Pfizer Associate Director, Clinical Data Standards Lead, Central Services in Collegeville, Pennsylvania
As part of the Data Monitoring and Management (DMM) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Clinical Data Standards Lead is responsible for the integrity of clinical trial data standards. The Clinical Data Standards Lead will ensure the quality and consistency of clinical trial data standards to support the portfolio towards the ultimate objective of data quality and consistency across programs and systems. The Clinical Data Standards Lead will be accountable for the timely and high quality delivery of clinical trial standards in support of the Pfizer portfolio. The Clinical Data Standards Lead may oversee vendor and off-shore colleague deliverables supporting standards implementation.
Collaborates with department roles, cross-functional study team members and other functional lines to create data standards solutions that support the scientific need of a study/program while ensuring quality, consistency and compliance to CDISC standards that supports the exchange of data.
Serve as a subject matter expert on all aspects of standards development that includes industry standards (CDISC), regulations, legal mandates, processes, and business policies.
Key member of the global and Therapeutic Area (TA) standards governance boards to define, maintain and enforce standards across the Business Units to ensure consistency for internal and external run studies.
Ensure work carried out in accordance with applicable SOP's and working practices.
Key data standards contact for regulatory inspections/audits in liaison with the appropriate Quality and Safety groups with Pfizer.
Directly supports knowledge development of others as a subject matter expert on data standards, change control management and related tools/applications.
Creates quality control processes, metrics and other measures to ensure compliance with standards.
Creates any needed documentation and training for standard processes, change control management and tools.
Responsible for defining standards specifications working closely with implementation support teams (database set-up, completion guidelines, CRF designers, procedures, algorithm specifications and reporting requirements).
Facilitate a culture of continuous process improvement and a high level of customer service by maintaining and improving the standards processes associated with standards creation, maintenance, decision-making and implementation.
Support and Implement future strategies and technology-enabled processes and tools for clinical trials standards, change control management and the exchange of standards information to internal downstream consumers and externally consumers.
Bachelor's degree in a scientific discipline. Master's degree in Statistics, Computer Science preferred.
At least 10 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency. Experience in clinical data management and/or trial management experience with technical expertise in standards management and implementation preferred. Experience in the areas of design, support of large scale distributed databases and data standards administration.
Demonstrated knowledge of clinical research, metadata management, industry standards (CDISC), FDA & ICH, GCP, and related regulatory requirements
Demonstrated experience managing multiple tasks, complex projects and working with cross-functional teams delivering to project and portfolio timelines and metrics.
Strong verbal and written communication skills; independent and effective working in a multi-study, multi-disciplinary atmosphere in an matrix environment
Proficient experience using commercial clinical data management systems and/or EDC products (Oracle RDC/InForm preferred)
Proficient experience using commercial clinical data management systems and/or EDC products (Oracle RDC/InForm preferred
Experience using relational databases preferred (e.g. MDR, MS SQL Server, MS Access, or Oracle)
EEO & Employment Eligibility
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