Job Category: Clinical Affairs
Job Number: 11852136
Akraya is looking for a Clinical Trials Manager for one of our clients. If the job description below is a fit, please apply directly or call Ashu Pandey at 408-907-2228. If this position is not quite what you’ re looking for, visit akraya.Com and submit a copy of your resume. Our recruiters will get to work finding you a job that is a better match at one of our many clients.
Primary Skills: Clinical trial, Clinical operations, Clinical, Registered Nurse, FDA, CPA, CTMA, EMA, ICH, GCP, Excel, PowerPoint, Outlook, Clinical Operations, Clinical etc.
Duration: 18 + Months Contract (Possibility for Extension)
Contract Type: W2 Only
- Clinical Trials manger will serve as the key operational contact with external investigators and internal stakeholders, for successful implementation of Client (Client), Collaborative (CO), Investigator Sponsored Research (ISR) Studies, expanded access programs, and compassionate use programs and Has ability to critically evaluate scientific proposal or protocol, and budget for clinical operation feasibility and fair market value assessment
- Establishes strong partnerships with external investigators and collaborators to ensure ongoing activities (e.G. Sponsor updates, drug shipments, publications, milestone payments, etc) for CO and ISR studies are executed in a timely manner and with high quality
- Establishes strong cross-functional relationships and exhibits strong leadership skills with counterparts in other functional teams (e.G., CSM, CCF, DSPH, and Medical Affairs) to ensure efficient execution of the study management processes.
- Implements and maintains working processes to promote high quality, efficient, and compliant systems and tools for CO and ISR study management
- 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.
- Organizes and leads clinical operational meetings
- Maintains internal Clinical Operations databases and document repositories
- For Client studies, drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, and clinical study reports
- Maintains study timelines
- Coordinates review of data listings and preparation of interim/final clinical study reports
- Assists in determining the activities to support a project’ s priorities within functional area
- 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.
- Contributes to development of study budget.
- May serve as a resource for others within the company for clinical trials management expertise.
- Able to examine functional issues from an organizational perspective.
- Participates in the recruiting and hiring process for CPA/CTMA/Sr. CTMA and support their professional development.
Experience and Skills:
- 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.
Please apply directly with your update resume or call Ashu Pandey at 408-907-2228
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.