Note: The job is a remote job and is open to candidates in USA. Worldwide Clinical Trials is a global, midsize CRO committed to improving lives through innovative clinical research. The Principal Clinical Data Manager will oversee and manage complex data management projects, ensuring accuracy and timely delivery of data for regulatory submissions while providing mentorship and support to the team.

Responsibilities

• Oversee, lead, manage and provide technical expertise within the assigned complex projects/programs to ensure that they are executed in an efficient, accurate and timely manner 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
• To provide support to Business Development staff by participating in preparation of proposals and presentations to sponsors
• To participate as necessary in sponsor audits, regulatory authority inspections and other third party meetings

Skills

• 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

Benefits

• In addition to base salary, we offer a competitive benefits package depending on location.

Company Overview

Company H1B Sponsorship