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Sr. Clinical Documentation Associate

Position Summary:

The Sr. Clinical Documentation Associate is responsible for the creation, maintenance, review, and archiving of the electronic Trial Master Files (eTMFs) for Achaogen Sponsored clinical trials.  This individual will be serve as the primary point of contact for processes, systems and controls for eTMF, study-specific training documentation and other Good Clinical Practice (GCP)-related compliance documents.

 

Essential Functions:

  • Serves as the Development Operations resource to ensure that required documentation exists to support regulated activities, including serving as the documentation technical specialist for other development functions contributing documents to the electronic Trial Master File.
  • Responsible for contributing to process design, implementation and hands-on eTMF and GCP document activities that ensure quality documentation and system performance.
  • Proposes, implements and maintains appropriate control of the eTMF and manages aspects of vendor oversight that include necessary performance and quality metrics.
  • Serves as a single point of contact and subject matter expert during internal/external audits and regulatory inspections of the TMF and contributes to responses for relevant audit/inspections findings, and facilitates remediation of relevant CAPA commitments.
  • Partners with the study teams to develop eTMF Maps/Indexes and Filing Plans.
  • Manages TMF/eTMF migrations from CROs to in-house system and conversion of legacy TMFs to digital format.
  • Facilitates the creation of study-specific eTMFs during the study start-up phase.
  • Serves as the primary point of contact for study-specific eTMF questions.
  • Supports the study teams and eTMF Content Owners to ensure eTMF compliance with applicable Standard Operating Procedures (SOPs), regulations, ICH and GCP.
  • Creates and manages eTMF structure and repositories for clinical studies based on the Company and Industry standards. Facilitates the creation and implementation of necessary SOPs and/or process changes and ensures inspection readiness.
  • Manages access and organization of the eTMF, including ensuring the defined file structure is maintained.
  • Provides appropriate oversight across all contributors to the eTMF; partners with study teams to facilitate appropriate vendor oversight and quality control procedures throughout the lifecycle of a trial.
  • 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 standards.

 

Preferred Experience:

  • A minimum of 6 years’ Pharmaceutical biotechnology or medical device industry is required (preferably in Clinical Operations) with at least 3 years’ experience in Clinical eTMF management is required
  • Expertise with GCP, 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 eTMF.
  • Highly proficient with the technical aspects of eTMF system software.
  • Experienced in handling study essential documents and previous experience monitoring clinical trial sites required.
  • Strong interpersonal skills with a demonstrated ability to interact and influence with many levels and areas of technical and business staff.
  • Knowledge of eTMF systems preferred, specific knowledge of Veeva Vault is plus.
     

Preferred Education:

  • Bachelor's degree in a scientific discipline is required.  Equivalent experience may be accepted.  

Preferred Additional Skills:

  • Excellent teamwork and collaboration skills along with demonstrated ability to work in a cross-functional team and drive eTMF progress.
  • Proficient with Microsoft Office.
  • Flexibility and willingness to solve problems that fall outside of immediate area of expertise.
  • Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to detail.
  • Work independently in an interdisciplinary, fast-paced, often changing environment.
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
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