Associate, Clinical Trial Manager (3yrs exp)A9289

TechData Service Company LLC. - Irvine, CA

Contract

Position Title: Associate, Clinical Trial Manager (Contract role)

Contract Term: 1 year with potential contract extension

Location: Irvine, CA

Description:

Position Summary:

  • supports CTM/OSL in ensuring the assigned clinical study(ies) are run on time and to

budget and are completed in compliance with all relevant laws, regulations, and
regulatory guidelines as well as all Allergan policies and procedures

Tasks:
Assist CTM/OSL with:

  • regional site feasibility, when necessary
  • tracking of site training, certification, delivery of ancillary supplies, etc., necessary for

site activation

  • development of study-specific documents, when necessary
  • regional vendor management: manage vendor issues, coordinate contract

amendments, create monthly vendor accruals, process and track monthly invoices,
provide quarterly budget forecast assumptions

  • periodic review of protocol deviations
  • database lock activities (interim or final lock)
  • regional study drug management: track shipping or storage site temperature

excursions

  • regional trial master file management (TMF): ensure all documents are

appropriately filed in the TMF

  • regional enrollment management: site activation and enrollment tracking for

monthly reporting

Experience:

  • 3+ years relevant experience at pharmaceutical CRO or sponsor
  • Experience supporting clinical trials
  • Handle and prioritize multiple tasks simultaneously
  • Work effectively in a team/matrix environment
  • Understand technical, scientific and medical information
  • Handle conflict management and resolution
  • Familiarity with clinical study budgets and accruals

Knowledge:
Candidate must have a good understanding of the following:

  • Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical

research ethics, HIPAA and patient privacy laws (plus applicable local regulations,
when country-based)

  • Knowledge of concepts of clinical research and drug development
  • Prefer but not a must have – Ophthalmology area experience

Qualifications:

  • Bachelor’s degree or higher
  • Science degree preferably in science or health-related field
  • Previous experience of working on a clinical study

Other:

  • Position is Irvine, CA based but may have option to work from home 2 days per week

Job Type: Contract

Experience:

  • Clinical trials: 3 years (Preferred)

Education:

  • Bachelor's (Preferred)