Trial Operations Manager (NOVJP00025977) (m/f)

REFERENZNUMMER:

370310/11

IHRE AUFGABEN:

-Under the direction of TOM Development Unit Head, you are accountable for the oversight and coordination of the global monitoring operational aspects of assigned clinical trials, from start-up to close-out, in collaboration with GCT/ICT/CTTs, regions and countries (COs), in compliance with Novartis processes, GCP, ICH and regulatory requirements
-Participate in the development of innovative solutions in clinical trial planning and execution, including country, site and patient engagement to ensure the delivery of assigned studies on time
-Develop planning for prospective management of clinical trials including operational risks for each phase of the trial (Feasibility/allocation, Start-up, Data collection and Cleaning) using available internal and external resources
-Review, approve, and ensure updates to CCGs as appropriate during trial conduct
-Perform User Acceptance Testing for EDC system
-Ensure timely site close-out activities, in coordination with CTT and COs (with Clinical

Study Managers)

IHRE QUALIFIKATIONEN:

-Extensive experience in clinical research, in planning/executing and/or monitoring clinical trials
-Solid understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, project management and operations
-Demonstrated ability to collaborate across partner functions in a matrix environment, without direct reports, but can coordinate the activities of others
-Project/trial management and/or CRA or CRA management, Clinical Study Managers experience preferred
-Proven ability to manage operational challenges at global, regional or country level for large complex trials with minimal supervision
-Excellent project management capabilities with demonstrated ability to problem solve and mediate complex issues
-Communicates effectively with senior leaders in a local/regional/global matrixed environment

WEITERE QUALIFIKATIONEN:

Clinical project manager