Manager, Clinical Data Scientist, Clinical Data Sciences
2 months ago
Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.
POSITION SUMMARY
As part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, You are responsible for timely and high quality data management deliverables supporting the Pfizer portfolio. You deliver 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. You design, develop, and maintain key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data, applies standards, data review and query management, and is accountable for quality study data set release and consistency in asset/submission data.
KEY RESPONSIBILITIES
Serve as Clinical Data Scientist and 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
Serve as a technical resource to the study teams for DM and Risk-Based Monitoring (RBM) standards, tools, data provisioning, and reporting
Partners with Research/Business Units, external DM service providers and internal CDS staff 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 or on behalf of CDS 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 CDS 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.
MINIMUM QUALIFICATIONS
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
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 (Oracle RDC / Inform preferred)
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
Bachelor's degree required. Degree in scientific field preferred.
PREFERRED QUALIIFICATIONS
Master's degree preferred.
PHYSICAL/MENTAL REQUIREMENTS
Primarily an office-based position involving sitting, walking to meetings, making presentations, etc.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Ability to travel approximately 5 to 10%
ORGANIZATIONAL RELATIONSHIPS
Reporting relationship to Asset Lead; Director, Group Lead; Associate Director, Asset Lead; Senior Manager, Asset Lead; Manager, Clinical Data Scientist, Clinical Data Sciences, CDS
Supports Study and Asset Teams across Pfizer Research and Development/Oncology Research and Development/Discovery and Early Development including Global Regulatory, Center of Excellence, Global Biometrics and Data Management and other internal organizations.
Vendor partnership of data managers and data analysts and others assigned to support data reporting deliverables.
RESOURCES MANAGED
Financial Accountability : Align delivery strategy to ensure responsible, efficient use of resources to deliver analyses required within budget. Accountable for accurate forecasting for future budget estimates and personal expenses.
Supervision: Manages work done by people within a matrix but may have responsibilities as a people manager in select cases.
This description indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent. Incumbent may be asked to perform other duties as required.
Work Location Assignment:Hybrid
The annual base salary for this position ranges from $93,500.00 to $155,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
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