collection and uploading of essential documents into the eTMF, in accordance with ICH-GCP, client SOPs, and local requirements.
- Accountable for study start-up and regulatory maintenance, including collection, preparation, review, and tracking of documents for the application process.
- Responsible for submission of proper application/documents to Regulatory Authorities and/or IEC/IRB during the start-up period.
- Update CTMS and other systems with data from study sites, as per required timelines during the start-up period.
- Follow up on outstanding actions with study sites during the start-up period to ensure resolution in a timely manner.
- May be accountable for preparation, review, and negotiation of contracts with investigational sites, serving as the primary point of contact for investigational sites to ensure contracts are fully executed.
- Assist in initial forecasting for budget, study materials, and drug supplies, planning applicable local drug activities (local purchase or reimbursement).
- 2 years' experience in a similar position in either CRO or Pharma.
- Excellent collaboration, interpersonal, verbal, and written communication skills.
- Excellent attention to detail and negotiation skills.
- Proficient in written and spoken English language required.
- Fluency in French is essential.
- Analytical and problem-solving skills.
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
- Demonstrative ability to prioritize and manage multiple tasks with conflicting deadlines.
- Good knowledge of international guidelines ICH-GCP as well as relevant local regulations, basic knowledge of GMP/GDP.
- Excellent understanding of Clinical Study Management and study start-up.
- Basic understanding of drug development process.
- Bachelor's degree in related discipline, preferably in life science, or equivalent qualification.
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