Clinical Trials Management Associate - I : 18-05497

Foster City, CA 94404

Posted: 12/13/2018 Job Category: Clinical Affairs Job Number: 11676530
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 Sherwin Gardner at 408-338-6119. 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
Location: Foster City, CA 94404
Contract Type: W2 only

Job Description:
  • 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.
  • Provides monthly study updates to the appropriate internal stakeholders. Ensures all budget or drug supply modifications are appropriately approved, documented and tracked.
  • 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.
Skills/Experience requirements:  
  • 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 update resume or call Sherwin Gardner at 408-338-6119.
About Akraya:
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.

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