Clinical Operations Manager
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Key details
Job Description
Job Description
Shape the Future of Healthcare: Clinical Operations Manager
Location: Country Operations (Hybrid)
Position Type: Full-time
Function: Global Clinical Trial Operations
About Our Organization
At our company, we are driven by a shared purpose: discovering, developing, and delivering transformative therapies that improve and extend lives. Innovation thrives when talent, precision, and passion unite. By joining our team, you become part of a collaborative, diverse environment where your expertise directly accelerates breakthroughs in global clinical development.
The Opportunity
Are you an experienced clinical research professional with a strategic mindset for trial execution, regulatory submissions, and budget negotiations?
We are seeking a proactive, solution-oriented Clinical Operations Manager to drive country-level performance and compliance across assigned clinical trial protocols. In this pivotal role, you will take ownership of clinical study start-up, budget formulation, contract negotiation, and regulatory approvals. You will serve as the crucial link between investigator sites, regulatory bodies, and internal cross-functional teams to ensure our clinical trials are launch-ready on time and to the highest standards.
What You Will Do
As a key leader in country trial execution, your responsibilities will include:
- Budget & Contract Ownership: Lead the development, negotiation, and execution of Clinical Trial Research Agreements (CTRAs) and site budgets within fair market value. Oversee trial financial tracking, payment reconciliations, milestone tracking, and financial compliance (including FCPA and anti-corruption requirements).
- Submission & Regulatory Oversight: Direct country-level regulatory authority and IRB/IEC submissions and approvals for assigned protocols. Ensure all local language materials, patient-facing documents, and informed consents are accurately translated and compliant with ICH/GCP and local laws.
- Trial Acceleration & Site Readiness: Partner closely with Clinical Research Associates (CRAs), Clinical Trial Coordinators (CTCs), Finance, and Legal to remove bottlenecks and achieve milestone readiness for trial sites.
- Quality & Compliance Leadership: Champion local protocol adherence and compliance in line with our organization’s quality standards, global standard operating procedures (SOPs), and adverse event reporting guidelines.
- Cross-Functional Collaboration & Influence: Coordinate effectively with local and international stakeholders, headquarters teams, vendors, and investigative sites to align timelines, resolve study risks, and maintain operational excellence.
- Continuous Improvement & Mentorship: Act as a Subject Matter Expert (SME) and mentor within the clinical operations team, sharing best practices, leading value-add projects, and training emerging talent.
What You Bring to the Team
- Professional Experience: Extensive progressive experience in clinical research, or an equivalent combination of clinical research and clinical trial finance/business operations.
- Education:Bachelor’s degree in Life Sciences, Business Administration, Finance, or equivalent healthcare/scientific experience.
- Core Skills & Technical Acumen:Demonstrated expertise in clinical trial budget negotiation, contract terms (CTRAs), and local regulatory submission pathways.Deep familiarity with ICH/GCP guidelines, local country healthcare regulations, and clinical management systems/metrics.Proven ability to proactively identify risks, lead root-cause analyses, and implement effective mitigation strategies independently.
- Behavioral & Interpersonal Strengths:Exceptional negotiation, influencing, and interpersonal skills, with the credibility to partner effectively with investigators, hospital administrators, and external authorities.High sense of accountability, strategic prioritization, and agility in managing multiple priorities in a dynamic, hybrid work setting.Fluency in English and the local language (both written and spoken).
Why Choose Our Company?
- Meaningful Impact: Your daily work directly enables life-saving and life-enhancing clinical therapies to reach patients faster.
- Culture of Empowerment: We encourage independent decision-making, continuous learning, and cross-functional leadership.
- Comprehensive Growth: Access structured mentorship programs, continuous professional development, and opportunities to lead high-visibility global initiatives.
- Total Well-being: We offer competitive compensation, comprehensive health benefits, flexible working arrangements, and an inclusive work culture.
Ready to Make a Difference?
Take the next step in your clinical operations career and help us bring scientific innovation to life.
Apply today to join our organization.
Closing date for application: 20/11/2026
Additional location(s) Compensation Information:
Required Skills:
Clinical Research, Clinical Trial Agreements (CTA), Clinical Trial Compliance, Clinical Trial Documentation, COM Clients, Cross-Cultural Awareness, ICH GCP Guidelines, Incident Reporting, Regulatory Compliance, Regulatory Submissions, Risk Management, Serious Adverse Event ReportingPreferred 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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
11/21/2026*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.
