Job Category: Clinical Affairs
Job Number: 11676528
Akraya is looking for a Clinical Trials Management Associate for one of our clients.If the job description below is a fit, please apply directly or call Utkarsh Audut at 408-239-4597. 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 Trials, Clinical Study, Knowledge of FDA, EMEA, ICH, and GCPs & SOP development
Duration: 12 Months
Contract Type: W2 only
- Oncology experience is a must
- CTMA -Late Phase plays vital role in successful implementation and support of important Collaborative (CO) and Investigator-Sponsored Research (ISR) projects. With supervision:
- Serves as the key operational contact with external investigators and internal stakeholders.
- Able to evaluate a scientific proposal or protocol to identify logistical, regulatory and safety elements and implications.
- Manages assigned studies by establishing strong partnerships with external investigators and collaborators to ensure CO and ISR Agreements and financial or product support are processed in a timely manner and to high quality.
- Maintains efficient collaboration with company’ s Clinical Contracts and Finance (CCF) team and external investigator/study representative to ensure contracts are executed in timely manner.
- Supports study drug planning and shipping activities with Materials & Logistics.
- Communicates and collaborates with other functional groups including but not limited to Medical Affairs, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities.
- Forecasts, tracks and reports CO and ISR milestones, as well as verifies completeness of the study milestones prior to invoice payment.
- Implements working processes to promote high quality, efficient, and compliant systems for Late Phase research management.
- Supports and implements Clinical Operations Quality Initiatives.
- Maintains internal Clinical Operations and Medical Affairs databases and clinical study data and document repositories.
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials, and ability to understand clinical study protocols a plus
- Must be proficient with MS Word, PowerPoint, Outlook, and Excel.
- Must be familiar with routine medical/scientific terminology
- Must be able to participate in departmental or interdepartmental strategic initiative under general supervision.
- Must be able to contribute to SOP development.
- Typically requires a BS or BA in a relevant scientific discipline and minimum 2 years relevant clinical experience in the pharmaceutical or health care industry or equivalent.
Please apply directly with your updated resume or call Utkarsh Audut at 408-239-4597.
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.