Study Manager, Epidemiology Operations

MSD • Rahway, PA

5d • Hybrid

About The Position

Support the Lead Epi Scientists by providing overall operational support for study conduct. Responsible for the coordination and execution of observational or non-interventional research studies (including Post Authorization studies), in compliance with Good Pharmacoepidemiology Practice (GPP) and Standard Operating Procedures (SOPs). Primary responsibilities include: 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 in addition to other activities Provide vendor oversight including qualification efforts, confidentiality agreements, specifications, and contract reviews Liaise with the vendor and cross-functional teams to share project status and/or needs Assist with review and finalization of all vendor documents such as the safety management, data management, communication, project management and validation plans Participate in protocol and interim/final report preparation, shepherd document through the internal review process for approval, and upload to department repository Coordination of collection, international shipment, processing by internal/external labs and data transfer for biospecimen- based studies Participate in quality control assessments and ensure integrity of study data for reports and publications Understand, coordinate, and document adherence to internal, external, and regulatory compliance requirements Collaborate and troubleshoot issues by providing potential resolutions when necessary to ensure timely management and execution of studies

Requirements

• Bachelor's degree required
• One (1) or more years of work experience within clinical/observational research or equivalent.
• Basic knowledge of epidemiologic or outcomes research
• Solid project management and prioritization skills
• Excellent communication and interpersonal skills and the ability to collaborate with and influence a wide variety of stakeholders

Nice To Haves

• Master's degree (preferred)
• Degree in public health (or closely related discipline, such as biostatistics, epidemiology, health administration or biological sciences)

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 in addition to other activities
• Provide vendor oversight including qualification efforts, confidentiality agreements, specifications, and contract reviews
• Liaise with the vendor and cross-functional teams to share project status and/or needs
• Assist with review and finalization of all vendor documents such as the safety management, data management, communication, project management and validation plans
• Participate in protocol and interim/final report preparation, shepherd document through the internal review process for approval, and upload to department repository
• Coordination of collection, international shipment, processing by internal/external labs and data transfer for biospecimen- based studies
• Participate in quality control assessments and ensure integrity of study data for reports and publications
• Understand, coordinate, and document adherence to internal, external, and regulatory compliance requirements
• Collaborate and troubleshoot issues by providing potential resolutions when necessary to ensure timely management and execution of studies

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays, vacation, and compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level