- Title: Specialist Study Management
- Code: RCI-22904
- Location: Wilmington, DE 19850
- Posted Date: 06/23/2022
- Duration: 5 Months
Talk to our Recruiter
- Name:Rajgurusingh Azad
- Email: Rajgurusingh.firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 225
Ideal Candidate Profile:
- 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; thinks "outside the box"
- 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 - Candidates must be local to Wilmington, DE; non-remote position
- 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).
Skills and Competencies
- 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