Sr. Clinical Data Manager

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Join Our Team as a Sr. Clinical Data Manager - Remote Position

Position Summary: At Precision for Medicine, we are looking for a dedicated Sr. Clinical Data Manager to join our team. This 100% remote role will manage all aspects of the clinical trial data management process from study start-up to post-database lock. You will guide projects following SOPs, regulatory directives, and specific plans and guidelines. Besides managing the database development and testing, the role involves crucial oversight responsibilities.

Key Responsibilities:

  • Serve as the primary Data Management contact for the clinical projects, ensuring effective management, continuity, and responsiveness.
  • Oversee the data entry process, develop guidelines, and ensure quality through direct oversight and training initiatives.
  • Engage in building and testing clinical databases while maintaining stringent quality control documentation.
  • Play a pivotal role in the creation, revision, and management of essential data management documentation, ensuring trial master file completeness.
  • Facilitate training sessions for clinical research staff on CRF, EDC, and other project-related elements.
  • Ensure accurate clinical trial data review and query in adherence to the Data Management Plan and sponsor guidance.
  • Lead SAE/AE reconciliation and liaise with third-party vendors to ensure timely deliverables and support project timelines.
  • Contribute to the development and revision of SOPs concerning data management and database activities.

Qualifications:

  • Minimum Required: Bachelor’s degree or equivalent combination of education and experience.
  • Other Required: At least 8 years of experience, proficiency in Microsoft Office, and strong leadership skills.
  • Preferred: Background in clinical, scientific, or healthcare discipline, understanding of CDISC standards, and experience with Oncology or Orphan Drug therapies.

Employment and Application Details:

Precision Medicine Group is committed to equal opportunity and diversity, which is reflected in our hiring practices. To apply, submit your information in adherence to the Privacy Policy. For specific accommodations related to disabilities, please contact [email protected].

If you have a passion for precision and impacting lives through rigorous data management, we would love to hear from you. This role offers the ability to work remotely, empowering you to balance life and work seamlessly. Join us in advancing the boundaries of clinical studies with Precision for Medicine.