Information Technology

Employment TYPE

Contract

LOCATION

Irvine , California

DATE POSTED

April 8, 2019

INDUSTRY

Information Technology

POSITION(S)

1

SALARY

Negotiable

Job# J449

Sr. Associate Clinical Trial Management

About The Opportunity

Job Description

  • 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

Required Skills

  • 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

Duration

12 Months

Please Contact me to discuss the hiring process!

Drake Jones

Sr. Executive Recruiter
Contact: (310) 929-8421 Ext: 105
Email: drake.jones@staffactory.com

Hi! My name is Drake. I love to help our placed consultants when they face any problem. Not only this, I work with consultants who have applied for any job with us and introduced them to our company culture. Additionally, I make sure that I do telephonic follow-ups with all the consultants working with us and let them know about the current status of their applications. I also make sure that our consultants are happy with the results.