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Title: Clinical Documentation Manager
Hiring Organization: Connexion Systems & Engineering
Our client is seeking: Clinical Documentation Manager
Duties: Implements cross-functional business processes, and manages systems to ensure 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.
Compensation, Benefits, and Employment Type
- Duration – Contract
- Pay rate: 65-69/hr.
- Job Location: Sunnyvale, CA
- Job# bh11444
- Date Posted: 6/10/2020
Assists in access and organization of the controlled clinical document storage on-site, including ensuring the defined file structure is maintained. Assists in 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.
Assists in the document preparation room during regulatory inspections. Assists in retention and destruction schedules for TMFs. Assists in off-site archiving activities (including budget, cataloguing process, and document retrieval). Assists in 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. 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
Skills: As requested, provides quality control reviews of TMF related documents. 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
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 ensure system are in keeping with industry standard. Responsible for the performance management and development of Document Specialists. Other duties as required.
Education: 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. Knowledge with Good Clinical Practices (GCPs), International Conference for Harmonization (ICH) Standards, and FDA Code of Federal Regulations for clinical trials. 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 Veeva Vault 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.
Skills and Experience:
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