What are the responsibilities and job description for the Clinical Document Manager position at Compass Consulting?
Our client is a clinical-stage biopharma company developing a pipeline of drug candidates which are designed to improve the benefits of drugs for patients.
Duties : TMF Management
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 Veeva Vault eTMF technical specialist.
Provide quality control reviews of key clinical documents (e.g., protocols and ICFs)
Manage user access and organization of TMF, archival repositories, and offsite storage location.
Manage retention and destruction schedules of 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.
CRO Oversight
Support clinical trial managers and other Company 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 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.
Skills :
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.
Education :
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.
Specific knowledge of Veeva eTMF is required. "White belt" certification preferred. Knowledge of multiple eTMF systems 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.
Salary : $50 - $55
