Our client is a privately held Swiss Specialty Pharma company focused on the development of a new kind of drugs addressing different types of diseases. Thanks to their recent success, they are currently expanding their clinical development activities and they are looking for an immediately available Clinical Trial Manager to close out an Oncology study in phase I.

 

" /> Our client is a privately held Swiss Specialty Pharma company focused on the development of a new kind of drugs addressing different types of diseases. Thanks to their recent success, they are currently expanding their clinical development activities and they are looking for an immediately available Clinical Trial Manager to close out an Oncology study in phase I.

 

" />

Clinical Trial Manager-Oncology (Immediately available)

Inactive

Reference Number: 895999-W
Type of placement: Contract
Location: Switzerland, North West

Introduction:

To contribute on the closure of a complex international phase I study in Oncology.

Main Responsibilities:

  • Verify subject records for completeness, subject closure, outstanding AE’s, referrals, etc.
  • Data entry or verification, query reviews, data analysis, database lock
  • Review all TMF’s and ISF’s (as applicable) documentation for completeness
  • Verify regulatory documents up to date and on file
  • Ensure completeness of final reports and submission dossier
  • Update financial records
  • Ensure unused supplies are returned or destroyed according to trial requirements

 

Qualifications and Experience:

  • Degree in Life Sciences
  • Experience in closing out complex international studies, ideally in phase I-II, within the pharmaceutical industry
  • Oncology experience is a must
  • Strong working knowledge of GCP, FDA regulations and current industry practices
  • Ability to work independently and deliver under limited timelines
  • Fluent in both written and spoken English
  • Relevant working/residency permit or Swiss/EU-Citizenship required