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Clinical Data Manager (Associate)

Pfizer


Location:
Collegeville, PA 19426
Date:
11/03/2017
2017-11-032017-12-04
Pfizer
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Job Details

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



Database design



Data flow



Data integrity monitoring, and



Data management







**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







**QUALIFICATIONS:**







+ 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







**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 ~10%







Additional Details:







+ Eligible for Employee Referral Bonus



+ Pfizer US/PR Grade 3







**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.







**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.







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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