Clinical Trials Management Associate : 18-02559

Foster City, CA 94404

Posted: 01/15/2019 Job Category: Clinical Affairs Job Number: 10947017
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 Chetna  at 408-329-6544.  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: Biomarker, Lab experience
Duration: 6 Months
Contract Type: W2 only

  • Must meet all requirements for Clinical Trials Management Associate (CTMA) position and must have demonstrated proficiency in all relevant areas
  • Serves as the key biomarker operational contact with internal and external stakeholders, for successful implementation of biomarker strategy in Gilead (GS) and Collaborative (CO) programs
  • Participate in multiple Phase 1-3 teams to manage biomarker implementation in clinical trials
  • Plans and coordinates all operational activities required with the collection, delivery and analysis of biomarker samples within a clinical trial
  • Provides sample management expertise to the Study Management Teams (SMTs)
  • Accountable for ensuring biomarker samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed consent.
  • Collaborate with biomarker biology to translate sample processing and handling instructions from research setting to the clinical setting
  • Primary interface for operational activities between the SMT and biomarker laboratory vendors; Provides the day-to-day operational management of biomarker vendors to ensure delivery against contracted scope of work
  • Able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions
  • Participate in or manage project meetings and conference calls with CROs, vendors, and multi-functional teams
  • Able to anticipate obstacles and proactively develop solutions to achieve project goals
  • Develop a general understanding of functional issues and routine project goals from an organizational perspective
  • Participate oral presentations as applicable, interact and cooperate with individuals in other functional areas to address routine study issues
  • Develop tools and processes that increase measured efficiencies of the project
  • Assist in trainings for Clinical Trials Management Associates (CTMAs) and Clinical Project Assistants (CPAs),
  • Assist in selecting Contract Research Organizations (CROs) or vendors as needed
  • Assist with the setting and updating of study timelines, participate in departmental, or interdepartmental, strategic initiatives under general supervision
  • Conduct vendor visits and provide site training, as needed under general oversight
  • Ensure that the site complies with the protocol and regulatory requirements for GS studies
  • Review of protocols, informed consents, and relevant study documents
  • Travel may be required
  • Excellent verbal, written, interpersonal and presentation skills are required
  • 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
Experience and Skills:
  • At least 3+ years of experience and a BS or BA in a relevant scientific discipline (e.G. Clinical Operations and/or Sample Management) or at least 3+ years of experience and an RN (2 or 3-year certificate)
  • Pharmaceutical industry experience or experience working as a clinical trial coordinator within a clinical trial setting is a plus
  • Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples is a plus
      Please apply directly with your update resume or call Chetna at  408-329-6544
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.

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.