Global Trial Leader NOVJP00026542 (m/f)

REFERENZNUMMER:

377385/29

IHRE AUFGABEN:

-Partners and agrees with GPT/GCT/ICT/CTT on trials execution plans and timeline Commitments in alignment with Trial Monitoring strategy and on behalf of the Trial Monitoring organization to achieve global and regional/local business. Communicates planned milestones to Trial Monitoring stakeholders and update GCT/ICT/CTTs on Operational activities at the Region/CO level, during the course of the trials to meet GPT Objectives
-Participates 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
-Actively participates in the development of reporting methodologies, and implements Performance reporting for trial monitoring, ensures accurate and complete operational Data within corporate systems (i.e CTMS, IMPACT)
-Drives conduct of medical and operational feasibilities and communicates aggregated Feedback to clinical teams; supports protocol development based on the feasibility Feedback collected, ensures feedback given during feasibility process is answered and Provided to regions and COs. Evaluates potential challenges/risks within the protocol and operational aspects of the study; assessing impacts, developing risk management plans and communicating/escalating, as appropriate

IHRE QUALIFIKATIONEN:

-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
-Thorough knowledge of the international aspects of drug development process, the international standards (GCP/ICH), health authorities (FDA/EMEA), local/National health authorities regulations, Novartis standards, and clinical development process
-Understand and apply medical and business knowledge to clinical trial execution
-Excellent negotiation and conflict resolution skills
-Demonstrated ability to influence without direct authority
-Excellent organizational, interpersonal skills with extensive networking expected
-Communicates effectively with senior leaders in a local/regional/global matrixed environment

WEITERE QUALIFIKATIONEN:

Clinical project manager