Global Clinical Manager

Job type:
on-site
Start:
07/2018
Duration:
07/2022
Place:
Basel-City
Date:
06/29/2018
Country:
flag_no Switzerland
project ID:
1590038

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Title: Global Clinical Manager

Location: Basel

Start: ASAP

Contract: 24 months (1 year to begin with)

Job Purpose:

I am recruiting for an urgent position for my pharma client based in Basel. The Global Clinical Manager will have a great mix of scientific (research) and operational (trials) experience. Within the scientific stream, your responsibilities will involve writing protocols, translating study plans, briefing partners about the procedures. Within the operational aspects you will contribute to the oversight of all global clinical trials to deliver study outcomes within schedule, budget, quality/compliance and performance standards.

Please refer to the requirements below:

Responsibilities:
  • You will contribute to all operational trial deliverables, according to timelines, budget, operational procedures
  • Development of specific sections of the protocol and study tools, guidelines and training materials;
  • Supporting forecast and management of drug supply for clinical trials
  • Oversee bid process and selection of CROs; managing interface with CROs in cooperation with outsourcing management and line functions; ensuring vendors meet quality standards; contributing to the development/amendment of vendor contracts;
  • Contributing to the development of CRFs, edit checks, CRF completion guidelines, data review reports and trial statistical analysis plan in collaboration with the trial data manager, trial statistician, statistical programmer and clinical development representative;
  • Contributing to the creation and execution of an operational risk management plan, highlighting potential risks and actions;
  • Supports the Director with the development, management and tracking of the trial level life cycle budget incl forecast, and annual cost targets.
  • Define the data review plan; participate in data review as specified in the Data Review Plan.
  • Contribute to talent development through active participation in onboarding and training activities.
  • Responsible for education, implementation and compliance to standards (SOPs) and best practices for trial management within assigned clinical trials and within clinical programs and franchise, including sharing lessons learned.


Requirements:

Education: PhD in Life Sciences

Experience:
  • 5+ years experience within a large Pharma or Biotech environment
  • Clinical Research experience with significant global experience across all clinical phases of drug development (I - IV).
  • Intense collaboration with and management of country affiliates and third party providers.
  • Significant experience in clinical operations, preparation of forecasts and budgets, global and local study conduct and science which includes CRO/3rd party vendor selection, management and performance management (development and implementation of performance metrics, KPIs).
  • Starting-up a clinical operations function.
  • Proven experience in defining strategy and ensuring implementation across functions.
  • Setting up systems, processes and SOPs to simplify and streamline the productivity.
  • Expert matter in Quality Assurance (GCP/GLP).


Get in touch: luchele.mendes(at the rate of) mbaswitzerland.com call +41 (0)

Michael Bailey International is acting as an Employment Business in relation to this vacancy.