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Senior Associate, Senior Data Manager, Clinical Data Sciences,SH/BJ

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Pfizer

4.1

Multiple Locations

Why you should apply for a job to Pfizer:

  • 4.1/5 in overall job satisfaction

  • 4.5/5 in supportive management

  • 78% say women are treated fairly and equally to men

  • 79% would recommend this company to other women

  • 81% say the CEO supports gender diversity

  • Ratings are based on anonymous reviews by Fairygodboss members.
  • 23-25 Week Maternity Leave (Fully paid for birth parents)

  • Family building benefits include $35,000 fertility services + $25,000 adoption and surrogacy services

  • Pfizer is a founding member of Healthcare Businesswomen's Association Gender Parity Collaborative

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    Position summary

    Role Summary

    As part of the Data Monitoring and Management group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Data Manager is responsible for timely and high quality data review and query management of clinical data supporting the Pfizer portfolio.  The Data Manager develops and maintains key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data.

    Role Responsibilities

    • Serve as Data Manager for one or more clinical trials assuming responsibility for DMM activities including selection and application of data acquisition standards, database design (including specification documentation and testing of clinical data collection tools, both CRF and non-CRF, using an EDC system and/or other data collection systems), development and maintenance of the Data Management Plan, data review and query management, data access and visualization, Data Management metrics reporting, database release, and submission related activities.

    • In collaboration with the Clinical Data Scientist and Trial Lead, ensure operational excellence across all DMM deliverables.

    • Ensure work carried out in accordance with applicable SOPs and working practices.

    • Ensure the required study-specific DMM documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities. 

    • Ensure operational excellence in collaboration with CDS for application of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, DM metrics reporting, database release, and submission related activities.

    Qualifications

    • Demonstrated knowledge of clinical development process including knowledge and understanding of the principles of GCP

    • Demonstrated knowledge of data management processes and principles in area of responsibility.

    • Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review

    • Demonstrates strong verbal and written communication skills including ability to communicate remotely 

    • 3-5 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.  , Inform preferred) 

    • Experience using data visualization tools (e.g. Spotfire,  J-Review) preferred

    • Familiarity with MedDRA/WHO-Drug 

    • Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)

    • Bachelor’s degree minimum requirement. 

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

    Medical

    What are Pfizer perks and benefits

    Paid paternity

    Paid maternity

    About the company

    27839

    Pfizer

    Industry: Pharmaceutical

    Pfizer is a leading research-based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies that extend and significantly improve lives. We make medicines and vaccines that help people when they are sick and prevent them from getting sick in the first place. Every day, our colleagues work in developed and emerging markets to ...

    Why you should apply for a job to Pfizer:

  • 4.1/5 in overall job satisfaction

  • 4.5/5 in supportive management

  • 78% say women are treated fairly and equally to men

  • 79% would recommend this company to other women

  • 81% say the CEO supports gender diversity

  • Ratings are based on anonymous reviews by Fairygodboss members.
  • 23-25 Week Maternity Leave (Fully paid for birth parents)

  • Family building benefits include $35,000 fertility services + $25,000 adoption and surrogacy services

  • Pfizer is a founding member of Healthcare Businesswomen's Association Gender Parity Collaborative

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