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:

• Bachelors or Masters 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:

Preferred Skills:

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