Job Description

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for supporting budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals.

Responsibilities include, but are not limited to:
- Support to country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
- Oversees and tracks clinical research-related payments. Payment reconciliation at study close- out.
- Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Support of Financial forecasting in conjunction with Sr. COM /other roles.
- Contribute to Execution and oversight clinical trial country submissions and approvals for assigned protocols.
- Develops local language materials including local language Informed Consents and translations. 
- Interact with IRB/IEC and Regulatory Authority for assigned protocols.
- Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors 
and sites, IRB/IECs and Regulatory Authorities in submission and approval related- interactions.

Your profile:
• 2-3 years of experience in Clinical Research or experience in Finance/Business
• Required: Associate Degree or equivalent Health Care related experience
• Preferred: Bachelor’s degree
- Good IT skills (MS office, Clinical IT applications) and ability to adapt to new IT applications on various devices.
• Knowledge of core clinical systems, tools and metrics
• Excellent verbal and written skills, in local language and English
• Knowledge of budget and contract negotiation process, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.
• High sense of accountability and urgency in order to properly prioritize deliverables
• Positive mindset, growth mindset, capable of working independently and being self-driven
 

Current Employees apply HERE

Current Contingent Workers apply HERE

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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

04/11/2025

*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.