Job Description

This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, company policies and procedures and with quality standards internally and externally.

The person has ownership, oversight and impact on local regulatory and financial compliance and for out-tasking as applicable. Under the oversight of the CRD or COM manager, the person is responsible to manage/oversee a team of COMs and/or CTCs.

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.

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Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

06/30/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:06/30/2025

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R314713