Job Description
Job Description:
Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA). Provide support and oversight to local vendors as applicable.
Executes and oversees clinical trial country submissions and approvals for assigned protocols. Interacts with EC and Regulatory Authority(RA) for assigned protocols.
Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
Oversees CTCs as applicable. Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
Works in partnership internally with GCTO CO, finance, regulatory affairs, PV, legal and regional operations, HQ functional areas and externally with vendors and sites, ECs and RA in submission and approval related interactions.
Contributes strongly to COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. Contributes to the development of local SOPs. Contributes to COM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required.
Qualifications:
Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.
Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the COM Led or manager.
Ability to lead a team of CTCs as applicable.
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Employee Status:
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
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