Clinical Operations Manager

MSD LATAM; Tandil; On-site; ARS 900,000 - 1,300,000; Full time

Job summary

MSD LATAM is seeking a seasoned professional to oversee country budgets, CTAs, and regulatory submissions for assigned protocols. You will ensure site readiness, liaise with IRB/IEC and authorities, and manage local financial compliance while coordinating cross-functional teams.

The role requires strong budget negotiation skills, experience in clinical research and finance, and the ability to influence internal and external partners in a multinational environment.

Qualifications

• 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business.
• Bachelor’s Degree in Business, Finance, Administration or Life Science or equivalent Healthcare experience.

Responsibilities

• Own country and site budgets; develop, negotiate and finalize CTAs.
• Oversee clinical trial country submissions and approvals; ensure Site Ready.
• Interact with IRB/IEC and Regulatory Authority for assigned protocols.
• Coordinate local regulatory and financial compliance; manage timelines and milestones.
• Lead or contribute to local SOP development and vendor oversight.

Skills

Budget management

IRB/IEC liaison

Regulatory compliance

Clinical trial planning

Vendor management

Education

Bachelor’s degree in Business/Finance or Life Sciences

Tools

Financial systems

Contract negotiations tools

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.

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 Linemanager, 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

Behavioural Competency Expectations

• 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 escalation 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

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

Required Skills

• Adaptability, Adaptability, Adverse Event Reporting System, Adverse Events, Clinical Site Management, Clinical Supplies Management, Clinical Trial Agreements (CTA), Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials Monitoring, Clinical Trials Operations, COM Clients, Component Object Model (COM), Cross-Cultural Awareness, Financial Systems, ICH GCP Guidelines, Import Export Management, Incident Reporting, Insurance Administration, Line Management, Patient Recruitment, Payment Schedules, Pharmacovigilance {+ 7 more}

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

No Travel Required

Flexible Work Arrangements

Not Applicable

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

no

Job Posting End Date

11/6/2026

Requisition ID

R424358