Accountabilities:
Portfolio execution strategy

• 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
• Identifies and implements innovative practices and patient engagement strategies in collaboration with Clinical Research Associate (CRA) Manager, Country CSO and Medical Director within the country to advance clinical trial planning, execution, and quality

Delivery of quality data and compliance to quality standards

• 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

• Is responsible for Country Monitoring issue identification, escalation and resolution pathways

in CPO, partnering with relevant medical/clinical functions, Country QA, GLF’s and Dev QA

• Actively manages Country issue identification and resolution in relation to CPO and trial audits,

inspections and delivers to CAPA implementation requirements

• 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

• Is accountable for Country adherence/compliance to SOPs and roll-out/adoption across the

Country Study & Site structure for required training curricula per GDD targets

• Responsible for local Study & Site SOPs creation and lifecycle management as well as

implementation of all relevant country rules and regulations

• Drives continuous improvement in Monitoring operations and fosters best practice sharing

within the Country

• Primary contact for FSP/Bi S vendors to ensure overall quality & performance
• Responsible for escalation and follow-up of non-performance issues to FSP/Bi S line managers

Management of people and resources management

• Along with FSP/Bi S line manager is responsible for selection of CRAs, Study Start-up CRAs and

enabling function associates

• Along with FSP/Bi S line manager participates in the allocation of the field-based resources

within the country in alignment with Country Head (OPC) (as appropriate)

• Develops performance management processes to proactively manage key performance and

quality indicators to ensure achievement of Country/OPC Country performance targets

• Is responsible to implement and adopt global training strategy, tools/systems and processes

within the country and ensure country training needs are communicated to Global Training

Budget and productivity

• 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

Activities & Interfaces
Interfaces with GMA and Commercial organization within country to ensure aligned
portfolio strategies across the business

• Partners with OPC S&O and OPC Portfolio teams to drive resourcing and allocation

strategies and track execution to established timelines.

Ideal Background:
Education:

• Bachelor’s Degree in life sciences required; Advanced Degree in life sciences or business preferred

Languages:

• Fluent in both written and spoken English

Experience/Professional requirement:

• Minimum 8 years’ experience in clinical research - planning/executing and/or monitoring clinical trials with minimum 4 years in a people management 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

Competencies:

• Leadership, strategic thinking and matrix management skills
• Established track record of leading successful teams

Skills & Knowledge:

• 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