Clinical Operations Manager

MSD; Gurugram District; Vor Ort; INR 1.200.000 - 2.000.000; Vollzeit

Zusammenfassung

Merck Sharp & Dohme LLC in India invites a Clinical Operations Manager to ensure performance and compliance for assigned protocols in country, in line with ICH/GCP and local regulations. This role oversees budgets, CTAs, and country submissions, ensuring site readiness and timely deliverables.

You will interact with IRB/IEC and Regulatory Authority, develop local language materials, manage country timelines, and mentor COM team members in a collaborative, global environment.

Qualifikationen

• Experience in managing clinical trial budgets, CTAs, and country-level financials.
• Strong knowledge of local regulatory environment and submission processes.
• Ability to coordinate with cross-functional teams and external partners.
• Fluent in English; local language skills are a plus.

Aufgaben

• Own country and site budgets and CTAs.
• Oversee country submissions and approvals for protocols.
• Develop local language materials and translations for consent forms.
• Interact with IRB/IEC and Regulatory Authority for assigned protocols.
• Manage country timelines and ensure quality and compliance.

Kenntnisse

Budget management

Regulatory submissions

IRB liaison

Vendor management

Team leadership

Cross-functional

Ausbildung

Bachelor's degree

Life Science

Health care experience

Jobbeschreibung

Job Description Clinical Operations Manager

Brief Description of Position

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, internal 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 close-out. 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.

Qualifications, Skills & Experience Core competencies:

• Expertise of core clinical systems, tools and metrics
• Excellent verbal and written influrencing 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 elevate 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: Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Additional location(s)

Employee Status: Regular

Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s):

Job Posting End Date: 10/22/2026 *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.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA