SPECIALIST STUDY MANAGEMENT WITH CLINICAL TRIALS WILMINGTON, DE Hybrid (MUST be able to work in the Wilmington office a minimum of 3 days per week).
Project Description:
It is 25% document management and the manager is looking for someone that will:
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/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 .
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 .
Veeva experience a plus .
Accountable and inquisitive, thinks " outside the box " .
This 12+month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-00531
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
