Head of Clinical Data Management for Trials

Accenttx; Lexington (MA); On-site; USD 100,000 - 140,000; Full time

Job summary

A biopharmaceutical company in Lexington seeks a Director of Clinical Data Management. This role is pivotal for overseeing all data management activities in clinical trials, ensuring data integrity, completeness, and compliance with regulations. Candidates should have a Bachelor's degree in health sciences or a related field and 5 years of experience in clinical data management. Strong expertise in regulatory requirements and data management tools is essential for success in this role.

Qualifications

• 5+ years of progressive clinical data management experience in pharmaceutical or biotechnology environments.
• Experience with GCP, CDISC requirements, ICH, and FDA regulations.
• Hands-on experience with web-based Electronic Data Capture systems.

Responsibilities

• Lead data management activities across clinical trials.
• Ensure integrity and compliance of clinical trial data.
• Oversee CROs and monitor performance metrics.

Skills

Clinical trial processes

Data management principles

Regulatory requirements

Strong communication skills

Analytical abilities

Education

Bachelor’s degree in health sciences or related field

Advanced degree in a related field

Tools

EDC systems

SQL

SAS

R

Python

Job description

A biopharmaceutical company in Lexington seeks a Director of Clinical Data Management. This role is pivotal for overseeing all data management activities in clinical trials, ensuring data integrity, completeness, and compliance with regulations. Candidates should have a Bachelor's degree in health sciences or a related field and 5 years of experience in clinical data management. Strong expertise in regulatory requirements and data management tools is essential for success in this role.