Senior Study Manager - 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.
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
- Adaptability
- Biostatistics
- Clinical Data
- Clinical Operations
- Clinical Study Design
- Clinical Trial Compliance
- Clinical Trial Management
- Clinical Trials
- Data Analysis
- Data Management
- Epidemiology
- Ethical Standards
- ICH GCP Guidelines
- Immunochemistry
- Immunology
- Medical Reporting
- Medical Writing
- Motivation Management
- Processing Expense Reports
- Project Management
- Project Prioritization
- Public Health
- Public Health Research
- Regulatory Compliance
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
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
