TMF Manager, Contractor 2055320
Location:  Cambridge, MA (Hybrid)
Science:  Small Molecule
Job Overview:  This position manages and maintains the integrity of Trial Master Files (TMFs), oversees clinical document quality and filing, and provides guidance and training on eTMF systems in line with clinical trial conduct and documentation best practices.
Primary Job Responsibilities:

• Manage and ensure the quality and regulatory compliance of clinical documents and TMFs.

• Train and support CROs and internal teams on eTMF system best practices according to ICH GCP guidelines.

• Develop and maintain SOPs and training materials for eTMF platforms, enhancing cross-functional collaboration.

Primary Job Requirements:

• Bachelors in science/health or similar experience with a minimum of 5 years in e/TMF roles.

• Experienced with the DIA Reference Model and e/TMF filing requirements for various functions.

• Well-versed in ICH GCP and GDP principles, ensuring high-quality clinical document management.

• Experience with eTMF systems, including SOP development, user training, and system testing/validation.

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.
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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. 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 employeeservices@apexsystems.com or 844-463-6178.