Principal Clinical Data Manager - US/Europe

Worldwide Clinical Trials•Durham, NC

4d•Remote

About The Position

Worldwide Clinical Trials is a global, midsize CRO that pushes boundaries and innovates to find cures for diseases. Our Data Management team is a collaborative group of diverse individuals with extensive industry experience, involved in clinical studies from database creation to final dataset delivery. We ensure data accuracy and integrity for regulatory submissions. The team offers various roles and opportunities for career growth in an environment that encourages input, personal development, and professional empowerment.

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 outstanding issues (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 needed.
Support Business Development staff by participating in the preparation of proposals and presentations to sponsors.
Participate as necessary in sponsor audits, regulatory authority inspections, and other third-party meetings.