Pfizer Data Manager (Associate) in Groton, Connecticut
The mission of the Data Monitoring & Management (DM&M) organization is to strengthen the oversight of our clinical data through stronger ownership, control, and visibility of our clinical data. This is achieved through operational excellence in:
Definition and monitoring of key risk indicators to enhance our risk-based monitoring (RBM) strategies, and
Monitoring of the integrity and the flow of clinical data from our CROs, external electronic data sources, and third party studies into our internal systems to inform timely clinical development decisions.
The primary scope of this function is from database design to database release.
This position is responsible for supporting Clinical Data Scientists in delivering timely and high quality DM&M deliverables supporting Pfizer's portfolio. This position ensures excellence in the following:
Selection and application of data acquisition standards,
Data integrity monitoring, and
Key Accountabilities/Core Job Responsibilities (as assigned):
Support Clinical Data Scientists for one or more clinical trials in activities related to ensuring high quality, on-time data management deliverables
Participate in protocol review, focusing primarily on data management considerations and cross-study data collection consistency
Participate in the design, documentation, testing and implementation of clinical data collection tools using an electronic data capture (EDC) system and/or other data collection systems such as electronic patient reported outcome (ePRO). Includes requirements gathering per protocol, design of electronic case report forms (eCRF), including selection of standard data collection modules, and edit check specifications to meet the protocol's requirements
Create and maintain (or assist in the creation and maintenance of) supportive study documentation, such as Database Design Specifications, Data Quality Plan, CRF Completion Guidelines (CCG) and Data Management /Data Review Plans (DMP/DRP)
Prepare (or assist in the preparation of) data transfer specifications and data flow for all trial data, including CRF and non-CRF data
Participate in User Acceptance Testing (UAT) as needed
Review and maintain required study-specific DM&M documents in the Trial Master File (TMF)
Perform (or assist the CDS in) the review, and validation of clinical trial data throughout the study to ensure data integrity based on SOP and study/asset-specific guidelines
Generate data listings and/or data visualizations and participate in the ongoing review and cleaning of the data, including non-CRF data reconciliation (if applicable)
Perform data discrepancy management using documented procedures and guidelines as assigned, in conjunction with partners/vendors.
Perform metrics collection and reporting as needed
Support portfolio reviews as needed
Manage/Liaise (or assist the CDS to manage/liaise) with third party vendors for studies that have been contracted for DM activities and effectively communicate performance, timelines and outcomes with internal leadership
Provide input into continuous process improvements
Assist in developing CDS training materials
Bachelor's degree in scientific discipline or discipline requiring analytical thinking
Minimum of two years of demonstrated successful experience in previous job, co-op or internship. Clinical data management experience preferred.
Ability to work independently
Strong analytical skills
Strong verbal and written communication skills
Consistent, detail-oriented, communicative, dedicated to excellence
Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, Powerpoint, etc.)
Experience related to analyzing data and developing conclusions. Proficiency in SpotFire preferred.
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.
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Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.