Study Operations Manager

Job Description

Role Summary:

• Lead end-to-end operational delivery of country specific data generation activities: Local Data Generation (LDG), Investigator Studies Program (ISP), post-approval research, and other in-scope interventional/non-interventional studies.
• Serve as the country study operations manager, accountable for project planning, execution, vendor oversight, budget management, compliance, and timely delivery of study milestones.
• Train local field medical/study leads on subjects related to study operations and corresponding SOPs.

Primary Responsibilities:

LDG:

• In collaboration with the study lead, who is overall accountable for the study, coordinates the end-to-end process for executing observational or non-interventional research studies in compliance with Good Pharmacoepidemiology Practice (GPP) and required procedural documents. This includes supporting the planning, initiating, executing on, and closing out of primary data collection, chart review, database, and molecular epidemiology studies in addition to other activities.
• Supports audit related activities/requests.
• Is mainly responsible for study-level project management, which includes:

o Review of request for information/proposals, drafts scope of work, and facilitates the execution of appropriate service, confidentiality, and vendor/consultant agreements and subsequent amendments/change orders

o Provides supplier oversight to ensure alignment with all SOPs and internal/external requirements

o Leads study meetings and drafts/reviews agenda/minutes/reports

o Tracks timelines/deliverables and follows up on action items

o Manage study-level budgets by tracking invoices/spend, navigate SAP/finance process, and collaborate with Finance and Budget Management organization

o Liaise with outsourced suppliers and CFT to communicate and oversee project status and/or needs

o Coordinate review and finalization of all supplier documents such as the safety management plan, data management plan, communication plan, project management plan, and validation plans

o Ensure adherence to internal, external, and regulatory compliance requirements

• Collaborates and troubleshoots with internal and external partners to ensure timely management and execution of studies, by providing potential resolutions when necessary; proactively drive mitigation and timely resolution.

o Utilizes, manages, and maintains document repositories and systems (e.g., REVOPs, Veeva Vault)

• Provides operational support for fair market value assessments, anti-bribery and corruption and due diligence checks, site contract and budget review/approval, informed consent review, timely registration of local studies (e.g.: CTRI) and required reporting, IT and privacy assessments, vendor qualification, AE reporting and reconciliation, and publication tracking for GMSA studies (abstracts, posters, oral presentations and manuscripts).

ISP:

• Coordinates the end-to-end process for executing Investigator Studies Programs in compliance with required procedural documents and local regulations.

• Is mainly responsible for study-level project management, which includes:

• Liaising communication between investigators and SLRM from protocol approval to study completion

• Coordinating the agreement of study contracts and managing status updates throughout the study
• Providing safety reports to investigators per the institutions' IRB policy if applicable
• Managing the local process regarding investigational drugs to sites in collaboration with HQ supply manager
• Making payment to institutions and managing source documents in good documentation practices
• Ensuring regular updates to i-Envision

In the discharge of your responsibilities, you will be required to undertake such other jobs as may be assigned to you by the Management from time to time.

Required Qualifications:

• Bachelor's or Master's degree in pharmacy, life sciences, or related healthcare/scientific discipline.
• 3+ years in clinical/observational research with 1.5+ years leading complex, multi-stakeholder study projects; pharmaceutical industry experience required.
• Demonstrated expertise in project management, vendor oversight, and budget planning/ management.

Core Competencies:

• Strong project management and execution discipline; sense of urgency and ability to manage multiple studies independently in a fast-paced environment.
• Deep working knowledge of study operations: GCP/GPP, IRB/HA submissions, site initiation/ close-out, site management, study drug import/supply, safety reporting, and compliance.
• Excellent interpersonal, verbal, and written communication; effective cross-functional stakeholder management.
• Problem-solving, resourcefulness, and adaptability; comfortable with ambiguity
• High attention to detail, data interpretation skills, and proficiency with study/document systems

Required Skills:

Clinical Data Management, Clinical Medicine, Clinical Research Management, Clinical Study Management, Clinical Trial Planning, Dedication to Patient Care, Ethical Standards, Identifying Customer Needs, Medical Affairs, Medical Review, New Technology Integration, Pharmaceutical Development, Pharmaceutical Quality Assurance, Protocol Development, Regulatory Submissions, Risk Management, Stakeholder Communications, Therapeutic Knowledge

Preferred Skills:

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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

11/29/2025

• 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.

Requisition ID:R373321