Manager, Clinical Data Management

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Manager, Clinical Data Management – San Francisco, CA or Kolkata, India

You have worked with several cross-functional teams, across geographic locations to manage clinical data. Here is your next challenge.

  • Responsibilities:
    • Develops Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements.
    • Provide support to Clinical Operations team and/or study project, and Biostatistics team.
    • Develop and review Protocols, Case Report Forms, Reports and Statistical analysis reports.
    • Develop trial database, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
    • Develops Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
    • Reconcile electronic data transfers from vendor to Sponsor.
    • Develop test scripts and execution logs for User Acceptance Testing (UAT).
    • Coordination of UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
    • Manage EDC users and other Clinical databases, including but not limited to, compiling master user lists and activating/deactivating user accounts.
    • Perform training and create user guides.
    • Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to: data reconciliation and/or coding.
    • Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
    • Coordinate the archiving of study databases and related documents.
    • Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs.
    • Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB, including but not limited to, performing MedDRA and/or WHO coding.
    • Assist and provide input into study and project level data analysis plan.
    • Collaborate with IT and implementation team(s) to address Clinical application requests and/or changes to Clinical database systems.
    • Participates in the preparation and presentation of data, when applicable.
    • Ensures data system compliance by following the established guidelines of national and international regulatory authorities.
    • Participate in conference calls and/or meetings with vendors.
  • Qualifications:
    • Bachelor’s degree in Technology, Medicine, Science or related field.
    • At least five (5) years data management and/or related work experience in a medical device or pharmaceutical industry/company.
    • Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
    • Working knowledge of Clinical database applications such as EDC and CTMS.
    • Project coordination
    • Excellent verbal and written skills, good organizational, interpersonal, and team skills.
    • Applicable knowledge working with other clinical databases such as Oracle Clinical, Medidata Rave, SAS, other.
    • Experience with working on Phase I- IV study trials within the medical device and/or pharmaceutical industry.
    • Experience with AE Coding, if applicable.

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