Clinical Trial Manager, Senior - CA in Irvine, CA at Apex Life Sciences

Date Posted: 2/2/2018

Job Snapshot

  • Employee Type:
  • Location:
    Irvine, CA
  • Job Type:
  • Experience:
    At least 5 year(s)
  • Date Posted:
  • Job ID:

Job Description


  • Accountable for leading the operational study team, which is responsible for the execution and delivery of quality studies, including in-process quality control activities (e.g. quality checks and balances to ensure inspection readiness, enrollment, metrics, milestones, timelines and budget). 
  • This position requires advanced knowledge of the functional disciplines necessary to guide the operational objectives to ensure execution and delivery of quality studies within defined timelines and budget. 


Primary responsibilities of this position include: 

  • As the operational study lead, serves as the primary representative of Clinical Operations to Clinical Affairs and other functions supporting the execution and delivery of an assigned study(s) (e.g. Clinical Planning, Regulatory Affairs, Global Drug Safety, Pharmaceutical R&D, R&D Quality Assurance). 
  • Supports the Clinical Program Manager by providing study status updates, and informs and as needed escalates issues; Provides operational support as needed at various meeting interactions with, as example, advisors or Partners. 
  • Accountable for the execution and adherence to integrated study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders inclusive of all operational accountabilities, including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as FRI’s SOPs and policies. 
  • Accountable for accurate and timely entry of study information (e.g. design, results) into ClinicalTrials.Gov in collaboration with RAs and Clinical Affairs. 
  • Accountable for monitoring study operational plan, and managing operational study budget,
  • Accountable for the management and maintenance of the study TMF. 
  • Accountable for leading, and managing the process for the selection, contracting and oversight of CROs and clinical trial related vendors in collaboration with the study team, CRO Management, Clinical Affairs and key stakeholders. 



  • B.S. degree; Advanced degree (e.g. Master, PharmD, PhD) preferred 


  • Minimum of 5 years of pharmaceuticals/biotech experience 
  • Minimum of 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials 
  • Extensive experience in the operational and scientific/medical aspects of clinical development. 
  • Critical thinking skills, and ability to identify potential issues and solutions, across clinical development programs. 
  • Strong project management, leadership and mediation skills within a matrix environment. 
  • Continuous improvement experience preferred. 
  • Ability to work across broad range of interfaces, and take broad perspective to harmonize processes and procedures. 
  • Demonstrated ability to develop and manage end to end study operational plan 
  • Demonstrated ability to operationally execute and deliver a quality clinical trial 
  • Proven leadership abilities and demonstrated experience directly working in multidisciplinary study teams 
  • Demonstrated ability to execute within a matrix management model, ideally in pharmaceuticals/biotech 
  • Timeline, budget and resource management experience required 
  • Demonstrated experience in change management initiatives preferred 
  • Program and project management experience preferred 
  • International experience a plus

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or 844-463-6178.