Trial Monitoring Leader - Munich, Deutschland - MorphoSys AG

Beschreibung

As a global, commercial-stage biopharmaceutical company, we are driven by the urgency to discover, develop, and deliver groundbreaking medicines, aspiring to redefine how cancer is treated.

Our success is created by our people, and we bring together exceptional talent from around the world, offering our colleagues a collaborative, flexible, and diverse work environment.

We are looking for individuals who share our values and are motivated to improve the lives of people impacted by cancer.

The Trial Monitoring Leader supervises Trial Monitoring Managers (TMMs), overseeing their operational activities, and managing their performance and career development.

The Trial Monitoring Leader works in collaboration with Trial Monitoring Head to facilitate the allocation of TMMs across clinical studies and with Program Operational Leaders (POLs) to ensure efficient execution and quality oversight of clinical studies.

• Responsible for the hiring, onboarding, training, and mentoring of TMMs
• Manages TMMs including providing guidance, mentoring, and assistance in setting workload priorities
• Performs ongoing performance review including objective setting and provides frequent feedback
• Supports career development and manages performance issues proactively through customized quality development plans addressing strengths and skill gaps
• Identifies training needs of the group to foster high levels of performance
• Identifies and communicates best practices and lessons learned to drive continues improvement in processes and tools for performance of site management oversight activities
• Serves as knowledge source on processes related to trial deliverables and coordinates knowledge sharing
• Provides input to TMM headcount forecasts to support trial deliverables and collaborates with POLs to ensure efficient and transparent allocation of resources to support trial deliverables
• Provides guidance to TMMs on the development of trial execution plans (e.g. site initiation/ activation plan, site management oversight plan, monitoring plan, etc.), resolving trial issues and implementing corrective/ preventive measures during trial conduct
• Oversees operational quality and compliance of TMM activities
• Participates in vendor governance meetings to monitor and address performance issues and escalation/ resolution of issues related to site management encountered by the TMMs
• Coordinates responses to inspection/ audit findings at functional level in conjunction with Quality Assurance
• Supports TMMs in inspection readiness activities and attends Health Authority inspections to manage and answers request from the inspectors
• Acts as Subject Matter Experts for SOP development/ updates or training

• Bachelor's Degree or equivalent qualification in life science/ healthcare required, Master's Degree preferred
• Ideally eight or more years of pharmaceutical clinical research experience
• Ideally three or more years people management and development experience, this may include management in a matrix environment
• Strong management, interpersonal and problemsolving skills
• Demonstrated leadership and accomplishment in all aspects of conducting global clinical trials
• Extensive knowledge of clinical development process, regulatory requirements and GCP
• Proven capabilities in clinical operations process improvements
• Considerable organizational awareness, including significant experience working crossfunctionally and responsibility for internal resource estimation/ allocation
• Experience with internal budget accountability for direct reports

• Flexible working models
• Attractive working in crossfunctional teams
• Open and appreciative culture
• Multicultural environment with the brightest and most innovative people
• Working in an attractive, highquality building with a top notch restaurant
• Attractive benefits for wellbeing (financial and nonfinancial), recognition and development
• International Development opportunities