MSD Sr GCTO 

Kenya, Nairobi County, Nairobi 

908424873

Job Description

Responsibilities include, but are not limited to:

• Has significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up:

FINANCIAL:

• Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
• Interacts successfully with local clinical team/s in order to deliver clinical and financial contracts within fair market value. Oversight and tracking of clinical research-related payments. Payment reconciliation at study close-out. Oversight of FCPA, Denied Parties Screening and maintenance of financial systems. Financial forecasting and tracking of operational budget in conjunction with CRD is an option that can vary per country.

MANAGEMENT & QUALITY OVERSIGHT:

• Responsible for managing country deliverables, timelines, and results in assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in the country. Contributes to the development of local/Int'l SOPs.
• Oversees CTCs and contract workers (e.g. CTCs) and local vendors and may manage COMs, both as applicable.

COLLABORATION:

• Works with minimal oversight from CRD or COM manager in close collaboration internally with GCTO Country Operations (CRM, CTC, CRA, COM, and CQM), Medical Affairs, PV, Regulatory Affairs, Business Compliance, our R&D department/Local finance departments, legal, HQ functional areas and externally with vendors and sites to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
• Collaborates closely with Regional Operations and/or Headquarters to align country timelines for assigned protocols.
• Provides support and oversight to local vendors as applicable.

LOCAL PROCESS OVERSIGHT:

• Oversight and coordination of local processes; local electronic/hard copy filing, insurance process management.
• Enters and updates country information in clinical, regulatory, safety, and finance systems.

Current Contingent Workers apply

Not ApplicableNot Indicated

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