Job Category: Clinical Affairs
Job Number: 12124546
Akraya is looking for a Clinical Trials Manager for one of our award-winning clients. You will be a valuable member of an amazingly talented team that is driven by the fact that their projects are changing lives and improving the human condition. This company was recently named a “Company to Watch” by the Life Science Industry Awards. To be considered, please apply directly or call Vaibhav Kalbende at 408-512-2355. If this position is not quite what you’re looking for, visit akraya.com and submit a copy of your resume. We will get to work finding you a job that is a better match at one of our many amazing clients.
Primary Skills: clinical trial, Clinical research, FDA, EMA Regulations, ICH Guidelines, GCPs
Duration: 6+ Months (possible extension)
Tax Term: W2 Only
- Manage all aspects of clinical trial conduct including study start-up, enrollment, study conduct and close-out.
- Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines.
- The position will report to the Associate Director of Clinical Operations.
Please apply directly with your update resume or call Vaibhav Kalbende at 408-512-2355
- At least 5+ years of experience related clinical trial management and a BS or BA in a relevant scientific discipline.
- Clinical research knowledge and cross-functional understanding of clinical trial methodology.
- Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management.
- Attention to detail required.
- Thorough knowledge and understanding of FDA and/or EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required.
- Must be able to resolve problems using national and international regulations, guidelines and investigator interaction.
- Partners with functional peers to manage, adjust, and revise project timelines/budgets as necessary.
Akraya, Inc. is an award-winning staffing firm that works with many of the leading, technology-based companies around the world. We have been ranked as one of the “Best Staffing Firms to Temp for” by Staffing Industry Analysts on multiple occasions and are a preferred staffing vendor within numerous staffing programs. Please visit akraya.com to search through all of our current openings or to submit your resume to our recruiting team.