Senior Manager, Asset Lead, Clinical Data Sciences, Clinical Data Sciences

Use Your Power for Purpose

You will bridge evidence-based medical decision support with colleagues and stakeholders to enhance health and treatment outcomes. Whether developing frameworks to ensure our evidence is scientifically robust, providing unbiased and medically essential expertise, or investigating ways to close data gaps, your work will be pivotal in ensuring that accurate, timely, and consistent data reaches clinical teams and other groups. Your dedication will help Pfizer achieve new milestones and assist patients worldwide.

What You Will Achieve

ROLE SUMMARY

As part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Clinical Development & Operations (CD&O) 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 have direct reports.

 

ROLE RESPONSIBILITIES

• As needed, serve as Clinical Data Scientist & Trial Lead for one or more clinical trials assuming responsibility for all CDS 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 CDS is in accordance with applicable SOP’s 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.

• Key data management contact for regulatory inspections/audits in liaison with the appropriate Quality and Safety groups with Pfizer.

Here Is What You Need

• 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 8 years Data Management experience required including 3+ 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 (e.g.  Medidata RAVE, Oracle RDC / Inform, etc)

• Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g. Spotfire, review)

• Familiarity with Med DRA/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

• Bachelor’s degree required.  Degree in scientific field preferred.  Master’s degree preferred.

EEO (Equal Employment Opportunity) & 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, or disability.

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.

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