Principal Clinical Data Manager, (Contract, Remote) ID-2210

Summary:

Elan Solutions, a staffing agency supporting one of our premier clients - A Clinical Research Organization (CRO), is seeking a highly experienced and detail-oriented Principal Clinical Data Manager (PCDM). This role entails overseeing the start-up and execution of multiple clinical trials, ensuring data quality and compliance with regulatory standards. The PCDM will manage complex studies, overseeing Data Management processes, budgeting, project timelines, and client interactions.

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Responsibilities:
  • Lead and manage all Data Management activities, ensuring quality, accuracy, and adherence to timelines.
  • Develop and refine Data Management processes, providing expertise to project teams, clients, and CROs.
  • Act as the primary escalation point for data management issues.
  • Ensure compliance with SOPs, study plans, and regulatory requirements.
  • Oversee and perform tasks such as database builds, User Acceptance Testing (UAT), and data cleaning activities.
  • Draft, review, and approve essential Data Management documentation (e.g., Data Management Plan, eCRF/Database Specifications).
  • Conduct data reconciliation, collaborating with external vendors as necessary.
  • Monitor and manage study budgets, handling forecasting, scope assessments, and change order processes.
  • Lead governance calls with clients and vendors, supporting project success and client satisfaction.
  • Supervise team members, providing feedback and training.

Qualifications:

  • Experience: Minimum 15 years of Data Management experience with at least 5+ years in a CRO.
  • Education: Bachelors degree (B.S./B.A.) in a science or technical discipline.
  • Technical Skills: Proficient in MS Excel; knowledge of SQL or SAS is beneficial.
  • Knowledge: Strong understanding of FDA, EMA, ICH guidelines, and GCPs related to clinical data management.
  • Communication: Excellent verbal and written skills; strong client and team interaction abilities.
  • Travel: Willingness to travel for client or team meetings if required.

Additional Skills: Strong attention to detail, prioritization, and time management skills; experience with budgeting and scope management

Principal Clinical Data Manager, (Contract, Remote) ID-2210

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