Advanced Medical Solutions (AMS) Data Lead

Role Summary
The AMS Data Lead is responsible for leading and executes end‑to‑end data management activities to ensure high‑quality, complete, and accurate information across diverse and complex projects.  This specialized role requires a unique skill set to work across internal and external stakeholders to ensure that the information in Advanced Medical Engagements meets Pfizer standards in a compliant and expedient way with deliverables and dissemination to support the field. 

This position reports to the Advanced Medical Solutions Team lead. The Data Lead collaborates with internal and external stakeholders including other members of the AMS team, study/project leads, contracted healthcare organization (CHCO) staff, business process operational leads and others as needed.

Primary Duties and Responsibilities
 

1) Quality & Compliance

• Maintain continuous quality improvement of data management-related processes and documentation to support compliance in an expedient manner

• Keep abreast of changes in internal and external requirements and identify and analyze potential impact for AMEs

• Maintain data management files of record for AMEs for compliance purposes

• Maintain compliance with data entry into relevant and proper Clinical Data Management Systems.

• Maintain compliance with regulations

• Support routine and ad hoc internal audits of projects.

• Ensure that the product/deliverable is the best it can be given time and budget constraints and work with leadership to address conflicts

2) Process Development & Documentation

• Develop and deploy data management templates across the AME process

• Develop and maintain processes for data management

• Assist in development, maintenance and management of processes and associated documents (e.g., case report forms/study worksheets)

• Assist in development of data management-related processes such as the Study Requirements Specification (SRS).

• Contribute to AMS and study/project-specific data management processes including but not limited to Data Management Plans, User Guides, Case Report Form Completion Guidelines, and other study documentation.

3) Study / Project Data Management Execution

• Lead end-to-end data management activities on projects/studies of diverse scope

• Review data for quality and resolve discrepancies.

• Perform data validation as appropriate (e.g., for studies with a database conduct database validation under the guidance of the Clinical Database Developer or Data Management department leadership).

• Develops and/or ensures quality in the database design including both CRF and non-CRF data collection modules, edit checks and data review listing, and other activities up to database release as appropriate

• Generate data output and coordinate data output documentation.

• Proactively drives quality deliverables as well as ensures timelines and milestones are met in collaboration with cross-functional teams.

4) Cross-Functional Collaboration & Stakeholder Engagement

• Collaborate with internal and external stakeholders to ensure all data is complete, timely, and accurate.

•  Work with cross-functional stakeholders to understand implications of updates

•  Lead discussions with healthcare organizations to educate on Pfizer requirements, training, SOPs and how they apply to the project at hand

5) Communication & Project Coordination

•  Strong communication and collaboration

•  Keep project plan or study calendar updated.

•  Contribute to dissemination activities as appropriate

REQUIRED QUALIFICATIONS

• 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.

• Bachelor’s degree in Computer Science, Mathematics, Life Sciences, Health‑related field, or similar.

• 6+ years of relevant experience required with BA/BS or 5+ years of relevant experience with MBA/MS

• Leadership, project management, resource management expertise.

• Strong communication and team development skills

• Experience managing without authority

• Minimum 3 years of experience managing clinical research data.

• Familiarity with EDC systems and clinical databases.

• Understanding of US and international d