Principal Clinical Data Manager

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Execute data management tasks from the initiation of studies through the database lock for assigned clinical research projects.

• Oversee both paper-based and electronic data capture (EDC) studies.

• Ensure the overall quality of data and proper documentation for clinical research projects.

• Engage in mid-to-large scale complex projects across various indications.

• Occasionally act as a program manager supervising multiple studies for a single client.

• Lead a team of clinical data managers to ensure that contracted activities adhere to Veristat Standard Operating Procedures and/or sponsor-specific requirements.

• Foster consistent operations, effective resource utilization, knowledge sharing, and best practices with Data Management leadership.

• Support the training of data managers on both project-specific and general data management processes, procedures, and systems.

• Provide training for other company functions as required.

⛳️ Requirements

• Bachelor’s degree in a relevant field with a minimum of 7 years of applicable experience.

• At least 5 years of experience in clinical data management within a clinical research environment.

• 4 years of experience in leading project teams.

• Comprehensive knowledge of ICH Good Clinical Practice (GCP) guidelines and other relevant regulatory rules and guidelines.

• Familiarity with medical terminology, clinical trials, and the clinical research field.

• Working knowledge of CRO industry relationships and regulatory responsibilities with pharmaceutical/biotech companies.

• Proven technical leadership and the ability to lead by example.

• Capability to serve as both an internal and external consultant and to influence without direct authority.

• Ability to maintain a "big picture" perspective and provide guidance to management.

• Expert-level computer proficiency, including experience with clinical trial databases and applications such as IBM Clinical Development and Medidata RaveX.

• Strong motivation and capacity to learn new applications.

• Detailed understanding of project planning and management methodologies.

• Excellent interpersonal, communication, and organizational skills.

• Ability to work independently as well as collaboratively within a team environment.

• Competence to navigate multiple projects with varying priorities, mentor teams, and offer data management expertise.

🏝️ Benefits

• Remote working options.

• Flexible time off policy.

• Paid holiday time.

• Medical insurance coverage.

• Tuition reimbursement opportunities.

• Retirement plan options.

• Potential for bonuses.