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Associate Director, TMF

3 months ago

Waltham, United States Planet Pharma Full time

LOCAL CANDIDATES ONLY, PLEASE. This position will be hybrid in Waltham, MA - 3 days per week onsite.

Open to AD to Director level. This is a direct-hire (permanent) role with our client, a Biotech sponsor company. This will be the first person in the TMF department and will drive TMF strategy, processes, vendor management and Inspection readiness.

Candidates must be local, have extensive hands-on experience in TMF, have strong vendor management experience, and have previous experience in Inspection Readiness and Audits.

Job Description: Reporting to the Vice President of Clinical Operations, the Trial Master File (TMF) Associate Director / Director serves a key role, working across the organization for the execution of TMF Operations processes and strategy. The TMF Associate Director/ Director will provide tactical support and strategic guidance on TMF processes, filing conventions, index creation, maintenance, and other TMF related matters. The TMF Associate Director/Director will ensure compliance with applicable regulatory requirements. The TMF Associate Director/ Director will play a pivotal role in creating and maintaining consistency across studies and programs to ensure essential trial documents are appropriately collected, indexed, stored and accessible, while adhering to regulatory standards. As required, you will also proactively drive (i.e., hands-on involvement) and conduct TMF remediation efforts, inspection readiness activities, audits, and inspections.

Essential Job Functions: • Provide a robust framework to evaluate the overall health of the TMF, ensuring quality, completeness, and timeliness in the TMF for sponsored clinical trials. • Implement and maintain TMF quality control processes that are aligned to internal standards, regulatory requirements, and GCP. • Ensure TMF project documentation is maintained to the highest level of quality, accuracy, completeness, and compliance with regulations. • Lead and/or support TMF creation and/or TMF system implementation and configuration including the development of TMF management plan(s). • Lead and/or support TMF maintenance, closure, transfer, migration, and integration activities per company and/ or CRO SOPs and standards. • Ensure accuracy, completeness, and quality of TMF content by driving, overseeing, and facilitating regular reviews and audits. Ensure all documentation activities are conducted in compliance with GCP, relevant SOPs, and regulatory requirements and meet appropriate quality standards. • Drive and lead the development of metrics to assess the completeness and quality of the TMF and effectively communicate status updates to the study team and department management. Work with external partners and study team to address gaps, issues and mitigate risks. • Build collaborative relationships with CROs; drive the timely filing of documents throughout the study cycle; provide process and/or tactical support for TMF-related remediation as needed. • Collaborate with and support the study team in defining and maintaining expected study documents throughout the study cycle, including ensuring appropriate maintenance of expected documents in the TMF. • Serve as the SME for TMF during inspections and audits; collaborate with teams and regulatory authorities on TMF-related inquiries and inspections. • Develop and implement TMF training processes and provide guidance to the study team and cross-functional stakeholders on TMF expectations, tools, procedures and compliance requirements.

Required • Bachelor's degree in a clinical, scientific, or related discipline. • 8+ years demonstrated experience in industry with 4+ years in TMF experience including experience in study start-up, maintenance, and closeout, and performing quality and completeness reviews. • Proven track record of driving effective TMF-related initiatives. • Extensive knowledge and expertise in applicable regulations, guidelines, and industry best practices related to TMF management. • Expertise in clinical trial documentation and TMF Reference Model filing structure and proficient in eTMF systems or other Electronic Document Management System (familiarity with the Kivo system is a plus) • Strong knowledge of regulatory guidelines (e.g., ICH-GCP, FDA, EMA) pertaining to TMF. • Strong communication and problem-solving skills with the ability to provide solutions. • Ability to prioritize tasks and manage time effectively. • Excellent interpersonal skills and able to work in a matrix environment both internally and externally; can foster relationships. • Proven ability to lead and drive collaboration in a fast-paced, cross-functional team environment. • Demonstrated effective oral and written communication. • Experience with collaborating with clinical vendors/CROs. • Demonstrated ability to work independently as well as in a team environment.

Cultural Fit: Our culture is collaborative, one where people enjoy coming to work. We are a small, entrepreneurial company where everyone pitches in and works together to do whatever it takes to get things done. Our team is passionate, enthusiastic, and committed. We have a fast-paced, high accountability environment. We have a flat organization, and our leaders lead through influence and interpersonal skills, not command and control. Everyone on the team, including our CEO, is an individual contributor. We seek an individual for this position who shares our values and our enthusiasm about bringing new medicines to the patients and families that need them. We seek someone who will enjoy working in a small company environment and be motivated by the opportunity to directly influence and help shape the future direction and culture of our company.

Salary Range, Roughly: Director: $200K+ 22% Bonus Associate Director: $175K + 20% bonus

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