Trial Monitoring Country Head Germany (m/f/d) Unbefristet, Vollzeit
Job Description 200! That is the number of studies we conduct in Germany every year!
Novartis is a global pharmaceutical company. Our goal is to redefine medicine in order to improve and prolong people's lives through the application of innovative science and technology.
We are committed to development - developing innovative compounds that serve the needs of a growing, aging population and developing new and innovative ways to reach people in low-income countries.
We invest in the most promising areas of science, in the most exciting innovations in the medical field, and in the most important needs of health care.
We are convinced that the best solutions are found in a team!
We are Novartis. Join us and help us reimagine medicine.
Within this very innovative environment we are currently hiring the
Trial Monitoring Country Head Germany (m/f/d)
The Country Head is accountable for all Country clinical operation activities related to the allocation, initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials. The Country Head is responsible for implementing the Trial Monitoring archetype and Regional/Country strategy, while delivering to Country budget and efficiency targets in line with Trial Monitoring and local business objectives. Is operationally responsible for building a robust team culture and ensuring standardization across Development Units - including talent development, performance management and established monitoring procedures in accordance to GCP, ICH and local regulations.
Responsibilities include but are not limited to:
Trial Monitoring strategy
• Defines and drives Country Trial Monitoring strategy to achieve Regional/Country business and trial strategy objectives in close collaboration with Regional Head of Trial Monitoring, Country CSO and Country Medical Director
• Aligns Country monitoring objectives to global Trial Monitoring, Regional Trial Monitoring and Country CSO/Medical Director
Allocation, initiation and conduct of trials
• Defines and implements Country (Regional, where applicable) feasibility strategy to ensure strategic allocation and execution of global development trials within the Country (Innovative Medicines Phase I-IV)
• Finds opportunities to build competitive advantage for global development trials within the Country by identifying trial level alignments for medical standard of care, local business drivers and site relationship management
Delivery of quality data and compliance to quality standards
• Actively supervises quality KQI’s in the country to ensure adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
• Is responsible for country monitoring issue identification, customer concern and resolution pathways in CPO, partnering with Country Medical, Country QA, GLF’s and DevQA
• Management of people and resources management
• Is responsible for hiring, development and retention of talent including Trial Monitoring TA Heads, CRA/CSM management and enabling functions
• Is responsible for the allocation of Trial Monitoring office and field based resources within the Country Monitoring structure in collaboration with Trial Monitoring Regional Head and local Medical organization (as appropriate)
Budget and productivity
• Is responsible for Country budget and headcount allocation to achieve targets in co-operation with Region Head, Region Finance, Global Trial Monitoring and local Medical organization (as appropriate)
Art des Stellenangebotes:
Minimum requirementsWhat you’ll bring to the role:
• Bachelor’s Degree in life sciences required; Advanced Degree in scientific or business preferred
• Minimum 10 years’ experience in clinical research - planning/executing and/or monitoring clinical trials with minimum 4 years in a people management role
• Detailed understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis standards
• Proficient in both written and spoken English, local language as needed in clusters/countries
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, fearless and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks. And where you’re surrounded by people who share your determination to seek the world’s toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to build an inclusive workplace that cultivates ambitious innovation through collaboration, and empowers our people to unleash their full potential.
Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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