Study & Site Operations Head

1 week ago

Montréal, Canada Novartis Full time

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 #GCO
- The SSO Country Manager 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 SSO Country Manager is responsible for implementing the Study & Site archetype and Hub/Cluster/Country strategy, while delivering to Country budget and productivity targets in line with Study & Site and local business objectives. Operationally responsible for building a high performing team culture and including performance management and established monitoring procedures in accordance with GCP, ICH and local regulations.
- Your key responsibilities:
- Drive 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
- Leverage innovation in clinical trial planning and execution, including patient engagement as appropriate to deliver recruitment goals
- Align the OPC objectives with the broader Study & Site Operations objectives
- Collaborate 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)
- Oversee 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
- Engage and aligns with SSO Cluster Head Portfolio to ensure delivery in the clinical trial program
- Establish a process for managing performance (recognition/corrective action) to ensure OPC country structure delivery to the established Key Performance Indicators (KPI) / Key Quality Indicators (KQI)
- Ensure OPC country delivers clinical trials by identification of new sites to establish Novartis as a preferred clinical research partner
- Develop an understanding of the prevailing legislation, GCP, Ethical Committee, and SOP requirements within the OPC country structure
- Ensure that the studies under responsibility are conducted as per current legislations, ICH/GCP and Novartis standards
- Actively monitor 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
- Ensure issues are escalated, manages escalated issues, if quality issues dictate and supervises resulting CAPAs
- Monitors adhere/compliance to SOPs and required training curricula per GDD targets
- Drive continuous improvement in quality data and compliance and fosters best practice sharing within and across the OPC Country structure
- Responsible for local Study & Site Operations SOPs creation and lifecycle management as well as implementation of all relevant country rules and regulations

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve._

**Minimum requirements**
- Desirable criteria:
- 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
- Superior leadership skills, strategic thinking, and ability to influence without direct authority
- Proven ability to lead managers, teams and complex communication locally and in the global organization with strong understanding of project management methodology as well as strong understanding of the structures and roles and responsibilities of personnel working in the GDD organization
- Expert understanding of all aspects of clinical drug development with particular emphasis on trial execution and monitoring
- Excellent site management capabilities with demonstrated negotiating and problem-solving skills including financial management
- At least 10 years’ experience in clinical research - planning/executing and/or monitoring clinical trials with minimum 4 years in a people management role
- Bachelor’s Degree in life sciences required; Advanced Degree in scientific or business preferred

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 exten

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