Clinical Trial Document Management With TMF
Company: Alpha Consulting Corp.
Posted on: September 25, 2022
CLINICAL TRIAL 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 Harmonisation Guidelines for Good Clinical Practice
(ICH/GCP) 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/GCP 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 3+month position starts
ASAP. Please E-MAIL your resume (attachment to email) with rate and
availability to Bridget: email@example.com ALPHA'S
REQUIREMENT #22-02565 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN
HOURLY W2 EMPLOYEE
Keywords: Alpha Consulting Corp., Wilmington , Clinical Trial Document Management With TMF, Healthcare , Wilmington, Delaware
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