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Job DescriptionThe Study Manager leads the operational planning, execution, and closure of non-interventional, observational research projects—encompassing both prospective studies (e.g., patient registries, prospective cohort studies) and retrospective studies (e.g., retrospective chart reviews, electronic health record [EHR] analyses, claims database studies, and secondary data assets). This role ensures operational excellence, cross-functional alignment, vendor oversight, budget management, and timely delivery of high-quality Real-World Evidence (RWE) to support clinical development, medical affairs, regulatory submissions, and value strategies. The Study Project Manager serves as a Subject Matter Expert (SME) in observational study execution, Good Pharmacoepidemiology Practice (GPP), data privacy compliance, and cross-functional study team leadership.
Essential Functions
Study Leadership & Operational Oversight
- Lead the end-to-end operational planning, implementation, management, and closeout of global and regional observational studies across prospective and retrospective designs.
- Drive the operational execution of prospective observational cohorts, disease registries, pragmatic studies, retrospective chart reviews, and secondary real-world data (RWD) linkage projects.
- Facilitate and lead cross-functional study team meetings (e.g., Study Execution Teams), ensuring alignment among RWE leads, HEOR, Medical Affairs, Biostatistics, Data Analytics, Regulatory, and Legal/Privacy.
- Serve as the primary point of escalation for study operational risks, data access hurdles, and timeline deviations, driving proactive resolution.
- Manage study-level documentation, ensuring maintenance of study master files, master protocol versions, operational plans, data management plans, and archiving in compliance with company standard operating procedures (SOPs).
Study Planning, Protocol Development & Documentation
- Lead cross-functional development and review of study-specific operational plans, protocol synopses, observational research protocols, statistical analysis plans (SAPs), and feasibility assessments.
- For prospective observational studies: Oversee informed consent form (ICF) templates, patient recruitment strategies, site selection, electronic Case Report Form (eCRF) design, and site contracting.
- For retrospective studies: Oversee data abstraction form design, EHR/claims database licensing, data transfer specifications, data linkage agreements, and variable mapping documents.
- Manage protocol amendments and IRB/Ethics Committee submission packages, supporting waiver of authorization applications for retrospective chart extractions or secondary data usage.
- Coordinate the review and approval of final Study Reports (SRs) and manuscripts in collaboration with publication and scientific communications teams.
Vendor & External Data Provider Oversight
- Accountable for the operational management and performance oversight of external service providers, including specialized RWE contract research organizations (CROs), data aggregators, academic research institutions, and chart abstraction vendors.
- Participate in vendor selection, Request for Proposal (RFP) processes, scope of work (SOW) drafting, and contract negotiations.
- Manage and track trial timelines and study budgets in line with projected spend; critically analyze vendor financial invoicing, milestones, and change orders.
- Monitor vendor deliverables and Key Performance Indicators (KPIs) to ensure data quality, regulatory compliance, and protocol adherence.
Risk Management, Governance & Compliance
- Identify, assess, and proactively manage operational and data-related risks to safeguard study quality, data privacy, and delivery timelines.
- Ensure all observational research activities comply with Good Pharmacoepidemiology Practice (GPP), Good Clinical Practice (GCP, where applicable), relevant local/international regulations, HIPAA/GDPR privacy rules, and internal SOPs.
- Act as the study operational lead and SME during internal audits, quality reviews, and regulatory inspections related to observational data generation.
- Support program-level governance discussions by providing timely project status, milestone tracking, risk mitigation strategies, and budget updates to senior leadership.
Leadership & Team Collaboration
- Lead cross-functional Study Execution Teams and matrix teams to maintain high performance and accountability.
- Mentor and coach junior study managers, research associates, or project coordinators.
- Drive operational process improvements, template updates, and SOP refinements within the RWE / Evidence Operations organization.
Required Knowledge, Skills, and Abilities
Experience:
- 6+ years of research project management experience in biotechnology, pharmaceuticals, or contract research organizations (CROs).
- Minimum 3+ years specifically focused on leading observational studies, including both prospective designs (registries, prospective cohorts) and retrospective designs (EHR/claims databases, chart reviews, secondary data analyses).
Observational Methodology & Data Knowledge:
- Deep operational understanding of real-world data sources (e.g., Flatiron, Optum, IQVIA, Datavant linkages, claims databases, registries).
- Knowledge of non-interventional study governance, ethics committee/IRB waiver processes, informed consent for observational cohorts, and health data privacy regulations (HIPAA, GDPR).
- Familiarity with Good Pharmacoepidemiology Practice (GPP) and ISPOR/ISPE guidelines for RWE execution.
Project & Vendor Management:
- Proven track record of managing multi-site prospective observational studies and complex retrospective secondary data projects.
- Strong contract, budget, and vendor oversight experience with RWE vendors, CROs, and data platform providers.
- Proficiency in electronic systems utilized in observational research (e.g., eTMF, CTMS, EDC, data governance platforms).
Communication & Leadership:
- Excellent organizational, time-management, and analytical skills.
- Outstanding cross-functional leadership, stakeholder management, and written/verbal communication skills.
- Ability to work effectively in matrixed environments across scientific, analytical, regulatory, and business units.
Required/Preferred Education and Licenses
- Required: Bachelor’s degree in Life Sciences, Epidemiology, Public Health, Health Informatics, Healthcare Administration, or a related field.
- Preferred: Advanced degree (Master’s or Ph.D.) in Epidemiology, Public Health (MPH), Health Economics, or Life Sciences.
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