Clinical Trial Specialist (gn)

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MorphoSys’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, collaborating closely across disciplines. We all are driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of the MorphoSys team is given the opportunity to develop and flourish within this exciting and inspiring environment. Join us in Planegg near Munich!

Your Responsibilities:

1. Work in collaboration with the CTL and contribute to the conduct of the trial by:
  • Coordinating and participating in Clinical Trial Team (CTT) meetings, preparing meeting minutes and tracking and following up on outstanding actions
  • Ensuring all operational trial deliverables as assigned 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/systems (e.g. central laboratories, interactive response technologies (IRT), clinical supplies) with the vendors as per protocol requirements
  • Setting up and maintaining clinical trial insurance in participating countries
  • Managing and overseeing the activities of the vendor(s) as assigned
  • Managing interactions between the CTT and vendors
  • Planning investigator meetings or equivalent investigator training and monitor trainings
  • Collecting and tracking trial status such as enrollment and timelines and for updating the relevant internal/external boards
  • Managing Trial Master File (TMF) and ensuring implementation of TMF management plan and QC plan
  • 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
2. Develop and oversee the execution of IRB/IEC submission plan for initial protocol and its
amendment(s) for the trial:
  • Develop the IRB/IEC submission plan in collaboration with the CTL, Clinical Trial Manager (CTM), Regulatory Affairs Manager (RAM) and the CRO for implementation in the participating countries and clinical sites to obtain approvals to conduct the trial
  • Coordinate the collection of the required trial documents from the CTT for provision to the CRO to facilitate the IRB/IEC submissions
  • Monitor the progress of the status of the IRB/IEC submissions and approvals and intervene as required to resolve the issue with the CRO
  • Ensure the feedback from the IRB/IEC is provided to the CTT for responding and the response is provided on time to the CRO for submitting to the IRB/IEC

3. Ensures inspection/audit readiness including TMF documentation and participates in internal audits and inspections as required

4. Contributes to process improvement or acts as Subject Matter Experts for training or SOPs

Job Qualifications:

  • 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

Thank you for your interest! We are looking forward to receiving your pertinent application documents. For your application please use exclusively our career portal. We offer not only excellent career prospects, but also support you from the very beginning – even helping you move if necessary.

MorphoSys AG, Semmelweisstraße 7, 82152 Planegg