Job Description We are seeking a motivated and experienced eTMF Manager to join our team. The ideal candidate will have a thorough knowledge of electronic Trial Master File (eTMF) applications and the ability to prioritize related tasks based on project goals. This role requires a creative problem solver with excellent communication and public speaking skills, capable of flourishing in a fast-paced, small company environment. 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 International Council for Harmonization (ICH) Good Clinical Practice (GCP) and Good Documentation Practice (GDP) principles. Essential Skills + 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. Additional Skills & Qualifications + 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. Pay and Benefits The pay range for this position is $65.00 - $90.00 • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Cambridge,MA. Application Deadline This position will be accepting applications until Dec 23, 2024. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.