Principal Clinical Data Manager

About the role

The Principal Clinical Data Manager works independently and with management to perform data management tasks from study start‑up through database lock for clinical research projects, overseeing mid‑to‑large complex studies, leading a team of CDMs, and promoting consistent operations and knowledge sharing.

Responsibilities

• Perform data management tasks from study start‑up through database lock for paper‑based and electronic data capture (EDC) studies.
• Ensure overall data quality and documentation on clinical research projects.
• Work on mid‑to‑large complex projects across various indications, at times serving as program manager overseeing multiple studies for the same client.
• Lead a team of CDMs to ensure contracted activities follow Veristat and/or sponsor SOPs.
• Promote consistent operations, efficient resource use, and sharing of knowledge and best practices with Data Management leadership.
• Assist with training of other data managers on project‑specific and general data management processes, procedures, and systems.
• Provide training to other company functions 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.

Qualifications

• 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 the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotech companies.

Skills

• Demonstrated ability to lead by example and provide technical leadership of staff.
• Demonstrated ability to serve as a strong internal and external consultant, influence without authority, and guide project teams to mutually acceptable outcomes.
• Demonstrated ability to operate with the “big picture” in mind and serve as a thought partner to management.
• Expert level skills in use of computer technology, including clinical trial databases and applications (e.g., IBM Clinical Development, Medidata RaveX), with strong desire and ability to learn new applications.
• 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 a team mentor, providing data management expertise.

Benefits

• Remote working
• Flexible time off
• Paid holidays
• Medical insurance
• Tuition reimbursement
• Retirement plans

Pay

The estimated hiring range for this role is $114K – 150K plus applicable bonus. Final salary is determined based on skills, experience, licensure, certifications, education, location, and market data.