Clinical Trial Leader (gn)

82152 Planegg, 82152 Krailling, 82152 Planegg, 80331 München
12.10.2020

Daten dieser Anzeige

Job-ID: 017330240
Clinical Trial Leader (gn)

MorphoSys AG

Germany

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Leads the global cross-functional Clinical trial Team Provides direct operational input into protocol development to ensure efficient and effective delivery of trial objectives Ensures trial operational plans are developed by the vendors with inputs from CTT Develops and executes operational risk management plan highlighting potential risks and actions Creates and drives trial level timelines and deliverables Ensures all trial related documents and systems (e. g. clinical database, IRT and etc.) required for Ethics / Regulatory submissions and trial initiation are developed by the CTT and vendors within the specified timelines Manages and oversees vendor activities and interactions during the conduct of the trial to ensure adherence to the signed contract and agreed timelines and budget Reports and assesses vendor performance ongoing during the trial Collaborates with Clinical Trial Supply Management and vendors to ensure all aspects of the IMP and non-drug supplies (if applicable) are managed throughout the trial Manages and oversees resolution of trial operational issues Collects, tracks, and communicates trial status to the relevant internal / external boards Accountable for accuracy of trial information in all trial databases, trial master file, and tracking systems Manages trial budget, obtains relevant internal board approvals, revises budget when applicable, and reconciles at trial close out Participates in inspection / audit and ensures timely response to inspection / audit observations or other quality issues in cooperation with Quality Assurance Collaborates with CTT to define the scope of responsibilities of operational and medical / clinical data review within the data management plan or equivalent to ensure ongoing quality data review

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: Clinical Trial Leader (gn) Your Responsibilities: Leads the global cross-functional Clinical trial Team Provides direct operational input into protocol development to ensure efficient and effective delivery of trial objectives Ensures trial operational plans are developed by the vendors with inputs from CTT Develops and executes operational risk management plan highlighting potential risks and actions Creates and drives trial level timelines and deliverables Ensures all trial related documents and systems (e. g. clinical database, IRT and etc.) required for Ethics / Regulatory submissions and trial initiation are developed by the CTT and vendors within the specified timelines Manages and oversees vendor activities and interactions during the conduct of the trial to ensure adherence to the signed contract and agreed timelines and budget Reports and assesses vendor performance ongoing during the trial Collaborates with Clinical Trial Supply Management and vendors to ensure all aspects of the IMP and non-drug supplies (if applicable) are managed throughout the trial Manages and oversees resolution of trial operational issues Collects, tracks, and communicates trial status to the relevant internal / external boards Accountable for accuracy of trial information in all trial databases, trial master file, and tracking systems Manages trial budget, obtains relevant internal board approvals, revises budget when applicable, and reconciles at trial close out Participates in inspection / audit and ensures timely response to inspection / audit observations or other quality issues in cooperation with Quality Assurance Collaborates with CTT to define the scope of responsibilities of operational and medical / clinical data review within the data management plan or equivalent to ensure ongoing quality data review Requirements: Ideally a minumum of five years operational experience in planning / executing / reporting clinical trials on international level Thorough knowledge of Good Clinical Practice, regulatory processes, and clinical development process Experience with health authority inspections (FDA and / or EMEA) preferred Demonstrated ability to effectively manage trial budget Strong leadership and project management skills in a cross functional and multicultural team Excellent in negotiation and conflict resolution 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

Pharma, Chemie, Med.-/ Biotechnologie

Forschung & Entwicklung

Medizinische Tätigkeiten/ Gesundheits-/ Sozialwesen

Chemie/ Pharma/ Biotechnologie

Bereichs-/ Abteilungs-/ Gruppenleitung

Vollzeit

82152 Planegg

82152 Krailling

80331 München