Clinical Operations Manager

Merck Gruppe - MSD Sharp & Dohme; Rahway (NJ); Hybrid; USD 90,000 - 120,000; Full time

Job summary

A leading company in healthcare is seeking a Clinical Trial Operations Manager to oversee clinical trial operations, manage budgets, and ensure compliance. The ideal candidate will have strong leadership and problem-solving skills, with a focus on collaboration and continuous improvement.

Qualifications

• Strong knowledge of budget and contract negotiations.
• Ability to influence investigators and vendors.
• Leadership skills to manage a team.

Responsibilities

• Ownership of country and site budgets.
• Execute and oversee clinical trial submissions.
• Manage country deliverables and timelines.

Skills

Adaptability

Clinical Operations

Clinical Site Management

Clinical Testing

Problem-Solving

Communication

Job description

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.

• Execute and oversee clinical trial country submissions and approvals for assigned protocols. Interact with EC and Regulatory Authority (RA) for assigned protocols.

• Manage country deliverables, timelines, and results for assigned protocols to meet country commitments. Ensure quality and compliance in assigned protocols in country. Oversee CTCs as applicable.

• Oversee and coordinate local processes, including clinical and ancillary supplies management, importing/exporting, supplies destruction, electronic/hard copy filing, archiving, retention, and insurance processes. Enter and update country information in clinical and finance systems.

• Collaborate internally with GCTO CO, finance, regulatory affairs, PV, legal, regional operations, HQ functions, and externally with vendors, sites, ECs, and RAs for submission and approval interactions.

• Contribute to the COM team and other Country Operations roles by acting as a process Subject Matter Expert (SME), sharing best practices, recommending continuous improvements, and providing training as needed.

• Assist in developing local SOPs and mentor team members by sharing best practices.

Qualifications:

• Strong knowledge of budget and contract negotiations, local regulatory environment, and submission/approval processes impacting study start-up.

• Ability to influence investigators, vendors, partners, and country managers to resolve issues with minimal support.

• Leadership skills to manage a team of CTCs as applicable.

• Proactive problem-solving skills, including issue and risk identification, root cause analysis, and solution proposals.

• Excellent time management, coordination, organizational, interpersonal, conflict management, and problem-solving skills.

• Strong communication skills in both local language and English.

Current Employees apply HERE

Current Contingent Workers apply HERE

Additional Information:

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted without a valid written agreement will be deemed the property of our company. No fee will be paid if a candidate is hired through an agency referral without an agreement. 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, 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, and more.

Preferred Skills:

Details not specified.

Job Posting End Date: 05/28/2025

*A job posting is effective until 11:59:59PM on the day before the listed end date. Please apply before this date.