Associate Director, Trial Master File

About the role

As the Associate Director of Trial Master File (TMF) at Bamboohr, you will play a pivotal role in overseeing the management and integrity of trial master files for our clinical studies. This position is essential for ensuring compliance with regulatory standards and maintaining the highest quality of documentation throughout the clinical trial process. You will collaborate closely with cross-functional teams, including clinical operations, regulatory affairs, and quality assurance, to facilitate the smooth execution of clinical trials. Your expertise will help drive the success of our innovative therapies in the biotechnology sector.

Key facts

What you'll do

• Lead the strategic development and implementation of TMF processes and systems, ensuring alignment with industry standards and regulatory requirements.
• Oversee the creation, maintenance, and quality control of TMF documentation throughout the lifecycle of clinical trials.
• Collaborate with clinical project teams to ensure timely and accurate documentation of trial activities and results.
• Conduct regular audits of TMF to ensure completeness, accuracy, and compliance with applicable regulations and guidelines.
• Provide training and support to team members on TMF best practices and regulatory requirements.
• Serve as the primary point of contact for TMF-related inquiries from internal stakeholders and external partners.
• Develop and implement metrics to assess the quality and efficiency of TMF processes, identifying areas for improvement.
• Participate in regulatory inspections and audits, ensuring that all TMF documentation is readily available and in compliance with regulatory standards.
• Work closely with IT and data management teams to ensure that TMF systems are effectively integrated with other clinical trial management systems.
• Facilitate the timely submission of TMF documentation to regulatory authorities as required.
• Stay current with industry trends and regulatory changes related to clinical trial documentation and TMF management.
• Contribute to the development of standard operating procedures (SOPs) related to TMF processes and documentation practices.

Requirements

• Bachelor's degree in life sciences, healthcare, or a related field; advanced degree preferred.
• A minimum of 7 years of experience in clinical trial management, with at least 3 years in a leadership role focused on TMF or document management.
• In-depth knowledge of regulatory requirements and guidelines related to clinical trial documentation, including ICH-GCP and FDA regulations.
• Proven experience in managing TMF systems and processes, with a strong understanding of electronic TMF (eTMF) solutions.
• Excellent organizational skills with a keen attention to detail and the ability to manage multiple projects simultaneously.
• Strong communication skills, both written and verbal, with the ability to effectively collaborate with cross-functional teams.
• Demonstrated leadership abilities, with experience in mentoring and developing team members.

Nice to have

• Certification in clinical research (e.g., ACRP, SOCRA) is a plus.
• Familiarity with data management systems and clinical trial management software.
• Experience in a biotechnology or pharmaceutical company, particularly in a start-up environment.
• Knowledge of risk management principles as they relate to clinical trials.

Skills & tools

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and project management tools.
• Experience with electronic document management systems (EDMS) and TMF software.
• Strong analytical skills for assessing TMF quality and compliance metrics.
• Familiarity with regulatory submission processes and documentation requirements.

Practical notes

• This position is based in South San Francisco, California, and may require occasional travel to clinical sites or partner organizations.
• The role may involve working extended hours during critical project phases or regulatory submissions.
• Bamboohr is committed to fostering a diverse and inclusive workplace, and we encourage applications from candidates of all backgrounds.
• Interested candidates can apply directly through our careers page at [Bamboohr Careers](https://structuretx.bamboohr.com/careers/441).

Join us at Bamboohr, where your expertise in trial master file management will contribute to the advancement of groundbreaking therapies that can change lives. We look forward to your application!