Clinical Operations Manager Regulatory

Job description

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

budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

Responsibilities include, but are not limited to

• Ownership of 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 closeout.
  
  Oversees FCPA, DPS/OFAC, and maintenance of financial systems.
  
  Financial forecasting in conjunction with Sr.COM /other roles.
  
  
• Executes and oversees clinical trial country submissions and approvals for assigned protocols.
  
  
• Develops local language materials including local language Informed Consents and

translations.

Interacts with IRB/IEC and Regulatory Authority 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.

• Ownership of local regulatory and financial compliance.
  
  The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
  
  
• Required to in/directly influence investigators, external partners and country operations and adheres to budget targets and agreed payment timelines.
  
  
• 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.
  
  
• Contribute or lead initiatives and projects adding value to the business, as appropriate/required.
  
  
• 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 COM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required

Core competencies

• Expertise of core clinical systems, tools and metrics
• Excellent verbal and written influencing and training/mentoring skills, in local language and English
• Strong coordination and organizational skills
• 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 Sr.COM or manager.
  
  
• Ability to make decisions independently with limited oversight from Sr.COM or manager.
  
  
• Requires strong understanding of local regulatory environment
• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
  
  
• Ability to lead a team of CTCs as applicable

Behavioral Competency Expectations

• Problem solving is essential to this position.
  
  Requires the ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable.
  
  Specific examples of common problems include 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.
  
  
• 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.
  
  Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.
  
  
• Positive mindset, growth mindset, capable of working independently and being self-driven
• Able to directly influence site staff

Required
Experience Requirements

• 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business

Educational Requirements

Required

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

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
Project Temps (Fixed Term)

Relocation
No relocation

VISA Sponsorship
No

*Travel Requirements *
10%

Flexible Work Arrangements
Hybrid

Shift
Not Indicated

Valid Driving License
No

Hazardous Material(s)
n/a

*Required Skills *
Adaptability, Adaptability, Applied Engineering, Clinical Research, 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 Monitoring, Clinical Trials Operations, Cross-Cultural Awareness, Economic Forecasting, Financial Administration, Financial Forecasting, Global Sourcing, ICH GCP Guidelines, Management Process, Patient Recruitment, Pharmacovigilance, Problem Solving, Regulatory Compliance {+ 3 more}

*Preferred Skills
Job Posting End Date *
09/8/2025

• A job posting is effective until PM 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
R

Required Skill Profession

Other General