Clinical Document Manager

Location
San Francisco, CA, United States
Posted
Jan 11, 2021
Ref
5280-530-R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for a Clinical Document Manager to join their team.

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, training, 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 study team TMF performance objectives for end-to-end TMF process ensuring it meets ICH guidelines and global regulatory requirements. Implements cross-functional business processes and manages systems to ensure the highest level of quality is maintained and continuous improvement processes are applied.

  • Manages TMF structure, Study-specific governance documents, TMF quality reviews and repositories for clinical studies based on Nektar standards.
  • 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 Lead and other relevant TMF contributors to ensure ongoing content management of TMF
  • Manages periodic quality reviews of Trial Master Files to ensure inspection readiness and 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 ensure that TMF can 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
  • Facilitates training, lead awareness efforts, and educate TMF team and contributors about process quality and compliance.
  • Oversee management of TMF training documentation
  • Run and maintain periodic metrics reports to evaluate compliance and provide summaries to management
  • Assist study teams in ensuring that team members, vendors and investigative sites maintain an inspection ready TMF
Standard Operating Procedures
  • Participate in development and/or revision SOPs and TMF management tools 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
  • Manages the quality control reviews of TMF related documents in conjunction with the study team and/ or CRO(s)
  • 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
  • Performs quality reviews of individual TMF documents in the Nektar eTMF and/ or paper files
Communicates critical TMF related issues, accomplishments, risks and modifications of current procedures to Management. Actively gathers and maintains knowledge on external industry best practices to ensure system are in keeping with industry standard. Responsible for the performance management and development of Document Specialists. Other duties as required.

Bachelors degree is required. Equivalent experience may be accepted. A minimum of 8 years pharmaceutical biotechnology or medical device industry experience is required with at least 3 years experience in Clinical Trial Master File management. Knowledge of standards and FDA Code of Federal Regulations for clinical trials. Knowledge of global regulatory requirements and ICH/GCP guidelines. Knowledge of clinical trial study design and the ability to answer technical questions related to tips, techniques and problem solving around TMF. Knowledge of Veeva Vault eTMF systems preferred. Highly proficient with software capabilities and business applications. Hands-on managerial/leadership experience preferred. Experience in management of multiple global clinical trial programs is highly desired. Experienced in handling trial essential documents required. Possesses demonstrated ability to supervise others, either directly or in a project matrix scenario. Strong interpersonal skills with a demonstrated ability to interact and influence 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.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.