Senior Study Manager, Epidemiology Operations-3

MSD • North Wales, PA

1d • $117,000 - $184,200 • Remote

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). Manages several complex activities and study types.

Requirements

• Bachelor's degree required
• Five (5)+ years of work experience within clinical/observational research or equivalent experience; or PhD with 3+ years relevant career experience
• Excellent communication and interpersonal skills and the ability to collaborate with and influence a wide variety of stakeholders
• Knowledge of epidemiology and/or outcomes research
• Strong project management and prioritization skills
• Highly motivated, able to work independently and collaboratively

Nice To Haves

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

Responsibilities

• Operational planning and project management of epidemiology research studies
• Execution, and close out of primary data collection, chart review, database, and molecular epidemiology studies in addition to other activities
• Manage vendors including qualification efforts, confidentiality agreements, specifications, and contract reviews
• 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 extensively and troubleshoot issues by providing potential resolutions when necessary to ensure timely management and execution of studies
• Manage poster and publication development including: formatting, medical writing, figure/data content development, co-author review, internal review process, and journal submissions
• Conduct literature reviews
• Active participation in internal process improvement initiatives and mentoring of junior study managers

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
• annual bonus
• long-term incentive

What This Job Offers

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