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 is accountable for all clinical operation activities related to the allocation, initiation, conduct and timely completion of Phase I-IV Oncology and Pharma clinical trials within an OPC country structure. So, if want to continue in our family trusted environment, deliver data within timelines and required quality standard, budget and implement monitoring procedures in accordance with GCP, ICH and local regulations, thrive with performance, and with a goal to reduce cycle time and reduce costs excites you, then you should apply.
Your key responsibilities:
Drives Study & Site Operations strategy to achieve required business objectives in close interaction with the SSO Cluster Head, SSO Country Managers (Satellite Countries) and relevant medical/clinical functions
Leverages innovation in clinical trial planning and execution, including patient engagement as appropriate to deliver recruitment goals
Aligns the OPC objectives with the broader Study & Site Operations objectives·
In collaboration with the SSO Cluster Head Portfolio and the SSO Feasibility Manager, defines the OPC country feasibility strategy to optimize the execution in global development trials (Innovative Medicines, Phase I-IV clinical trials)
Oversees the delivery of trials within the OPC country structure to optimize the mix of clinical trials according to short- and long-term needs defined by global, Cluster/Hub strategies to meet enrolment commitment, timelines, and budget
Engages and aligns with SSO Cluster Head Portfolio to ensure delivery in the clinical trial program
Develops an understanding of the prevailing legislation, GCP, Ethical Committee, and SOP requirements within the OPC country structure
Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times
Actively monitors the development, maintenance and execution of the yearly process control plan to ensure adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum requirements
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
Desirable requirements:
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
Why Novartis?
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
Division
Global Drug Development
Business Unit
GDO GDD
Country
Czech Republic
Work Location
Prague
Company/Legal Entity
NOV CZE
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No