Senior Study Start Up Specialist
il y a 4 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 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 various initiatives and may assist with site selection.
- 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.
- 2 years' experience in a similar position in either CRO or Pharma.
- Excellent collaboration, interpersonal, verbal, and written communication skills.
- Proficient in written and spoken English language required; fluency in French is essential.
- Ability to prioritize and manage multiple tasks with conflicting deadlines.
- Good knowledge of international guidelines ICH-GCP and relevant local regulations.
- Excellent understanding of Clinical Study Management and study start-up.
- Bachelor's degree in a related discipline, preferably in life science, or equivalent qualification.
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