Senior Manager, Real World Evidence

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Oversee the complete operational planning, execution, management, and closure of global and regional observational studies.

• Propel the implementation of prospective observational cohorts, disease registries, pragmatic studies, retrospective chart reviews, and secondary real-world data linkage initiatives.

• Facilitate collaborative study team meetings to ensure alignment among RWE, HEOR, Medical Affairs, Biostatistics, Data Analytics, Regulatory, and Legal/Privacy teams.

• Act as the primary point of escalation for operational risks, challenges with data access, and deviations from timelines.

• Manage documentation related to studies, including study master files, protocol versions, operational plans, data management plans, and archiving processes.

• Lead the creation and evaluation of operational plans, protocol synopses, observational research protocols, statistical analysis plans, and feasibility studies.

• Supervise informed consent templates, recruitment strategies, site selection, eCRF design, site contracting, data abstraction forms, database licensing, data transfer specifications, data linkage agreements, and variable mapping documents.

• Oversee protocol amendments and the submission packages for IRB/Ethics Committee approval.

• Coordinate the review and endorsement of final Study Reports and manuscripts.

• Manage relationships with external service providers, such as RWE CROs, data aggregators, academic research institutions, and chart abstraction vendors.

• Engage in vendor selection, RFP processes, SOW drafting, and contract negotiations.

• Monitor study timelines and budgets; analyze vendor invoices, milestones, and change orders.

• Track vendor deliverables and KPIs to ensure data quality, regulatory compliance, and adherence to protocols.

• Identify and mitigate operational and data-related risks.

• Ensure compliance with GPP, GCP where applicable, local and international regulations, HIPAA/GDPR, and internal SOPs.

• Serve as the operational lead and Subject Matter Expert (SME) during audits, quality reviews, and regulatory inspections.

• Provide updates on project status, milestone tracking, risk mitigation strategies, and budget to senior leadership.

• Lead cross-functional Study Execution Teams and matrix teams.

• Mentor and coach junior study managers, research associates, and project coordinators.

• Drive enhancements in operational processes, template updates, and refinements of SOPs.

⛳️ Requirements

• A minimum of 6 years of experience in research project management within biotechnology, pharmaceuticals, or contract research organizations (CROs).

• At least 3 years of dedicated experience in leading observational studies, encompassing both prospective and retrospective designs.

• Extensive operational knowledge of real-world data sources, including Flatiron, Optum, IQVIA, Datavant linkages, claims databases, and registries.

• Proficiency in 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.

• Demonstrated success in managing multi-site prospective observational studies and complex retrospective secondary data projects.

• Strong experience in contract, budget, and vendor oversight for RWE vendors, CROs, and data platform providers.

• Competency in electronic systems utilized in observational research, such as eTMF, CTMS, EDC, and data governance platforms.

• Exceptional organizational, time-management, and analytical abilities.

• Excellent cross-functional leadership, stakeholder management, and verbal/written communication skills.

• Capability to work effectively in matrixed environments across scientific, analytical, regulatory, and business units.

• Required: Bachelor’s degree in Life Sciences, Epidemiology, Public Health, Health Informatics, Healthcare Administration, or a related field.

🏝️ Benefits

• Discretionary annual cash bonus or incentive compensation.

• Discretionary equity grants.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401k retirement savings plan.

• Flexible paid vacation.