Principal Clinical Data Manager
Veristat
Summary
Working independently and in consort with management, the Principal Clinical Data Manager is responsible for the performance of data management tasks from study start-up through database lock for assigned clinical research projects, including paper-based and electronic data capture (EDC) studies, and is responsible for overall data quality and documentation on clinical research projects.
Job description
The Principal Clinical Data Manager will work on mid-to-large complex projects in various indications, at times serving as program manager, overseeing multiple studies under the same client. S/he will lead a team of CDMs to ensure all the contracted activities are carried out according to the Standard Operating Procedures of Veristat and/or Sponsor specific requirements.
In consort with Data Management leadership, the Principal Clinical Data Manager promotes consistent operations, efficient use of resources, and sharing of knowledge and best practices.
S/he, in consultation with the managers, will assist with the training of other data managers on project specific and general data management processes, procedures and systems, as well as providing training to other functions across the company as needed.
Requirements
- Bachelor's degree in a related field
- 7+ years of relevant experience
- At least 5 years' experience in clinical data management in a clinical research setting
- 4 years of experience in leading project teams
- Thorough knowledge of ICH GCP guidelines and other applicable regulatory rules and guidelines
- Knowledge of medical terminology, clinical trials, and clinical research
- Working knowledge of CRO industry regulatory obligations with pharmaceutical/biotech companies
- Demonstrated ability to lead by example and provide technical leadership of staff
- Demonstrated ability to serve as internal and external consultant and influence without authority
- Demonstrated ability to operate with the big picture in mind
- Expert level skills in clinical trial databases and applications (e.g., IBM Clinical Development, Medidata RaveX)
- Detailed understanding of project planning and management methods
- Excellent interpersonal, communication, and organizational skills
- Ability to work independently and in a team environment
- Ability to work on different projects with different priorities and act as team mentor
Benefits
- Remote working
- Flexible time off
- Paid holidays
- Medical insurance
- Tuition reimbursement
- Retirement plans
Company overview
Veristat is a science-first full-service clinical research organization (CRO) and consultancy that specializes in advancing complex and novel therapies through integrated strategic planning, regulatory expertise, and clinical trial execution. With nearly 30 years of experience, the company focuses on supporting emerging, small, and mid-size biopharmaceutical companies in developing innovative treatments for challenging therapeutic areas including oncology, neurology, rare diseases, infectious diseases, and metabolic disorders. Veristat's comprehensive services span the entire drug development lifecycle, from early-phase clinical trial design and execution to regulatory submissions and post-marketing support. The company has established a strong track record in biologics, gene therapies, and cell therapies, having supported the first gene therapy approved in Europe. Operating globally with offices across North America, Europe, and Asia, Veristat employs a team of scientific experts who combine bold thinking with practical execution to help clients navigate regulatory complexities and accelerate the delivery of life-changing therapies to patients in need.