Systems Consultant/Engineering Manager jobs in Lowell, MA

Job#: 2019498

Job Description:

TMF Manager 2019498
Location: Watertown, MA (Remote)
Science: Small Molecule
Therapeutic Area: Oncology
Job Overview: This role will be responsible for supporting the study management team with TMF process development, process implementation, and oversight of TMF management, working closely with the SMT Functional Area Leads and the Quality team to ensure smooth operations within the Clinical Operations department.
Primary Job Responsibilities:

• Act as the primary TMF contact and Subject Matter Expert (SME), supporting the clinical study team and cross-functional departments in TMF process education for an inspection-ready eTMF.
• Lead the development of SOPs, TMF-related plans, and system configurations, implementing process improvements and creating training tools.
• Maintain complete oversight of eTMF document filing, ensuring accuracy and compliance with company standards, Good Clinical Documentation Practices, and project-level Trial Master File Plan and Index.

Primary Job Requirements:

• Bachelors Degree and at least 5 years of clinical experience, including successful oversight and management of electronic Trial Master Files for clinical trials.
• Demonstrate a high level of competence with Veeva VAULT eTMF and an in-depth knowledge of the TMF Reference Model as supported by DIA, with experience managing multiple TMFs with consistent quality and compliance with TMF regulations.
• Experience in TMF-related SOPs, templates, plans, and tools
• Google Cloud Platform inspection experience

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.