Study Manager, Epidemiology Operations

Merck • North Wales, PA

1d • $96,200 - $151,400 • 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).

Requirements

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

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
• compassionate and sick days

What This Job Offers

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