Senior Study Manager

MSD•North Wales, PA

2d•$117,000 - $184,200•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). Manages several complex activities and study types. Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. Primary responsibilities include: 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

Requirements

Bachelor's degree required in public health (or closely related discipline, such as biostatistics, epidemiology, health administration or biological sciences)
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
Accountability
Adaptability
Clinical Data
Clinical Operations
Clinical Study Design
Clinical Trial Compliance
Clinical Trial Management
Data Analysis
Deep Learning
Ethical Standards
ICH GCP Guidelines
Machine Learning (ML)
Medical Writing
Motivation Management
Regulatory Compliance
Regulatory Documents
Scientific Publications

Nice To Haves

Master's degree (preferred)

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