Clinical Operations Manager

Job Description

At our company, we are dedicated to advancing healthcare through innovative clinical research. Our team is committed to excellence, collaboration, and continuous improvement in all aspects of our operations. We are currently seeking a highly skilled Clinical Trial Operations Manager to join our dynamic team.”

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 Lead or manager.
• Ability to lead a team of CTCs as applicable 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 applicable.
• Effective and efficient time management, strong coordination and organizational skills and interpersonal skills, conflict management and problem-solving skills.
• Strong communication both written and verbal in local language and English.

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, Adaptability, Clinical Operations, Clinical Site Management, Clinical Testing, Clinical Trial Agreements (CTA), Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Management Processes, Clinical Trial Planning, Clinical Trials Logistics, Clinical Trials Monitoring, Clinical Trials Operations, Compliance Assurance, Contract Management, Contract Negotiations, Cross-Cultural Awareness, Customer Experience Management, Healthcare Financial Management, ICH GCP Guidelines, Import-Export, Influencer Management, Insurance Administration, Insurance Planning {+ 15 more}

Preferred Skills:

Job Posting End Date:

05/28/2025

• 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.

Read Full Description