- As part of the Data Monitoring and Management (DMM) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Asset Lead is responsible for timely and high quality data management deliverables supporting the Pfizer portfolio. Responsibilities include delivery of asset level information strategies and services for optimal use and reuse of internal and external information that will advance research, development, and commercialization of the Pfizer portfolio and further precision medicine. The Asset Lead is expected to manage large or several smaller assets and may directly or indirectly design, develop, and maintain key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data, oversees application of standards, data review and query management, and is accountable for quality study data set release and consistency in asset/submission data. The Asset Lead may have direct reports.
- As needed, serve as Clinical Data Scientist for one or more clinical trials assuming responsibility for all DMM activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence.
- Act as the key scientific and technical data management expert; may define and drive the data management strategy and standards for the Therapeutic Areas (TA) as well as RBM standards, tools, data provisioning, and reporting.
- Ensure work carried out by or on behalf of DMM is in accordance with applicable SOPs and working practices.
- Serve as Subject Matter Expert (SME) for and oversees the design, documentation, testing and implementation of clinical data collection tools, both CRF and non-CRFs using and electronic data capture (EDC) system and/or other data collection systems.
- Data Integrity planning and ongoing monitoring of conformance of data quality to plan over multiple assets, through the implementation of customize central data monitoring strategies using appropriate tools and analytics.
- Execution of clinical study data due diligence for acquisition/in-licensing and co-development deals, and clinical research collaborations as required.
- Key data management contact for regulatory inspections/audits in liaison with the appropriate Quality and Safety groups with Pfizer.
- Bachelor's degree required. Degree in scientific field preferred. Master's degree preferred. Or at least 18 years experience in data management.
- Demonstrated successful experience in all relevant clinical data management activities in a BioPharmaceutical or CRO setting.
- Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review.
- Strong Project and Risk Management.
- Minimum 10 years Data Management experience required including 5+ years team leadership.
- Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements.
- Proficient experience using commercial clinical data management systems and/or EDC products (Oracle RDC / InForm preferred).
- Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g. Spotfire, Review).
- Familiarity with MedDRA/WHO-Drug coding.
- Knowledge of risk-based monitoring principles and associated analytics/metrics.
- Proven experience in vendor oversight to meet aggressive timelines of high quality data deliverables.
- Strong verbal and written communication skills; independently and effectively in multi-study, multi-disciplinary atmosphere in an matrix environment.
- Eligible for Employee Referral Bonus: YES
- Can be Remote based
Relocation assistance may be available based on business needs and/or eligibility.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.Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. 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.