MSD Clinical Operations Manager Job Opening – Apply Online
Clinical Operations Manager
Location: Gurgaon, Haryana, India
Job Type: Full time
Job Description
This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our 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, execution, and oversight of clinical trial country submissions and approvals.
- Ensuring 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).
- Overseeing and tracking clinical research-related payments.
- Payment reconciliation at study close-out.
- Overseeing FCPA, DPS/OFAC, and maintenance of financial systems.
- Financial forecasting in conjunction with Sr. COM/other roles.
- Executing and overseeing clinical trial country submissions and approvals for assigned protocols.
- Developing local language materials, including local language Informed Consents and translations.
- Interacting with IRB/IEC and Regulatory Authority for assigned protocols.
- Managing country deliverables, timelines, and results for assigned protocols to meet country commitments.
- Ensuring quality and compliance in assigned protocols in the country.
- Contributing to the development of local SOPs.
- Overseeing CTCs as applicable.
- Coordinating and liaising with CRM, CTC, CRA, (Finance and Legal, if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs, and local milestones.
- Collaborating closely with Headquarters to align country timelines for assigned protocols.
- Providing support and oversight to local vendors as applicable.
- Overseeing and coordinating 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.
- Entering and updating country information in clinical and finance systems.
Additional Responsibilities:
- Ownership of local regulatory and financial compliance.
- Directly or indirectly influencing investigators, external partners, and country operations to adhere to budget targets and agreed payment timelines.
- Working in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas, and externally with vendors, sites, IRB/IECs, and Regulatory Authorities in submission and approval-related interactions.
- Contributing or leading initiatives and projects adding value to the business, as appropriate/required.
- Acting as a process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required.
- Acting as a buddy/mentor and sharing best practices as appropriate/required.
Qualifications, Skills & Experience
- Expertise in 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, 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 the Sr. COM or manager.
- Strong understanding of the 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 skills are essential. Requires the ability to pro-actively identify issues and risks, analyze root causes, propose solutions, and escalate to management as applicable.
- Effective time management, organizational, and interpersonal skills.
- Conflict management and problem-solving skills.
- High sense of accountability and urgency to prioritize deliverables.
- Strong communication, leadership, and negotiation skills.
- Positive and growth mindset, capable of working independently and being self-driven.
- Ability to focus on multiple deliverables and protocols simultaneously.
- 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.
Keywords: MSD career opportunities, Clinical Operations Manager job, Healthcare job Gurgaon Haryana, Clinical research job India, MSD hiring, Job opening MSD, Career at MSD. MSD Clinical Operations Manager Job Opening – Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebo
