Clinical Document Management With TMF

01 Jul 2024

Vacancy expired!

CLINICAL DOCUMENT MANAGEMENT WITH TMF WILMINGTON, DE Onsite. Project Description:

  • Own and maintain quality for the study file as the local study team TMF owner .
  • Responsible for site communications and other portal management .
  • Running and analyzing reports from multiple systems .
  • Responsible for Vendor Management .
  • Handle requests for CTMS updates .
  • Operational responsibility to set-up the local Trial Master File (eTMF) including tracking of documents.
  • Maintain and close the local TMF ensuring International Conference of Harmonization Guidelines for Good Clinical Practice (ICH/Google Cloud Platform) compliance and local requirements.
  • Support the CRA in the maintenance and close out activities for the ISF.
  • Contribute to the production and maintenance of study documents, ensuring template and version compliance.
  • Contribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities (not for international studies).
Required Skills:
  • Bachelor's degree is preferred .
  • 3-5 years of experience in clinical trials and regulatory documents is required .
  • Veeva experience a plus .
  • Accountable and inquisitive.
  • Must be methodical, compliant to processes yet flexible when needed .
  • High ability to manage priorities and Local Study Team expectations .
  • Independent yet able to work cohesively with a team .
  • Experience with electronic trial master file system(s) including uploading, reviewing, QC, approval of study required documents.
  • Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/Google Cloud Platform guidelines .
  • Working knowledge of clinical study documents .
  • Ability to develop advanced computer skills to increase efficiency in day-to-day tasks .
  • Good verbal and written communication .
  • Good interpersonal skills and ability to work in an international team environment .
  • Willingness and ability to train others on study administration procedures .
  • Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities .
  • Team oriented and flexible; ability to respond quickly to shifting demands and opportunities .
  • Integrity and high ethical standards .
This 6+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: ALPHA'S REQUIREMENT #22-01966 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

  • ID: #43744839
  • State: Delaware Wilmington 19850 Wilmington USA
  • City: Wilmington
  • Salary: BASED ON EXPERIENCE
  • Job type: Contract
  • Showed: 2022-07-01
  • Deadline: 2022-08-29
  • Category: Et cetera