Clinical Operational Manager (gn)

Being a core member of Clinical Trial Team (CTT) including deputizing the CTL during his/her absence in leading the CTT; organize CTT meetings including agenda preparation, actions tracking and follow-up; collect and track trial status;...

MorphoSys’ 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. 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!

We would like to fill the following vacancy as soon as possible:

Your Responsibilities:

• Being a core member of Clinical Trial Team (CTT) including deputizing the CTL during his/her absence in leading the CTT
• Organize CTT meetings including agenda preparation, actions tracking and follow-up
• Collect and track trial status such as enrollment and timelines to monitor the trial progress and to update the relevant internal / external boards (e.g. Global Program Team)
• Prepare trial outsourcing specifications with input from the CTT, and coordinate the vendor selection process including business process walkthrough together with the Category Manager
• In collaboration with other CTT functions, set-up and maintain trial-related processes/systems and their key performance indicators (e.g. central laboratories, interactive response technologies (IRT), Clinical Trial Management Systems (CTMS), data analytics tools, clinical supplies) with the vendors as per protocol requirements and internal standards
• Oversee the interfaces between the trial vendors and the established processes / systems to ensure accurate data or information flow including data integration, data transfer and reconciliation of information at the agreed time intervals
• Access and address vendor performance during the trial conduct and escalate (if required) to the Clinical Trial Team for further actions
• Develop the ethics submission plan in collaboration with the Clinical Trial Leader, Clinical Trial Manager, Regulatory Affairs Manager and the CRO for implementation in the participating countries and clinical sites to obtain approvals to conduct the trial
• Monitor the progress of the status of the ethics submissions and approvals, and intervene as required to resolve the issue with the CRO
• Take the role of a CTL as assigned in clinical trial and lead the cross-functional CTT to operationalize the protocol
• Ensure inspection / audit readiness including TMF documentation and participates in internal audits and inspections as required

Job Qualifications:

• Bachelor’s or Master’s Degree / PhD or equivalent qualification in life science / healthcare
• Ideally a minimum of five years clinical research experience, previous involvement with clinical trial development, implementation or reporting activities preferred
• Knowledge of Good Clinical Practice and experience with the end to end clinical trial process including the interfaces
• Strong leadership with ability to lead a cross functional team in a matrix environment and to demonstrate collaboration skills
• Excellent interpersonal, communication, organization and coordination skills and ability to influence without authority
• Ability to resolve issues independently and understand when to escalate
• Fluent English (oral and written)

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 www.morphosys.com/careers/job-opportunities. 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