Principal Clinical Data Manager - US/Europe - Remote

Worldwide Clinical TrialsDurham, NC
$99,000 - $196,000Remote

About The Position

Worldwide Clinical Trials is a global, midsize CRO that pushes boundaries and innovates to find cures for diseases. The Data Management team is a collaborative group responsible for clinical studies from database creation to final dataset delivery, ensuring data accuracy and integrity for regulatory submissions. The team fosters an environment that invites input, personal growth, and empowers professional journeys.

Requirements

  • Excellent attention to detail.
  • Excellent written and verbal communication skills.
  • Expert knowledge of data management best practices & technologies as applied to clinical trials.
  • Excellent communication and interpersonal skills to collaborate with cross-functional internal and external teams.
  • Advanced understanding of clinical trial process and protocols documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
  • Strong independent analytical and problem-solving skills.
  • Independent and autonomous project oversight skills.
  • Bachelor’s degree or higher in biomedical sciences, life sciences, computer science or related discipline — or equivalent relevant experience.
  • Min of 7 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries.

Responsibilities

  • Oversee, lead, manage and provide technical expertise within assigned complex projects/programs to ensure efficient, accurate, and timely execution to the Sponsor’s satisfaction.
  • Provide subject matter expert support, solution management, and departmental support for project initiatives and training.
  • Provide fully independent and autonomous leadership of data management services (start up, conduct and close out) across multiple complex global projects/programs.
  • Liaise with DM Management at regular intervals to discuss progress and any issues outstanding (e.g., during Project Review Meetings).
  • Collaborate with internal WCT departments working on the same project.
  • Provide mentorship to other members of the DM department.
  • Participate in and co-lead departmental initiatives for process improvement and efficiencies as defined by the DM Departmental leadership.
  • Deputise for Manager, DM as required.
  • Provide support to Business Development staff by participating in preparation of proposals and presentations to sponsors.
  • Participate as necessary in sponsor audits, regulatory authority inspections, and other third-party meetings.

Benefits

  • Competitive benefits package depending on location.
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