Clinical Document Control Specialist - Contractor

Location
Berkeley, CA, US
Posted
Jul 12, 2018
Ref
1-18-066T
Hotbed
Biotech Bay
Required Education
Other
Position Type
Full time
Overview

Maintain Trial Master Files (TMFs) for all studies in compliance with appropriate US and international regulations as well as internal policies. Maintain a functional and orderly clinical document room to ensure effective and efficient storage, retrieval, and maintenance of TMFs and other related documents maintained in the clinical document room.
This position may participate in process improvements of standard operating procedures (SOPs), internal procedures and forms.
This position may include duties acting as the Clinical Training Coordinator Clinical, Regulatory, Safety, Data Management, Procurement/Contracts and Budgets, and Medical Writing

Responsibilities

    • Clinical Training Coordinator Responsibilities
      • Train Clinical and Regulatory Personnel and provide technical support for Clinical LMS system.
      • LMS System Admin for Clinical and Regulatory affairs
      • Develop SOPs and reports for Clinical and Regulatory affairs for management review.
      • Maintain training files for Clinical Development and Regulatory Affairs (including Clinical Operations, Drug Safety, and Biometrics).
      • Create and maintain training file for each employee in Clinical Development and Regulatory Affairs.
      • Monitor changes in department - new hires, title changes, and promotions- and ensure training file is updated in a timely manner.

    • Maintain TMFs for assigned studies:
      • Create and maintain TMFs.
      • Receive and conduct quality-control check on TMF documents.
      • Review the transfer information of all submitted documents.
      • Ensure accurate and consistent filing system of TMF documents.
      • Maintain accurate and current tracking systems - forms, logs, binders, etc.
      • Provide status reports on TMFs at project meetings and as requested.

    • Maintain electronic master files:
      • Organize and route documents and controlled copies electronically.
      • Conduct quality control and verification in eTMF ensure correct attachment.
    • May train and coordinate work of junior level staff.
    • Supports the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration, and teamwork.
    • Other duties as assigned.


Qualifications

  • The Specialist will have at least 5 years' direct experience with Trial Master Files in the biopharmaceutical or pharmaceutical industries. The Senior Specialist will have 8+ years' direct experience.
  • Must possess excellent organizational skills, follow-through, and great attention to detail.
  • Must be able to follow standard operating procedures and effectively triage when deviations from procedures occur.
  • Excellent oral and written communication skills. Must be able to communicate effectively with members of other departments and with study-site personnel (physicians, study coordinators, nurses, etc.) as needed.
  • Must be advanced with computer applications such as Word, Excel, eTMF, LMS, and PowerPoint, and possess the ability to learn other applications with appropriate training.


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