Study Start-Up Manager
il y a 3 semaines
About the Role:
Parexel is seeking a highly skilled Study Start-Up Manager 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 feasibility assessment of potential studies and participate 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 different initiatives and may support site selection process by identifying and assessing potential sites/investigators.
- Ensure timely collection/uploading of essential documents into the eTMF and support Quality Control (QC) checks.
- Accountable for study start-up and regulatory maintenance, including submission of proper application/documents to Regulatory Authorities and/or IEC/IRB.
Requirements:
- 2 years' experience in a similar position in either CRO or Pharma.
- Good 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, with ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials.
Education:
- Bachelor's degree in a related discipline, preferably in life science, or equivalent qualification.
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