Responsibilities
- Main Point of Contact for assigned protocols and link between Country Operations and clinical trial team
- Responsible for project management of the assigned studies: actively plans, drive and track execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out
- Review Monitoring Visits Reports and raise performance issues and training needs to CRA manager and/or functional vendor and internal management as needed
- Perform Quality control visits as required
- Lead local study teams to high performance: train in the protocol other local roles, closely collaborate with and supports CRAs as protocol guide and coordinate activities across the different local country roles ensuring a strong collaboration
- Responsible for crafting and executing a local risk management plan for assigned studies
- Ensure compliance with CTMS, eTMF and other key systems
- Raises as needed different challenges and issues
- Responsible for collaboration with functional outsourcing vendors, investigators, other external partners
- Country point of contact for programmatically outsourced trials
- Serve local business needs as applicable in his/her country (If delegated can sign contracts and run budgets)
- Collaborate internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies
- As a customer-facing role, this position will build business relationships and represent the company with investigators
- Share protocol-specific information and standard methodologies across countries\clusters
Education/Qualifications:
University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution