Clinical Document Control Specialist

Location: Irvine, CA, United States
Date Posted: 07-28-2018
or
Company: Client of The Griffin Groupe Executive Search
Location: Irvine, CA
Job Type: Contract
Duration: 6-12 Months
Industry: Pharmaceutical
Rate: Market
 
Trial Master File Specialist Consultant
 
The Griffin Groupe is searching for a talented document control expert for a valued client in the Pharmaceutical industry. This is an opportunity to work with a company that is in the process of developing and researching novel cancer drugs.
 
JOB DESCRIPTION
 
Responsible for developing a Trial Master File (TMF) system to catalog existing clinical trial data. Successfully and proactively manage study-specific Trial Master Files (TMF), both electronic and paper in format. Responsibilities include creating and maintaining TMF governance documentation, performing quality reviews of TMFs for completeness, performing record review for accuracy and quality. Will work in collaboration with the Quality Assurance department to achieve TMFs that are in an ongoing state of inspection readiness.
 
RESPONSIBILITIES
 
  • Ensure adherence to client’s standards (policies and SOPs/WIs), and all applicable regulations and guidelines (for example FDA regulations and ICH GCP guidelines) across the management of TMFs
  • Lead TMF stakeholders in the identification and mitigation of TMF inventory gaps and other TMF related issues for all assigned studies/ programs
  • Identify, track, and review TMF content across multiple studies/ programs
  • Work with multi-functional study teams to ensure the maintenance of TMFs, both electronic and paper, in a state of inspection readiness
  • Create and maintain study-specific TMF Management Plan and indices
  • Support the functional owners in the identification and management of the collection of study specific TMF content, (where client owned, and when delegated to vendor and/or CRO)
  • Performs independently; day to day quality check of TMF content and accuracy of coding
  • Acting TMF subject matter expert (SME)/ point of contact for study teams and TMF stakeholders
  • Produce and manage site/ study/ business level TMF reports and metrics provide to study teams who us the eTMF as the repository of their TMF records
  • Manage and reconcile TMF records across multiple record management databases
  • Perform inventory activities for off-site storage records
  • Provide input on the revision of TMF related Work Instructions and SOPs
  • Provide support and TMF guidance in audits and/ or inspections
 
REQUIRED QUALIFICATIONS
  • 2-4 years of Clinical Research Associate (CRA) or higher equivalent experience
  • 1 plus years of relevant records management/ TMF management experience
  • Comprehensive understanding of the clinical study phases involved in drug development and their corresponding records requirements
  • Knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and FDA GCP guidelines related to Clinical Document Management
  • Demonstrated ability to apply clinical operations knowledge in the use of Clinical Information Systems
  • Ability to collaborate with study teams to establish and determine their technical, functional requirements and performance requirements
  • BA/ BS required
  • Relevant certifications (such as CCRA) are a plus
Thomas Schortmann
Managing Partner
774-773-9321 x302
thegriffingroupe.com
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