Tmf Manager

Actalent • Cambridge, MA

407d • $135,200 - $187,200 • Hybrid

About The Position

The eTMF Manager at Actalent is responsible for overseeing the electronic Trial Master File (eTMF) systems, ensuring compliance with industry standards, and managing related tasks to support project goals. This role requires a proactive individual with strong communication skills and the ability to thrive in a dynamic, fast-paced environment.

Requirements

• 5 years of eTMF experience within a pharmaceutical, biotechnology company, or contract research organization.
• Thorough knowledge of electronic TMF applications for major non-proprietary systems.
• Experience with eTMF systems including development of SOPs, user training manuals, UATs, and validations.
• Strong understanding of the DIA Reference Model and eTMF filing requirements.
• Proficiency in developing and delivering educational materials, both written and oral.
• Excellent communication and public speaking skills.
• Strong interpersonal and organizational skills with a high degree of attention to detail.
• Global trial experience.

Nice To Haves

• Bachelor's degree in a related field.
• Knowledge of documents from various functional areas and their appropriate eTMF filing requirements.
• Ability to engage in cross-functional interactions with internal and external staff.

Responsibilities

• Develop and manage SOPs for eTMF systems.
• Create and deliver user training manuals.
• Perform User Acceptance Testing (UATs) and validations for eTMF systems.
• Prioritize eTMF-related tasks based on project goals.
• Engage in cross-functional interactions with internal and external staff.
• Ensure compliance with the DIA Reference Model and eTMF filing requirements.
• Maintain thorough knowledge of ICH Good Clinical Practice (GCP) and Good Documentation Practice (GDP) principles.

Benefits

• Commuter assistance
• Health savings account
• AD&D insurance
• Disability insurance
• Health insurance
• Dental insurance
• Paid time off
• Employee assistance program
• Vision insurance
• Life insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree
• Number of Employees: 10,001+ employees