Sr. Clinical Data Manager

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Join Our Remote Team as a Sr. Clinical Data Manager at Precision Medicine Group

Position Summary: As a Sr. Clinical Data Manager at Precision Medicine Group, you will oversee and manage every aspect of the data management process for clinical trials from start-up to post-database lock. Adhering to Standard Operating Procedures, regulatory directives, and specific planning, your role is crucial in ensuring the integrity and quality of clinical trial data.

This fully remote position offers you the flexibility to work from anywhere while playing a lead role in managing data for assigned clinical projects or programs.

Essential Job Functions:

  • Act as the primary contact for Data Management on assigned projects, ensuring effective management and timely communication.
  • Develop and oversee project data entry guidelines, training, and quality control.
  • Contribute to the creation and maintenance of database specifications and handle the database build and quality testing.
  • Ensure clinical data management timelines are met efficiently with high quality.
  • Design, revise and control data management documentation ensuring completeness for the Trial Master File.
  • Provide necessary training and conduct reviews and queries of clinical trial data as per the Data Management Plan.
  • Collaborate with third-party vendors and oversee external data-related deliverables.
  • Lead cross-functional team initiatives and provide strategic leadership in data management tasks.

Required Qualifications:

  • Bachelor's degree or relevant combination of education and experience.
  • Minimum of 8 years of experience in clinical data management.
  • Proficiency in Microsoft Office and various clinical database management systems.
  • Excellent organizational, communication, and leadership skills.
  • Professional proficiency in English (both written and oral).
  • Ability to engage in occasional travel as required.

Preferred Qualifications:

  • Background in a clinical, scientific, or healthcare discipline.
  • Experience with dictionary medical coding (MedDRA and WHODrug).
  • Familiarity with CDISC standards (CDASH, SDTM, ADaM, etc.).
  • Experience in Oncology and/or Orphan Drug therapeutic areas.

Equal Opportunity Employment

Precision Medicine Group is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

How to Apply:

If you have the skills required and a passion for precision in data management, we would love to hear from you. This role offers the chance to impact significant areas such as drug, device, and biologic development. Apply today to join our innovative team and contribute to advancing healthcare through data management.

For individuals needing accommodations or alternative application methods, please contact us at [email protected].

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