Job SummaryPerforms assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials.
Responsible for delivery with oversight from Line Manager in areas such as investigator site contracts, ethics and regulatory submissions, collection and review of essential documents for site initiation and activation.
Ensures local activities align with agreed timelines, budgets, and quality standards, and ensures efficient start-up process on assigned studies.Job Responsibilities- Act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees under supervision of Project Lead or Site Activation Manager.
- Accountable to Project Lead/Site Activation Manager and line manager for deliverables at the project level.
- Provide quality on deliverables at the country level, follow project requirements and applicable country rules with oversight from SSU Country Manager.
- Work within forecasted submissio...