Global Clinical Operation Leader (m/f)

SANDOZ
Division SANDOZ
Geschäftseinheit BioPharma SZ
Standort Holzkirchen (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 250430BR


Stellenbeschreibung

• Provide global clinical operational input into Clinical Development Plans, Program-level Operational Plans, and Trial Execution Plans
• Conduct program level planning to establish global resource requirements and high-level recruitment strategies
• Determine outsourcing strategy of program in conjunction with Clinical Development Heads and global cross-functional teams
• Ensure timely and efficient operational execution of clinical trials in accordance with Clinical Development Plans (CDPs), Program-level Operational Plans, and Trial Execution Plans
• Management of resources across programs in collaboration with the Head of Clinical Operations to ensure efficient resource utilization including coordination of headcount requests and resource alignment with other line functions
• Provide oversight on operational quality and compliance in conjunction with Clinical Quality Assurance; ensure inspection readiness of assigned programs, and coordinate/lead responses to audit /inspection observations at the program level
• Support study teams during regulatory inspections including QC of document requests, development of response strategies and attendance at interviews if required
• Line management of assigned Clinical Trial Leaders
• Author/reviewer for Clinical SOPs
• Participate in Clinical Operations Meeting and/or cross-functional forums to exchange information, best practices, and discuss issues



Research & Development


Mindestanforderungen

• Master’s Degree/PhD and 7 years relevant experience preferred or Bachelor’s Degree plus 9 years relevant experience
• Significant trial management experience
• Extensive knowledge of clinical development process, regulatory requirements and GCP
• Strong team leadership skills
• Experience with FDA or EMEA inspections.
• Line management experience preferred
• Excellent supervisory, organizational and communication skills

We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.
Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.



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