Clinical Documentation Manager
We are currently seeking a highly motivated Clinical Documentation Manager for our San Francisco office. This individual will be responsible for managing the Clinical Documentation team and serves as a primary point of contact for processes, systems and controls for Standard Operating Procedures (SOPs), Trial Master Files (TMF), training documentation and other GCP-related compliance documents.
The successful candidate will be responsible for the following:
Serves as the Development Operations resource to ensure required documentation exists to support regulated activities, including serving as the documentation technical specialist for other development functions contributing documents to the Trial Master File. Responsible for contributing to process design, implementation and hands on SOP, TMF and GCP document activities that ensure quality documentation and system performance. Proposes, implements and maintains appropriate control of the SOPs, TMF and manages necessary vendor oversight that includes performance and quality metrics. Contributes to responses for relevant audit/inspections findings and facilitate remediation of relevant CAPA commitments. This job contributes to and supports the company s research and development efforts to create high value therapeutics to address unmet medical needs.
Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques.
Serves 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. This role will also serve to ensure that vendors perform to our document quality standards and expectations, and may require on-site reviews at the location where the vendor holds the files.
Manages TMF performance objectives for end-to-end TMF process ensuring it meets ICH guidelines and global regulatory requirements. Accountability for managing Trial Master File system alignment across all functions within a matrix environment. Serves as technical specialist of the TMF portion of the electronic document management system. Implements cross-functional business processes, and manages systems to insure the highest level of quality is maintained and continuous improvement processes are applied.
Creates and manages TMF structure and repositories for clinical studies based on the Company standards. Facilitates the creation and implementation of necessary SOP and/or process changes and ensures inspection readiness.
Manages access and organization of the controlled clinical document storage on-site at Nektar, including ensuring the defined file structure is maintained.
Manages the exchange of TMF documents with external service providers. Supports clinical trial managers and other relevant contributors to ensure ongoing content management of TMF. Perform periodic reviews of Trial Master Files to ensure adherence to standards and compliance with relevant regulations and guidelines.
Provides assistance during internal/external audits of the TMF. Works with Management and the TMF team to insure that TMF is able to fully reconstruct the conduct of a clinical trial and that documents are readily available for audits/inspections.
Implements appropriate oversight across all contributors to the TMF; partners with study teams to facilitate appropriate vendor oversight and quality control procedures throughout the lifecycle of a trial. Assists in the document preparation room during regulatory inspections. Manages retention and destruction schedules for TMFs. Manages off-site archiving activities (including budget, cataloguing process, and document retrieval). Manages document index to ensure all on-site and off-site documents can easily be retrieved. Maintains knowledge of industry standards to ensure adequacy of the TMF system and continuous process improvement. Conducts training, lead awareness efforts, and educate TMF team and contributors about process quality and compliance.
Standard Operating Procedures. Participate in development and/or revision SOPs to ensure they remain current and reflect regulatory and business requirements. Perform initial and/or in-process assessment (on-site or remotely, when available & appropriate) of vendors standard operating procedures, and documents the review. Clinical Document Quality Control. As requested, provides quality control reviews of key clinical documents (e.g. protocols and ICFs). Review documents across a given development program for consistency (e.g., monitoring and data management plans compared with the protocol or SOPs). Review sampling of relevant study documents (e.g. monitoring reports, monitoring plans, data review plans) to assure adequate management of quality standards and risks are being employed. Manage compliance with clinical study registration and results postings for clinicaltrials.gov and other global posting requirements.
Collates, reviews and assesses with Management metrics (i.e., risk, quality defects, speed, cost) by which each process will be assessed and implements measures to improve processes or intervene as needed.
Communicates critical issues, accomplishments, risks and modifications of current procedures to Management. Actively gathers and maintains knowledge on external industry best practices to insure system are in keeping with industry standard.
Responsible for the performance management and development of Document Specialists.