Associate Director of Clinical Data Management

Thermo Fisher Scientific

392d • Remote

About The Position

The Associate Director of Clinical Data Management at Thermo Fisher Scientific is responsible for overseeing the Clinical Data Management (CDM) team, ensuring that data management processes align with the company's strategic objectives. This role involves managing data managers, refining data management processes, and ensuring compliance with documentation standards. The position requires strong leadership skills, expertise in electronic data capture (EDC) systems, and a solid understanding of clinical research regulations.

Requirements

• Bachelor's degree preferred, High school diploma required.
• 7 or more years' experience within Clinical Data Management in biopharmaceutical/biotech, or CRO setting.
• 3 or more years' in a supervisory or leadership role.
• Proven ability in core DM activities, processes, and documentation.
• Excellent communication skills to support effective interactions.
• Extreme attention to detail and ability to multitask with strong prioritization, planning, and organization skills.
• Advanced proficiency in Microsoft Office Suite.
• Prior experience in the pharmaceutical, biotechnology, medical device/diagnostic, or clinical trial industries.
• Strong knowledge of FDA Title 21 CFR Part 11.

Nice To Haves

• Dedication to process improvement while producing high quality work within required timelines.
• Strong English communication and writing skills.

Responsibilities

• Supervise and lead data managers and activities supporting CorEvitas' clinical registries from start-up through each revision cycle.
• Compile and manage CDM documentation to ensure master files are up-to-date and audit ready.
• Participate in design and/or review of new/revised forms.
• Oversee new EDC builds, mid-study updates, and/or fixes.
• Represent CDM in meetings with internal cross-functional teams.
• Collaborate with cross-functional individuals from various departments in support of registry deliverables.
• Contribute to project budget, resource planning, tracking CDM metrics/milestones, and ensuring data quality.
• Manage direct staff's training compliance, performance evaluations, goal setting, and career development.
• Collaborate with Director CDM on department growth, goals, processes, and support several department initiatives.
• Participate in and/or contribute to Subscriber and/or Regulatory audits and/or inspections.

Benefits

• Meaningful work that makes a positive impact on a global scale.
• Resources needed to achieve individual career goals.
• Opportunities for career development and growth.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: High school or GED
• Number of Employees: 10,001+ employees