Position Overview

Responsible for leading and overseeing all data management activities for research studies from study start-up to database lock in compliance with departmental SOPs and regulatory guidelines.

Responsible for executing, overseeing, and synchronizing the following activities: leading and coordinating initiatives to evaluate and implement efficiencies, protocol review, CRF design and development, development of database specifications, development of edit check specifications, development of the Data Management Plan, development of CRF Completion Guidelines, User Acceptance Testing (UAT), data review, query generation and resolution, data reconciliation, identification and review of protocol deviations, review of adverse events, and maintenance of study documentation in the electronic Trial Master File (eTMF). Job duties:
  • Provide mentoring and coaching to data management team members.
  • Contribute to the development of DM SOPs, Business Guidance, Work Instructions, and Standards.
  • Accountable and responsible for ensuring the delivery of high-quality Data Management deliverables and activities from protocol review through database closure and archiving.
  • Design high quality CRFs in consultation with cross functional partners that align to the data collection requirements identified in the study protocol, align with internal standards, and accurately reflect study endpoints.
  • Train internal and external personnel in the CDMS system(s), technology, applications, and Data Management process.
  • Maintain complete and accurate records of study data, reports, and documentation and files in the eTMF as appropriate to ensure compliance with departmental SOPs and all regulatory guidelines.
  • Perform, oversee, complete, and provide accurate review and processing of clinical trial data, including identification, resolution, and clarification of any missing, inconsistent, or clinically questionable data by the study team and/or sites.
  • Generate data management study status/progress overviews.
  • Participate in CRO evaluation.
  • Author, review, and/or approve data management study documents (e.g., eCRF specifications, annotated CRFs Edit Check specifications, eCRF completion Guidelines, Data Transfer Plans, etc.) and ensure documents are maintained and ready for regulatory inspection.
  • Leverage project management skills to support and oversee multiple projects both insourced and outsourced.
  • Perform other duties and responsibilities as assigned.

    1. Bachelor’s degree in life sciences, health sciences, or computer sciences field or equivalent combination of education, training, and industry related experience.
    2. A minimum of seven (7) years of clinical data management experience in the pharmaceutical, medical device, or Clinical Research Organization setting.
    3. A minimum of one (1) year of management or supervisory experience.
    4. Proven track record of strong project management skills and experience managing data management activities.
    5. Experience in vendor selection and management.
    6. Proven ability to prioritize and manage multiple tasks with conflicting deadlines in support of corporate goals and objectives.
    7. Advanced understanding of clinical data lifecycle including database design, data structure, database development and testing, query management, data quality review, and database lock procedures.
    8. Excellent written and verbal communication skills.
    9. Strong proficiency with Microsoft Office (e.g., Visio, PowerPoint, Word, Excel, Access, Outlook, Teams, etc.).
    10. Advanced understanding of ICH, ISO, GCP, and GDP guidelines.
    Desired Qualifications
    1. Advanced knowledge in GCP standards, FDA and ICH guidelines, and recommended CDM Best Practices.
    2. Hands-on experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission.
    3. Ability to identify data trends, problems and delays and escalate them appropriately to minimize their impact to the study.
    4. Experience in working with CROs/EDC vendors for data management activities.
    5. Highly organized with the ability to prioritize and manage multiple activities concurrently.