Trial Master File (TMF) Manager
South San Francisco, CA | Contract
Bayside Solutions is seeking a Trial Master File (TMF) Manager to be part of our client’ s team in South San Francisco. This is an opportunity to work with one of the largest Biopharmaceutical companies in the world developing innovative medicine to save patients’ lives.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Trial Master File (TMF) Manager
The Trial Master File Manager is responsible for the archiving of all TMF related documents. As such this person plans and coordinates the overall management of the Trial Master Files for Roche and associated processes, including system and tool development, business process documentation and is ultimately responsible to ensure inspection readiness for the TMF.
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Manage the governance of the Trial Master Files across cross-functional teams
- Adhere to regulatory requirements and alignment of functional templates to individual functional documents
- Develop and maintain business processes
- Input into supporting system and tool development
- Input into TMP report development and business use
- Coordination of TMF training and support network
- Ensure and coordinate proactive support for inspection readiness
- Quality oversight across all TMF’ s
- Contribute to success through regular correspondence and meetings
- Manages KPIs and the assessment of performance
- Coordinate the creation of domain-specific processes
- Enable the recruitment and training of TCS associates
- Support identification and implementation risk management plans
- Support the domain specific steering committee operations
- Develop an environment which fosters a high-performance and innovative organization
- Coaching of staff in both functional and core competencies
- Ensure specific focus on talent management, ensuring continuous development and mentoring of all talents
- Ensure continuous training needs identified for succession and career development of staff
- Serve as a mentor and role model
- Collaborate with other business managers to leverage opportunities of job enrichment and development opportunities for staff.
Summary of Qualifications:
- A Bachelor’ s degree and a minimum 10 years’ experience in a clinical development function
- Previous experience in clinical processes and systems development and maintenance preferred
- A significant level of drug development expertise
- specifically clinical trial management expertise
- Good working knowledge of ICH/GCP, particularly in TMF Management
- Demonstrated ability to think strategically across the drug development process and associated departments
- Demonstrated ability to interact with all levels of customers and high proficiency in stakeholder management
- Excellent communication skills at all levels of the organization
- Proficient computer skills
- Demonstrated integrity, courage and passion
- Flexible attitude
- Ability to travel internationally up to 15% and work across different geographically located sites