Clinical Trial Specialist (m/f/d)

Our client’s mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines. Our client is driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of the team is given the opportunity to develop and flourish within this exciting and inspiring environment.

 

We are searching for a

Clinical Trial Specialist (m/f/d)

  • Bereich:

    Medical

  • Berufssparte:

    Forschung/Entwicklung

  • Arbeitsregion:

    Near Munich

  • Art der Anstellung:

    Interim

  • Kennziffer:

    26038

  • Aktualisierung:

    29.06.2020

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Your tasks

Work in collaboration with the Clinical Trial Leader (CTL) and contribute to the conduct of the clinical trial by:

  • Coordinating and participating in Clinical Trial Team (CTT) meetings, prepare meeting minutes and track / follow-up on outstanding actions
  • Ensuring all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards
  • Preparing trial outsourcing specifications and participate in the vendor selection process
  • Setting up and maintaining trial-related processes and systems (e.g., central laboratories, interactive response technologies (IRT), clinical supplies) with vendors as per protocol requirements
  • Managing Trial Master File (TMF) and ensuring implementation of TMF management plan and QC plan
  • Managing interactions with the CTT and vendors
  • Planning investigator meetings or equivalent investigator training and monitor trainings
  • Collecting and tracking trial status such as enrollment and timelines for updating the relevant internal / external boards
  • Ensuring accuracy of trial information in all trial databases, TMF, and tracking systems
  • Coordinating trial close out activities and ensuring completion of final drug accountability
  • Ensure inspection / audit readiness including TMF documentation and participate in internal audits and inspections as required
  • Contribute to process improvement or acts as Subject Matter Expert for training or SOPs

Your qualification

  • Ideally at least three years of experience in Clinical Trials
  • Good knowledge of Good Clinical Practice
  • Familiar with clinical trial and drug development processes
  • Ability to work in a matrix organization and demonstrated collaboration skills
  • Ability to work under pressure
  • Effectively prioritize workload
  • Fluent English, both written and oral 

We offer

  • Creative working in X-functional teams
  • Open and appreciative corporate culture
  • Multicultural environment
  • Working in an attractive, high-quality equipped building with restaurant
  • Free sports and language courses

Ihr Ansprechpartner

Jan Büscher
Geschäftsführer

Anschrift

Optares ICM GmbH & Co. KG
Jan Büscher
Heiligengeist Höfe 8
26121 Oldenburg