Study Operations Manager – Clinical & Observational Research
Company: Merck & Co., Inc.
Location: Europe, Middle East, Africa, Latin America & Asia Pacific (Remote options may vary by country)
Employment Type: Full-Time
Position Overview
Merck & Co., Inc. is seeking an experienced Study Operations Manager to lead end-to-end operational delivery of country-specific clinical and observational studies, including Local Data Generation (LDG), Investigator Studies Program (ISP), post-approval research, and other interventional/non-interventional studies. This role is accountable for project planning, execution, vendor oversight, budget management, compliance, and timely delivery of study milestones, while supporting cross-functional teams and local field leads on study operations.
Key Responsibilities
Local Data Generation (LDG)
Coordinate observational and non-interventional research studies in compliance with Good Pharmacoepidemiology Practice (GPP) and applicable SOPs.
Support study planning, initiation, execution, and closeout activities including primary data collection, chart review, database management, and molecular epidemiology studies.
Provide project management at the study level, including:
Reviewing requests for information/proposals and drafting scopes of work.
Facilitating execution of service agreements, confidentiality agreements, and vendor contracts.
Oversight of suppliers to ensure compliance with SOPs and internal/external requirements.
Leading study meetings, documenting minutes, and tracking deliverables and action items.
Managing budgets, invoices, and SAP/finance processes in collaboration with Finance teams.
Maintain document repositories and study systems (REVOPs, Veeva Vault) and ensure regulatory and internal compliance.
Support fair market value assessments, anti-bribery compliance, site contracts, informed consent reviews, local study registration (e.g., CTRI), AE reporting, and publication tracking.
Investigator Studies Program (ISP)
Oversee end-to-end execution of ISP studies, ensuring adherence to local regulations and procedural documents.
Manage communication between investigators and study leads from protocol approval to study completion.
Coordinate study contracts, payment processes, investigational drug supply, source document management, and IRB submissions as applicable.
Ensure regular updates to internal study tracking systems (i-Envision) and timely reporting to stakeholders.
Cross-functional Collaboration
Train local field medical and study leads on study operations and SOPs.
Troubleshoot operational challenges, providing solutions to ensure timely study execution.
Liaise with internal and external partners to drive operational efficiency and compliance.
Required Qualifications
Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related healthcare/scientific discipline.
Experience: Minimum 3+ years in clinical/observational research, with at least 1.5 years leading complex, multi-stakeholder study projects in the pharmaceutical industry.
Demonstrated expertise in project management, vendor oversight, budget planning, and study execution.
Core Competencies
Strong project management and execution skills, managing multiple studies independently in a fast-paced environment.
Deep knowledge of study operations, GCP/GPP compliance, IRB/HA submissions, site initiation/closeout, investigational drug management, and safety reporting.
Excellent interpersonal, verbal, and written communication skills; effective cross-functional stakeholder management.
Proactive problem-solving, adaptability, and ability to navigate ambiguity.
High attention to detail, data interpretation, and proficiency in study/document management systems.
Required Skills
Clinical Data Management, Clinical Research Management, Clinical Study Management, Clinical Trial Planning, Medical Affairs, Regulatory Submissions, Protocol Development, Pharmaceutical Development, Stakeholder Communication, Risk Management, Therapeutic Knowledge, Quality Assurance, Ethical Standards.
SEO & GPT Optimized Keywords: Study Operations Manager jobs, clinical research operations, pharmacovigilance, observational studies, investigator-initiated studies, project management in pharma, multi-country clinical studies, pharmaceutical careers, Merck & Co. careers.
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