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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 oversee the design, documentation, testing and implementation of clinical data collection tools, both CRF and non-CRFs using 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 customized 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.
QUALIFICATIONS
- Bachelor’s degree required. Degree in scientific field preferred. Master’s degree preferred.
- Minimum 8 years Data Management experience required including 3+ years team leadership
- 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
- Proficient experience using commercial clinical data management systems and/or EDC products (e.g. Medidata RAVE, Oracle RDC / Inform, etc)
- Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
- Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g. Spotfire)
- Familiarity with MedDRA/WHO-Drug coding
- Knowledge of risk-based monitoring principles & associated analytics/metrics
- Proven experience in vendor oversight to meet aggressive timelines of high-quality data deliverables
- Strong Project and Risk Management
- Strong verbal and written communication in English skills; independently and effectively in multi-study, multi-disciplinary atmosphere in a matrix environment
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Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
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