Clinical Trials Management Associate : 18-02559

Foster City, CA 94404

Posted: 11/15/2018 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 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: 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 @ 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.

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