Job Description

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 SSO Portfolio Team Lead! #GCO

This position is open to applications in Singapore, India, Australia, South Korea & Taiwan.

The SSO Portfolio Team Lead is responsible for the Clinical Project Managers (CPMs), SSO Feasibility Managers and SSO Site Partnership Managers and their study specific activities, including the hiring, training, development, and assignment to ensure adequate and timely portfolio execution. The SSO Portfolio Team Lead assures that CPMs coordinate their activities across all CRAs working on the same trials/projects in collaboration with the CRA Managers/FSP line managers.
The SSO Portfolio Team Lead is responsible for CPMs, SSO Feasibility Managers and SSO Site Partnership Managers compliance of study management activities and for the delivery of study milestones, in close collaboration with the CRA Mangers/ FSP line managers and aligned with Global and local medical strategy, in the country/OPC country structure. The Portfolio Team Lead is responsible for overall portfolio execution related performance (KPIs), ensuring the study milestone deliverables, in accordance with GCP, ICH, SOP\'s, and local regulations.

Portfolio Execution strategy:

• Collaborates with Country Head, Country/Cluster Portfolio Head and CRA Managers/FSP line managers to implement country innovative practices and patient engagement tactics (as appropriate) to advance clinical trial planning, execution and quality in line with Portfolio Execution country/OPC country leadership
• Identifies and leads innovative solutions to further advance the Project Management in GDD portfolio, in collaboration with Study & Site Operations country/OPC country leadership

Allocation, initiation and conduct of trials:

• Develops opportunities in collaboration with SSO Feasibility Manager, SSO Site Partnership Manager, Country/Cluster Portfolio Head and relevant medical/clinical functions to build a competitive advantage for GDD trials within the country/OPC country, ensuring alignment with the local medical standard of care, local business drivers and site relationship management

Delivery of quality data and compliance to quality standards:

• Collaborates with Clinical Research Associate (CRA) Manager to ensure that monitoring trends that require targeted training and/or development are escalated.
• Coordinates between the Clinical Research Associate (CRA) Manager, CPM and SSO Site Partnership Manager to ensure that site issues, data flow and commitment deviations are addressed and escalated.

Management of people and resources management:

• Is responsible for the hiring, training, development, and retention of a team of Clinical Project Managers (CPMs), SSO Feasibility Managers and SSO Site Partnership Managers to ensure study milestones are delivered for the Innovative Medicines Phase I-IV Global Drug Development (GDD) trials
• Together with the country/cluster Portfolio Head performs ongoing assessment and allocation of CPMs, SSO Feasibility Manager and SSO Site Partnership Manager resources within Country/OPC Country/Hub to ensure balanced workload

Budget and productivity:

• Ensures country study budgets (Trial Commitment Forms, TCFs) are managed per established study key performance indicators and study objectives
• Ensures study milestones to allow timely payments to stakeholders (invoiceable items and vendors) for clinical trial activities

Activities & Interfaces:

• Collaborates with the SSO Site Partnership Manager and relevant medical/clinical functions to enhance Novartis relationship with clinical sites
• Coordinates between the Clinical Research Associate (CRA) Manager, CPM and SSO Site Partnership Manager to ensure that site issues, data flow and commitment deviations are addressed and escalated

Minimum requirements

• A degree in scientific or health discipline required and advanced degree with experience in project management, is preferable
• Minimum 8 years\' experience in clinical research and/or project management and evidence of team management and leadership capabilities; 4 years of people management experience
• Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution
• Excellent project management capabilities with demonstrated capability to problem solving and mediate complex compliance issues
• 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

Functional Area

Research & Development

Division

Global Drug Development

Business Unit

GDO GDD

Employment Type

Regular

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.

Shift Work

No

Early Talent

No

Novartis