Job Description

We are currently looking for a: (Assoc.) Clinical Operations Manager

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company’s 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 budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

Responsibilities

Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).

Oversees and tracks clinical research-related payments.

Executes and oversees clinical trial country submissions and approvals 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.

Contributes to the development of local SOPs. Oversees CTCs as applicable.

Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. Collaborates closely with Headquarter to align country timelines for assigned protocols.

Provide support and oversight to local vendors 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 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. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.

Qualifications

Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience

Min. 2-3 years of experience in clinical research or combined experience in Clinical Research and Finance/Business

Experience in either regulatory or finance functions, with additional experience in both is considered a strong advantage.

Problem solving is essential to this position. Requires the ability to pro-actively identify issues and risks, analyse root cause, and propose solutions to problems and escalate to management as applicabl

Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills.

High sense of accountability and urgency in order to properly prioritize deliverables

Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and English.

Ability to focus on multiple deliverables and protocols simultaneously is essential.

We offer an attractive compensation package, outstanding benefits, and an exciting work environment with varied tasks in an international environment. The position’s seniority will be aligned with the candidate’s demonstrated experience and skills.

Current Employees apply HERE

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Adaptability, Business, Clinical IT, Clinical Research, Clinical Trial Management, Clinical Trials Operations, Clinical Trial Support, Data Analysis, Data Management, Drug Development Research, Global Clinical Studies, Good Clinical Data Management Practice (GCDMP), ICH GCP Guidelines, Interpersonal Relationships, Management Process, Process Operations, Regulatory Compliance, Scientific Writing, University Education

 Preferred Skills:

Job Posting End Date:

08/11/2025

*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.

Requisition ID:R358751