Are you a seasoned professional in clinical research with a passion for eClinical systems and Trial Master File (TMF) processes? We’re looking for an eClinical Systems Analyst to join our team and support clients with the development, maintenance, and closeout of clinical trials.
✅About the Role
As an eClinical Systems Analyst, you’ll work closely with Study Owners to ensure a complete, contemporaneous, and accurate TMF across clinical trials and programs. Your expertise in eClinical systems, including eTMF, Study Start-up (SSU), and Clinical Trial Management System (CTMS), will be essential in driving the success of our clients’ clinical trials.
✅Key Responsibilities:
Work with Study Owners on all start-up, maintenance, and close-out activities related to the TMF
Provide ongoing user management for eTMF systems
Create and maintain events/placeholders or equivalent in the eTMF system
Conduct quality reviews to ensure document content and metadata application are accurate
Communicate systematic filing issues to management for further training evaluation
Perform periodic quality reviews for each active study site
Draft, review, and approve TMF Quality plans and reports
Assist in regulatory document review and compilation of documents for FDA submissions
Identify and report on TMF trending issues/concerns, and determine resolutions and course of action
Provide support on metrics and report preparation for TMF Key Performance Indicators (KPIs)
✅Requirements:
Experience with eClinical systems, particularly TMF processes
Strong knowledge of clinical trial processes and associated systems
Excellent analytical and problem-solving skills
Ability to work independently and manage multiple projects simultaneously
Strong communication and interpersonal skills
✅What We Offer:
Opportunity to work with a leading provider of language services and solutions
Collaborative and dynamic work environment
Professional development and growth opportunities
Competitive salary and benefits package
✅Why Choose This Role?
As an eClinical Systems Analyst, you’ll have the opportunity to work on complex and challenging projects, develop your skills, and contribute to the success of clinical trials. You’ll work closely with cross-functional teams, including clinical research, regulatory affairs, and medical writing.
✅Tips for eClinical Systems Analysts:
Stay up-to-date with industry trends and eClinical systems
Develop strong analytical and problem-solving skills
Build relationships with cross-functional teams and stakeholders
Consider obtaining certifications, such as the Certified Clinical Research Professional (CCRP) certification
✅eClinical Systems Career Development
A career in eClinical systems offers a wide range of opportunities for growth and development. As an eClinical Systems Analyst, you’ll have the chance to develop your skills in clinical trial management, TMF processes, and eClinical systems.
✅Benefits of Working in eClinical Systems:
Opportunity to contribute to the success of clinical trials and the development of new treatments
Collaborative and dynamic work environment
Professional development and growth opportunities
Competitive salary and benefits package
📩 How to Apply
If you have experience in clinical research and expertise in eClinical systems and TMF processes, we’d love to hear from you!
👉 Apply Here:
🔗 https://www.linkedin.com/jobs/view/4311236727