Clinical Documentation Manager

San Francisco, CA, United States
Jun 19, 2018
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Summary:

Serves as a 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. Serves as a 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.


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. Oversee management of training documentation

* Ensure role based curricula for development operations departments are current

* Collaborate with leadership to assign training assignments based on role based curricula

* Ensure CVs and JDs for clinical R&D personnel are maintained in the electronic training system to support inspection-readiness initiatives

* Run periodic reports to evaluate training compliance and provide summaries to management

* Assist study teams in ensuring that team members, vendors and investigative site training in GCP and other compliance requirements is properly documented

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 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. Other duties as required.


Bachelors 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 eTMF systems preferred, specific knowledge of NextDocs eTMF processes is huge plus. Highly proficient with software capabilities and business applications Hands-on managerial/leadership experience required.
Experience in management of multiple global clinical trial programs is highly desired. Experienced in handling trial essential documents and performing site monitoring required. Track record of delivering process improvement projects. 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.