Associate Director, eTMF Management
Location
Foster, CA | United States
Job description
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare liver diseases affecting children and adults. Propelled by our passion for patients and their families, we’re focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies that are poised to positively impact the treatment of rare liver diseases. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. Learn more about our work, our culture, and what it’s like to be a part of our team: .
POSITION SUMMARY The Associate Director, eTMF Management is accountable for strategy and delivery of clinical document management (CDM) systems, processes, standards and operations of CDM services. The role will drive the transformation of TMF at Mirum, through the introduction and adoption of new technologies, processes and ways of working to deliver high quality and timely TMF Quality Review activities for a portfolio of Mirum studies.
JOB FUNCTION/RESPONSIBILITIES - Establishes and manages the quality oversight of the TMF including quality checks and TMF metrics and KPIs.
- Oversees staff (when necessary) and vendors to ensure all physical and electronic records, on-site and off-site are controlled and accurately catalogued and filed.
- Represents the TMF Team on key task forces related to records management.
- Supports the collaboration with service providers and CROs on TMF management including reviewing process, ensuring TMF completeness and managing the transfer of TMF records and needed.
- Supports and oversees the implementation of Veeva eTMF at Mirum.
- Contribute to the development and assist with the implementation of TMF specifications, such as process and system changes.
- Act as administrator/system owner of the Veeva Vault eTMF system, setting up and maintaining the system (with Mirum and CRO access).
- Oversee and manage eTMF migration activities of CRO eTMFs into Mirum’s eTMF.
- Conducts TMF planning by reviewing short- and long-term resources and space requirements to identify and evaluate possible options for on and off-site locations.
- Coordinate and oversee document management activities, including filing, QC, and archiving performed by third parties.
- Monitor and evaluate study requirements to ensure eTMF structure is deployed in conjunction with clinical trial launch.
- Ensure quality checks are performed as per SOPs/TMF plans and monitor progress in resolution of identified eTMF discrepancies.
- Ensure a contemporaneous TMF at all times in line with Inspection Readiness.
- In cooperation with Clinical Operations, lead and manage Inspection Readiness preparation of the TMF, TMF audits, mock inspections and regulatory inspections, and interact with auditors and inspectors to address queries.
- Ensure internal and external personnel are appropriately assigned eTMF user roles and permissions
• Track and maintain user access and eTMF permissions
• Develop and maintain TMF SOPs, work instructions, reference guides, naming conventions, and TMF Plans
• Develop and conduct TMF User training (internal and external) and train-the-trainer training sessions
• Establish and maintain user training materials for all user types
• Oversee and ensure documented training of internal and external TMF users
• Oversee management of vendors providing TMF services
• Manage TMF vendor contracts and budgets in collaboration with Clinical Project Managers and Finance - Accountable for the overall management of the Mirum TMF function, content and quality of the TMF, and proactively managing risks and issues.
- Actively identify continuous improvement opportunities through process and metrics analysis and apply lessons learned.
- When necessary, manages direct reports and establishes the goals and objectives to support the overall goals of Mirum.
- Support/Assist in Regulatory filings
QUALIFICATIONS Education/Experience:
- BS/BA in related discipline and 6-8 years of related experience; or, Equivalent combination of education and experience
- 6-8 years' working in a pharmaceutical or other highly-regulated corporate environment, with significant, and increasingly independent, interaction with the various functional units of the corporation to design and develop record-keeping systems, policies, and procedures
- 6 years' experience working in the Records Management field, including 4 years' experience using electronic records management systems, with progressive experience managing active, inactive, and archived records, analyzing business processes, and developing and implementing Records Management policy and procedures.
- People management experience with demonstrated experience in motivating teams, setting up goals, providing leadership and guidance as needed.
- Broad understanding of clinical document management processes within an international biotech/pharmaceutical company, and the ability to translate the records management needs of those business processes into clear and concise terminology, logical and hierarchical arrangements of records types and series, and clear and effective procedures for filing and managing clinical trial records.
Knowledge, Skills & Abilities:
- Expert experience in electronic Trial Master File requirements and set up.
- Advanced experience in the DIA Reference Model.
- A firm understanding of the clinical development lifecycle and the technologies associated with the activation and management of clinical trials and study sites.
- Strong understanding of study and site management and overall trial planning and execution.
- Strong knowledge of global regulatory requirements and ICH/GCP guidelines.
- Strong knowledge with electronic document management systems, document archival systems (eTMF) and CTMS system.
- Excellent attention to detail, strong critical thinking, and logical problem solving.
- Ability to proactively identify potential issues and formulate potential course(s) of action.
- Excellent organizational, time management and project management skills.
- Experience and comfort in working both independently and as part of a multifunctional team.
- Proven organizational skills and strong ability to prioritize workload.
- Commitment and ability to handle high workloads, demanding situations, and deadlines.
- Ability to interact and communicate effectively, both verbally and written, with colleagues and management, both within and outside clinical operations, including upper management, vendor personnel, and clinical investigators and site personnel.
- Able to work autonomously and with a team.
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Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
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