Study Manager, Epidemiology Operations
Merck
5 months ago
Remote friendly (North Wales, PA)
United States
Operations
Support the Lead Epi Scientists by providing overall operational support for observational/non-interventional research studies (including Post Authorization studies) in compliance with Good Pharmacoepidemiology Practice (GPP) and Standard Operating Procedures (SOPs).
Primary Responsibilities:
- Support operational planning and project management of epidemiology research studies
- Support execution and close out of primary data collection, chart review, database, and molecular epidemiology studies
- Provide vendor oversight (qualification, confidentiality agreements, specifications, contract reviews)
- Liaise with vendors and cross-functional teams to share project status and/or needs
- Assist with review and finalization of vendor documents (safety management, data management, communication, project management, validation plans)
- Participate in protocol and interim/final report preparation; shepherd documents through internal review for approval; upload to department repository
- Coordinate collection, international shipment, processing by internal/external labs, and data transfer for biospecimen-based studies
- Participate in quality control assessments; ensure integrity of study data for reports and publications
- Understand, coordinate, and document adherence to internal/external/regulatory compliance requirements
- Collaborate and troubleshoot issues with potential resolutions to ensure timely study execution
Education:
- Bachelor’s degree required
- Master’s degree (preferred)
- Degree in public health or closely related discipline (e.g., biostatistics, epidemiology, health administration, biological sciences)
Required Experience & Skills:
- 1+ year work experience in clinical/observational research (or equivalent)
- Basic knowledge of epidemiologic or outcomes research
- Solid project management and prioritization
- Excellent communication/interpersonal skills; ability to collaborate and influence stakeholders
Application:
- Current Employees apply HERE; Current Contingent Workers apply HERE
Primary Responsibilities:
- Support operational planning and project management of epidemiology research studies
- Support execution and close out of primary data collection, chart review, database, and molecular epidemiology studies
- Provide vendor oversight (qualification, confidentiality agreements, specifications, contract reviews)
- Liaise with vendors and cross-functional teams to share project status and/or needs
- Assist with review and finalization of vendor documents (safety management, data management, communication, project management, validation plans)
- Participate in protocol and interim/final report preparation; shepherd documents through internal review for approval; upload to department repository
- Coordinate collection, international shipment, processing by internal/external labs, and data transfer for biospecimen-based studies
- Participate in quality control assessments; ensure integrity of study data for reports and publications
- Understand, coordinate, and document adherence to internal/external/regulatory compliance requirements
- Collaborate and troubleshoot issues with potential resolutions to ensure timely study execution
Education:
- Bachelor’s degree required
- Master’s degree (preferred)
- Degree in public health or closely related discipline (e.g., biostatistics, epidemiology, health administration, biological sciences)
Required Experience & Skills:
- 1+ year work experience in clinical/observational research (or equivalent)
- Basic knowledge of epidemiologic or outcomes research
- Solid project management and prioritization
- Excellent communication/interpersonal skills; ability to collaborate and influence stakeholders
Application:
- Current Employees apply HERE; Current Contingent Workers apply HERE