Clinical Document Manager
455 Mission Bay Boulevard South San Francisco, CA 94158 US
- Ensure each Trial Master File can fully reconstruct the conduct of a clinical trial and those documents are readily available for audits/inspections.
- Ensure defined TMF file structure(s) are maintained and secure. Create new TMF structures when needed.
- Serve as the company's Veeva Vault eTMF technical specialist.
- Provide quality control reviews of key clinical documents (e.g., protocols and ICFs)
- Manage user access and organization of the company's TMF, archival repositories, and offsite storage location.
- Manage retention and destruction schedules for the company's maintained and offsite storage TMFs.
- Manage off-site archiving activities (including budget, cataloguing process, and document retrieval)
- Manage document index to ensure all on-site and off-site documents can easily be retrieved.
- Define, execute, and manage TMF system migrations and associated Quality Control processes.
- Define and manage necessary vendor oversight that includes performance and quality metrics, ensuring they meet ICH guidelines and global regulatory requirements. Ensure TMF metrics are reviewed and distributed.
- Propose and contribute to process design, implementation, and hands on TMF activities that ensure quality documentation and system maintenance.
- Support clinical trial managers and other contributors to ensure ongoing content management of the TMF.
- Ensure vendors perform to our document quality standards and expectations. Oversee CRO conducted TMF activities and file reviews.
- Partner with study teams to facilitate appropriate vendor oversight and quality control procedures throughout the lifecycle of a trial, including appropriate oversight for all contributors to the TMF.
- Perform periodic reviews of TMF to ensure adherence to standards and compliance with relevant regulations, guidelines, and standards.
- Plan and manage company oversight review of the CRO TMF, including tracking of all findings through closure.
- Manage the exchange of TMF documents with external service providers.
- Perform initial and/or in-process assessment of vendor standard operating procedures, and document the review as requested.
- Exercise judgment within generally defined practices and policies in selecting methods and techniques.
- Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
- Communicate critical issues, accomplishments, risks, and modifications of current procedures to Management.
- Maintain knowledge of industry standards to ensure adequacy of the TMF system and continuous process improvement.
- Conduct training, lead awareness efforts, and educate TMF contributors about process quality and compliance.
- May serve as a resource during internal/external audits and regulatory inspections of the TMF, as well as management and archiving of documents for relevant clinical development departments.
- May support or facilitate remediation of relevant CAPA commitments.
- Other duties as required.
- Bachelor's degree is required. Equivalent experience may be accepted.
- A minimum of 8 years pharmaceutical, biotechnology or medical device industry is required with at least 3 years' experience in Clinical Trial Master File management is required.
- Expertise with Good Clinical Practices (GCPs), International Conference for Harmonization (ICH) Standards, and FDA Code of Federal Regulations for clinical trials.
- Strong knowledge of global regulatory requirements and ICH/GCP guidelines.
- Knowledge of clinical research study design and ability answer technical questions related to tips, techniques and problem solving around TMF.
- Knowledge of multiple eTMF systems preferred. Specific knowledge of Veeva eTMF is huge plus. "White belt" certification preferred.
- Highly proficient with software capabilities and business applications.
- Experience in management of multiple global clinical trial programs is highly desired.
- Experienced in handling trial essential documents is required.
- Possesses demonstrated ability to supervise others, either directly or in a project matrix/oversight scenario.
- Strong interpersonal skills with a demonstrated ability to interact with many levels of technical and business staff.
- Excellent analytical, problem solving, and organizational skills are required.
- Ability to establish excellent internal and external relationships, including vendors.
- High level of flexibility and ability to adapt to changing conditions.
- Good oral and written communication and interpersonal skills.
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