Study Start-Up Manager
il y a 2 jours
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 assessment of clinical and operational feasibility of potential studies to ensure high-quality results.
- Provide regular updates to line managers on study and planned study milestones/key issues during the start-up period.
- Support study management and monitoring in various initiatives, including local, regional, or global projects.
- May assist in site selection by identifying and assessing potential sites/investigators.
- Accountable for study start-up and regulatory maintenance, including collection, preparation, review, and tracking of documents for the application process.
- Responsible for submitting proper applications/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 timely resolution.
- May be accountable for preparing, reviewing, and negotiating 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, as well as planning applicable local drug activities.
- 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 a related discipline, preferably in life science, or equivalent qualification.
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