100,000+ That's how many patients participate in our clinical trials at any given time. GCO is Novartis' powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine - imagine the impact you could have as the SSO Country Manager! #GCO
This is a completely new and exciting strategic opportunity where enterprise, agility, autonomy, quality and superior clinical operation activities! We need an individual who can allocate, initiate and conduct timely completion of Phase I-IV Oncology and Pharma clinical trials. You will be working with your Director to ensure alignment on portfolio strategy, prioritization and performance for an excellent GDD trial delivery. So, if you thought leader who instils the highest value for our patients, can implement a Study & Site and Hub/Cluster/Country strategy to a Country budget, wants to continue our family trusted environment and with a goal to reduce cycle time and reduce costs excites you, then you should apply.
Your key responsibilities:
• Implements the defined Study & Site Operations and OPC country structure monitoring strategies to deliver country business and trial strategy objectives in close collaboration with the SSO Cluster Head Portfolio, Clinical Research Associate (CRA) Manager and Country CSO and Medical Director.
• Aligns Country monitoring objectives to the SSO Country Head (OPC) and country CSO/Medical Director.
• Responsible for the alignment between SSO Feasibility Manager and relevant medical/clinical functions to ensure strategic allocation and execution of global development trials within the Country (Innovative Medicines Phase I-IV trials).
• Drives collaborative engagement model with Cluster Head Portfolio to ensure Country participation in GDD trials is aligned with the overall OPC Country structure portfolio execution strategy.
• Actively monitors the KQI's and develops, maintains and follows-up on the yearly process control plan in the Country to ensure adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements.
• Manages Country budget and Monitoring headcount allocation to target in close collaboration with Country Head (OPC) (as appropriate).
• Identifies, documents and shares Country productivity initiatives in line with Study & Site productivity goals.
• Responsible for the local development vendor identification, contracting, oversight and management.
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What you'll bring to the role:
• Expert understanding of all aspects of clinical drug development with particular emphasis on trial execution and monitoring
• Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards.
• Excellent negotiation and conflict resolution skills
• Excellent organisational, interpersonal skills with extensive networking expected
• Excellent communicator and presenter (oral and written), ability to communicate to Sr. Leaders
• Bachelor's Degree in life sciences required; Advanced Degree in life sciences or business preferred
• Fluent in both written and spoken English
• Minimum 8 years' experience in clinical research - planning/executing and/or monitoring clinical trials with minimum 4 years in a people management role
766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could achieve here at Novartis!
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message. #GCO