Manager, Data Sharing & Disclosure

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About the role

The Data Sharing & Disclosure Manager, requires excellent project management skills coupled with knowledge of clinical trials, including but not limited to, protocol development, data management, data analysis, and/or study reporting. They will also influence cross-functional and virtual teams in a fast-paced environment with aggressive deadlines in a continually evolving transparency landscape. This role will be responsible for operational execution and oversight for all processes related to supporting Pfizer’s public disclosure of study information and study results commitments on ClinicalTrials.gov, EudraCT, and Pfizer.com. In addition, they will also be responsible for operational execution, oversight, and compliance supporting Pfizer’s clinical trial internal and external data sharing commitments. Further, the individual must thrive in a fast-paced, dynamic environment with the ability to anticipate a changing environment and aggressive timelines for delivery. Primary Activities Include: • Partner closely with Pfizer study teams in clinical, medical, legal, statistics and external business partners to ensure registrations and results postings adhere to internal policy and meet the requirements of public registry websites. • Conduct quality reviews of disclosure deliverables and assist in gathering metrics for drug programs within their remit. They will also be responsible for operational execution, oversight, and compliance for all processes related to supporting internal and external data sharing commitments. • Partner closely with Worldwide Medical & Safety Integrated Medical Operations Services members, colleagues in Global Biometrics & Data Management, Information Management, legal, policy, and communications, as well as external researchers. Ensure that the review, approval, and fulfillment of research requests for clinical trial data adhere to Pfizer policy and standards. Roles and Responsibilities : ·        Serves as a point of contact for internal & external clinical trial data requests – ability to review and triage requests for completeness and perform appropriate follow-up with external and internal stakeholders. ·        Manages tracking status of all clinical trial data requests and proactively identifies requests that are at risk for delays in dissemination of data – works with internal and external stakeholders to remediate and resolve. Provides detailed metrics and other information related to data requests. ·        Contributes to shaping Pfizer’s policies on Data Sharing & Disclosure and works with appropriate stakeholders to gather information to help formulate the policy and serves as Subject Matter Expert (SME) to communicate Pfizer polices to internal and external audiences. • Tracks project performance, specifically to analyze the successful completion of short- and long-term goals. • Meets budgetary objectives and adjusts to project constraints based on financial analysis • Leads cross-functional communication between project teams and external vendors and Interfaces and coordinate with outside vendors • Applies business expertise and project management excellence to the achievement of program deliverables and use of performance metrics that measure and improve operational processes.  • Partners with PRD Leaders to define and implement appropriate measures and establish performance targets in line with Pfizer’s vision and goals. • Enables sound decision making by Teams, Leadership and Governance by providing performance analyses, business insights and recommendations based on accurate and timely information. • Provide expert input to respond directly or indirectly to new business questions and challenges from leadership, while anticipating future needs and proactively addressing as approp

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