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Senior Clinical Trial Specialist in San Rafael, CA at Apex Life Sciences

Date Posted: 11/19/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/19/2018
  • Job ID:
    915850

Job Description


Duties:

  • The ideal candidate would be a clinical research professional passionate about operations with up 4 years experience in Clinical Operations, focused on working to ensure delivery of quality data, and committed to helping our patients.
  • A proactive problem solver who shows flexibility and an ability to communicate efficiently.
  • The Sr. Clinical Trial Specialist (Sr. CTS) performs essential responsibilities for successful trial execution.
  • He/She takes on the key role of Study Specialist in the operational team, contributing to, or leading tasks related to study management and oversight activities.
  • This may include contributing to and/or supporting study matters that impact study timelines, quality and budget.
  • Following demonstrated success in the Study Specialist role, the Sr. Clinical Trail Specialist may have the opportunity to take on regional operations responsibilities including managing issues and opportunities that impact regional study timeline, quality and budget; overseeing the CLO team, vendors and CRO for the study in the region; and escalating regional decisions, issues and risks.
  • Manage and track vendor adherence to SOW and oversight plan for assigned vendors Lead protocol deviation meetings, if assigned
  • Contribute to or be responsible for the development of vendor specific timelines ensuring alignment with study level timelines
  • Manage Change Order and Change Negotiation Form (of vendors) processes, in collaboration with Business Operations Review and approve invoices for assigned vendors
  • Ensure investigator payment: site setup, pass-through processing, visit payment processing and funding processing
  • Drive day-to-day management of assigned vendors
  • Communicate study performance expectations to vendors, manage and track vendor performance metrics at a study level
  • A diverse set of operational responsibilities related to the startup, the conduct and the close-out of clinical trials

Skills:

  • The Senior Clinical Trial Specialist is expected to have foundational competence in critical areas such as Communication and Problem solving.
  • You are also expected to be proactive and able to make decisions.
  • Responds promptly with clear, organized written and oral communication
  • Seeks out, and understands the value of, opportunities to interact with peers and stakeholders; builds a network of internal and external peers
  • Takes ownership and accountability for completing assigned tasks and perseveres through obstacles
  • Embraces new challenges or changed priorities and adjusts plans and priorities accordingly
  • The Senior Clinical Trial Specialist has foundational technical competence in Study Management and Execution, Compliance and Quality, Drug Development and Study Design, and Product and Therapeutic Area Knowledge.

Education:

  • BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered. 4+ years pharmaceutical industry experience

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 844-463-6178.




915850