clinical operations in bridgewater

posted
job type
contract
salary
US$ 60.18 per hour
apply now

job details

posted
location
bridgewater, new jersey
job category
Biotechnology & Pharmaceutical
job type
contract
salary
US$ 60.18 per hour
reference number
25753
apply now

job description

Job Title: Clinical Trial Operations Manager III

Job Summary

  • This role will also support the Senior Lead CTOM and/or Lead CTOM for the preparation of study related materials, relationship management between clinical sites and vendors, and identification of project risks and contingency planning ensuring that all activities are managed to the highest quality to strive for safety and effectiveness of company products. Trial Mgmt, pre-approval inspection readiness experience required

Job Responsibilities

  • Provide oversight on study activities to ensure progress according to study timelines
  • Support the Senior Lead CTOM and/or Lead CTOM in taking study logistic decisions and implementing operational plan(s) upon endorsement by the study team
  • Ensure proper documentation availability
  • Ensure proper collection and validation of data and documentation on a timely manner
  • Organize and lead study meetings
  • Collect, synthesize and report study information
  • Collaborate with the Clinical Supplies Platform to validate Investigational Medicine Product (IMP) needs, specifications, packaging, shipment (including resupply) and reconciliation process
  • Participate in selection and management of vendors, development/follow-up of the associated budget
  • Preparation and oversight of study audits/inspections both internal and external
  • Provide oversight and preparation for FDA pre-approval inspections (PAI)
  • Participate in the training of new CTOMs on therapeutic area and general responsibilities within their function

Education & Qualifications

  • Bachelor's Degree plus
  • At least 2 years of experience in the pharmaceutical industry or clinical-related discipline (including at least 1 year of clinical research experience).
  • Advanced Degree in scientific discipline preferred, equivalent RN

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.