Job Category: Clinical Affairs
Job Number: 11852136
Akraya is looking for a Clinical Trials Manager for one of our leading clients. To be considered, please apply or call Vaibhav at 408-512-2355.
We are an award-winning staffing firm that works with many leading technology-based companies around the world. The benefits offered to our employees include Health Insurance (Medical, Dental, and Vision), Cafeteria Plan (HSA, FSA, and dependent care), 401(k) (enrollment subject to eligibility), and Sick Pay (varies based on city and state laws). 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 operations, FDA, CPA, CTMA,EMA, ICH, GCP, Excel, PowerPoint, Outlook, Clinical Operations
Duration: 18 + Months Contract (Possibility for Extension)
Contract Type: W2 Only
Please apply directly with your update resume or call Vaibhav at 408-512-2355
- At least 5+ years of experience and a BS or BA in a relevant scientific discipline.
- At least 5+ years of experience and an RN (2 or 3 year certificate).
- Excellent teamwork, communication, decision-making and organizational skills are required.
- Thorough knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies.
- Working knowledge and experience with Word, PowerPoint and Excel.
- Must have a general, functional expertise to support SOP development and implementation. Maintains a good understanding of industry standards and regulations for CO and ISR studies and keep abreast of any new changes and developments impacting Late Phase clinical operations.
- For Client studies, contributes to development of RFPs and participates in selection of CROs/vendors.
- For Client studies, may be asked to train CROs, vendors, investigators and study coordinators on study requirements.