Senior Manager, Clinical Trial Data Sharing External Demand Program Lead

Employer
Pfizer
Location
Groton, CT
Posted
Jun 23, 2022
Ref
4858130
Required Education
Bachelors Degree
Position Type
Full time
Role Summary

The Clinical Trial Data Sharing External Demand Program Lead, within the Clinical Trial Data Sharing Group 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. The Senior Manager will be responsible for operational execution, oversight, and compliance for all processes related to supporting Pfizer’s clinical trial external data sharing commitments. The Senior Manager will partner closely with Worldwide Medical & Safety Integrated Medical Operations Services members, colleagues in Global Product Development (programming, Information Management), legal, policy, and communications, as well as, external researchers, to ensure that the review, approval, and fulfillment of all external research requests for clinical trial data adhere to Pfizer SOP and standards. In addition, they will provide expertise for the successful delivery of the Participant Data Return Initiative, including day to day program management, resource management and end-user experience. The Senior Manager will also actively participate in and represent Pfizer in industry-wide initiatives and consortium related to clinical trial data sharing. Qualified candidate is a detail oriented, trained project leader, able to manage the technical nuances of clinical trial data while also possessing strong project management skills. Further, individual must thrive in a fast-paced, dynamic environment with the ability to anticipate a changing environment and aggressive timelines for delivery.

Responsibilities
  • Serves as main point of contact for all 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.

  • Takes an active role in Contributes to shaping Pfizer’s policies on Clinical Trial Data sharing and works with appropriate internal and external stakeholders to gather information to help formulate the policy and serves as Subject Matter Expert (SME) to communicate Pfizer and external clinical trial data sharing polices to internal and external audiences.

  • Leads periodic Clinical Trial Data Sharing Policy meetings and works collaboratively with colleagues in legal, communications, policy, medical and operations.

  • Manages existing external Cross-Industry partnerships supporting External Data Sharing, i.e. Transcelerate; Innovative Medicines Initiative (IMI); and evaluates membership in novel collaborations related to data sharing

  • Responsible for driving the day-to-day activities to meet the overall program objectives, product integration, and ensure Legal and safety compliance as well as documentation to support program

  • Coordinates with other stakeholders (Information Management, Data Management, & Clinical Trial Experience) to ensure all aspects of the program are in alignment with shared goals.

  • Responsible for defining business processes across WRDM and GPD to establish sustainable participant data return effectiveness.

  • Responsible for representing Pfizer on data sharing best practices in external forums and communities

  • Creates and maintains project timelines

  • Helps define project scope, goals, dependencies, and deliverables and identifies and directs all resources required to execute successful program

  • 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 deliverable sand use of performance metrics that measure and improve operational processes.

  • Partners with WMS/GPD Leaders to define and implement appropriate measures and establish performance targets in line with Pfizer’s vision and goals.

  • Manages external partnerships supporting Clinical Trial Data Return, i.e. Transcelerate Modernizing Clinical Trials and the Innovative Medicines Initiative FACILITATE program.

  • 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.

QualificationsMust-Have
  • BS in a relevant discipline preferred

  • 5-7 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.

Nice-to-Have
  • Master's degree/MBA


Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

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

Additional Job Information
  • Last Date to Apply: July 31, 2022

  • Work Location Assignment:Flexible

#LI-PFE

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

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