What are the responsibilities and job description for the Clinical Document Manager position at Lifelancer?
Job Description
Job Description
Job Title : Clinical Document Manager
Job Location : San Francisco, CA, USA
Job Location Type : Remote
Job Contract Type : Contract
Job Seniority Level : Mid-Senior level
Overview
We are currently searching for a skilled professional to join a well-known client’s team as a Clinical Document Manager remotely in the United States. The Clinical Document Manager role will ensure each Trial Master File can fully reconstruct the conduct of a clinical trial and those documents are readily available for audits / inspections. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
Responsibilities
- 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.
- 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.
Experience
Minimum of 8 years of experience in the pharmaceutical, biotechnology or medical device industry with at least 3 years' experience in Clinical Trial Master File management is required.
EDUCATION
Minimum of Bachelor’s Degree required. Equivalent experience may be accepted.
To Be a Best-fit Your Strengths Must Include
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http : / / www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
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Lifelancer ( https : / / lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
For more details and to find similar roles, please check out the below Lifelancer link.
https : / / lifelancer.com / jobs / view / ab53daecc3c99e0f338c7f3323306611
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