(Senior) Clinical Trial Manager (897265 – SLV)

Canton of Basel-Stadt (CH)
19 Feb 2021
21 Mar 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)

As a (Senior) Clinical Trial Manager will be responsible for the overall conduct of clinical trials from start to closure, as well as from protocol development to final data review and reporting, to ensure completion through all phases on time, within budget and of high quality in compliance with all applicable regulations, ICH-GCP guidelines and standard operating procedures (SOPs).

This role is a 12-months contract with high chances to be extended and based in Basel, Switzerland. 

Main Responsibilities:

  • Responsible for the operational conduct and management of assigned clinical trial(s) in close collaboration with other functions, including the development of the clinical study protocols and related-documents
  • Contribute to the development of regulatory documents (e.g. IB / IMPD / DSUR) and responses to Health Authorities/Ethics
  • Responsible for delivering clinical activities on the assigned trials towards the CROs and other vendors and External Service Providers (ESPs) selected for the trial, to ensure compliance with study protocol and in accordance with scope of work/budget
  • Selection and training of ESPs
  • Responsible for the development, management and tracking of the clinical trial budget, including timely and accurate communication for internal reporting, working closely with the HCO
  • Prepare and formulate critical decisions, mapping out options and obtain internal approval
  • Proactively identify deficiencies and new risks in trial conduct, suggest corrective actions in timely fashion and escalate internally, as required
  • Provide regular updating on clinical trial level activities for internal reporting
  • Responsible for the development and management of study timelines, risk and quality plans
  • Organize as required scientific/medical review and evaluation of clinical trial data, including the development of clinical trial reports
  • Responsible for the Trial Master File completeness for audit/inspection readiness and investigator site files
  • Contribute in forecasting drug supply needs
  • Ensure and support feasibility activities as needed
  • Responsible for all study-related meetings and training sessions
  • Supporting in developing internal SOPs and in the conduct of audits, as needed
  • Assume responsibility for other projects or trial-related duties as assigned.

Qualifications and Experience:

  • MSc in Life Sciences / Healthcare or equivalent
  • 8+ years of experience in the Clinical Development and Trial Management (either CRO or industry/biotech experience) including a minimum of 5 years’ experience in managing all operational aspects of clinical trials from initiation to closure
  • Previous exposure to working on Phase II and III trials, is a major asset
  • Substantial exposure across the whole Clinical Operations & Development process
  • Fluent in both written and spoken English. Any additional language is an asset
  • Solid track record on the management of ESPs and Third-Party Vendors
  • Very good knowledge of ICH-GCP and clinical trial process
  • Relevant working/residency permit or Swiss/EU-Citizenship required.

Similar jobs

Similar jobs