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 appropriate.
- Possess strong business acumen and ability to navigate across functional lines, progress deliverables when there is ambiguity, anticipate business needs and demonstrate flexibility by adapting to changing business.
- Oversee operational execution for disclosure for products within remit, including but not limited to, registering clinical trial information, and posting study results on ClinicalTrials.gov, EudraCT, and Pfizer.com.
- Disclosure SME and liaison to study teams in communicating Pfizer disclosure policies, processes, and system requirements to ensure compliance.
- Utilizes internal and external systems and input from study teams for all disclosure‐related activities, including project management, authoring, reporting, and tracking.
- Provides metrics and other compliance‐related information to senior leadership related to the products and/or studies within their remit.
- Collaborateswith Data Sharing & Disclosure team members to ensure consistency and management of best practices.
Qualifications:
- MBA, MS/BS in a relevant discipline preferred
- 5-10 years working in the pharmaceutical industry in a project management capacity.
- Candidate should have strong technical skills including (at a minimum) expertise in Microsoft Office applications (Excel / PowerPoint)
- Strong track record for delivery
- Experience with drug discovery and development in a global matrix organization.
- Detailed knowledge of clinical trial and regulatory operations processes, data and supporting systems and tools.
- Excellent communication, organizational, and leadership skills
- Detailed knowledge of product development processes such as Agile, and a strong understanding of clinical development
- Experience with Electronic Medical Record systems, coding standards i.e. HL7, CDISC, FHIR, and data aggregation tools
- Strong verbal and written communication skills. Effective presentation and facilitation skills.
- Able to work and collaborate effectively as a trusted partner with stakeholders.
- Conversant with the long-term strategy of the business and is able to leverage this in order to prioritize activities and answer key business questions.
- High competency in disassembling complex problems, developing pragmatic solutions and providing guidance based on analytical output.
- Seeks quality information and provides analyses and recommendations supported by facts. Able to effectively visualize patterns to identify KPI’s.
- Contributes to a learning environment by sharing knowledge and best practices within and across the organization.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Ability to accommodate global/virtual meetings, as needed for assignments or projects, outside of normal working hours (early mornings and evenings)
- Overnight travel may be required
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Medical