Clinical Operational Manager (gn)

Organizes the Clinical Trial Team (CTT) meetings including agenda preparation, actions tracking and follow-up; ensures assigned operational trial deliverables and their associated project plans are met according to timelines, budget;...

At MorphoSys, our ambition is to redefine how cancer is treated. As a global, commercial-stage biopharmaceutical company, we are driven by the urgency to discover, develop, and deliver groundbreaking medicines, aspiring to give more life for people with cancer.

Our success is created by our people and we bring together exceptional talent from around the world. We are an equal opportunity employer and take pride in offering our colleagues an open, flexible, and diverse work environment. We are looking for people who share our values and are motivated to improve the lives of people impacted by cancer.

Our headquarters are in Planegg, Germany, and our U.S. operations are anchored in Boston, Massachusetts. To learn more, visit us at www.MorphoSys.com, and follow us on Twitter and LinkedIn.

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

Your Responsibilities:

1. Being a core member of CTT (including deputizing the CTL during his/her absence in leading the CTT) and contributes to the conduct of the trial by:

• Organizes the Clinical Trial Team (CTT) meetings including agenda preparation, actions tracking and follow-up
• Ensures assigned operational trial deliverables and their associated project plans are met according to timelines, budget, operational procedures and quality standards
• Oversees 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
• Manages and coordinates Investigational Medicinal Products (IMP) and non-drug supplies across regions and countries in collaboration with Clinical Trial Supply Manager
• Prepares trial outsourcing specifications with input from the CTT, and coordinate the vendor selection process including business process walkthrough together with the Purchasing Manager
• Collects and tracks 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)

2. Prepares, implements and manages assigned vendors including their sub-contractors:

• In collaboration with other CTT functions, set-up and maintains trial-related processes / systems and their key performance indicators (e.g. regional Contract Research Organizations (CROs), 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
• Manages and oversees vendor activities and interactions during the conduct of the trial to ensure adherence to the agreed contract, timelines and budget
• Accesses and addresses vendor performance ongoing during the trial conduct and escalate (if required) to the CTT for further actions

3. Takes the role of a CTL as assigned in clinical trial and leads the cross-functional CTT to operationalize the protocol

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

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

6. Coaches new COMs and Clinical Operational Specialists (COSs) during their onboarding as assigned

Job Qualifications:

• Master’s / Bachelor’s degree or equivalent qualification in life science / healthcare
• Ideally at least five years of clinical research experience
• Previous involvement with clinical trial development, implementation or reporting activities preferred
• Through knowledge of Good Clinical Practice and familiar with the end-to-end clinical trial process including the interfaces
• Excellent interpersonal, communication, organization and coordination skills
• Strong leadership with ability to lead cross functional teams in a matrix environment and demonstrates collaboration skills
• Possesses analytical skills and displays innovative ideas and solutions
• 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
• Simplified application for people from Ukraine (fast track via LinkedIn Profile); additional relocation package

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