Pfizer Clinical Data Scientist (Manager) in Los Angeles, California
This is may be a remote based role or on site at one of the Pfizer R&D locations:
Groton CT, La Jolla or San Francisco CA, Collegeville PA, NYC.
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
As part of the Data Monitoring and Management group, an integral delivery unit within the Global Clinical Trial Execution (GCTE) organization, the Clinical Data Scientist is responsible for timely and high quality data management deliverables supporting the Pfizer portfolio. The CDS Senior Manager delivers 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 Clinical Data Scientist designs, develops, and maintains 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.
Clinical Data Scientist
• Serve as Clinical Data Scientist for one or more clinical trials assuming responsibility for all DM&;M activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence
• Serve as a technical resource to the study teams for DM and RBM standards, tools, data provisioning, and reporting
• Partners with Research/Business Units and any external DM service provider to deliver high quality data management for all studies as assigned.
• Proactively drives quality and efficiency to meet timeline and milestones for data management, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with the cross functional study team (s).
• Ensure work carried out by DM providers is in accordance with applicable SOPs and working practices.
• Participates and ensures quality database design including documentation, testing and implementation of clinical data collection tools, both CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems.
• Ensure the required study-specific DM&;M documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously.
• Ensure operational excellence in collaboration with partners for application of standards, data acquisition, proactive data review and data integrity monitoring, data cleaning, e-data processing, data access and visualization, and database release.
• 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
• CRO and vendor oversight experience preferred
• Strong verbal and written communication skills
• Consistent, detail oriented, communicative, dedicated to do a job well done
• Minimum 5 years Data Management experience required
• Working 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, jReview)
• Familiarity with MedDRA/WHO-Drug
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
• Bachelor's degree or equivalent experience required.
Primarily an office-based position involving sitting, walking to meetings, making presentations, etc.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Ability to travel 10%.
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.A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.