Job Description

Job Purpose:
Accountable for the oversight and coordination of program and study level (re-)feasibility assessments in the country or extended country group (OPCs & satellite countries), in collaboration with program and/or trial feasibility teams, in compliance with Novartis processes, GCP, ICH and regulatory requirements. This position is key to establish good communication and professional relationships with clinical investigators and company stakeholders on country/cluster/hub/global level.
Closely collaborates with rest of Study & Site Operations and relevant medical/clinical functions to ensure successful allocation, realistic country targets, recruitment according to planned timelines, early identification of risks and opportunities as well as potential delays and mitigation plan.
Accountabilities What are the key deliverables and accountabilities of the role?

• Single point of contact for communication between Clinical Operations Program Manager/Clinical Operations Program Head, country/extended country group Study & Site Operations teams and local relevant medical/clinical functions for all requests for program/study feasibility
• Coordinates the feasibility activities on country/extended country group level by ensuring:

o Site identification and selection, trial feasibility evaluation
o Collates/validates the list of potential sites by utilizing internal and external data (e.g., historical data, individual knowledge within local Study & Site Operations Team and relevant medical/clinical functions, internal and external databases)
o Manages the study specific feasibility questionnaire and sends to all participating sites together with any supporting documentation, if applicable
o Follows up with sites to ensure questionnaires are answered and any additional feedback is obtained
o Assess the clinical feasibility of implementing a clinical trial protocol based on regional/local medical practice using physician interviews, local databases (RWE, payer data, patient association feed-back, etc.) and analysis of the competitive environment
o Enters feedback into global database if applicable (e.g., CLIP). Collects, analyses, and interprets data to provide comprehensive proposals and timelines for country / extended country group allocation of clinical programs and assigned trials.

• Responsible for early identification for potential risks and opportunities as well as potential synergies and back-up strategies within the country/extended country group. Closely collaborates with the Study & Site Operations to ensure fast clinical trial start up, recruitment according to planned timelines, early identification of potential delays and robust recruitment mitigation plan. Co-own start-up phase and the recruitment plan for development clinical trials with the Study & Site Operations organization.

Minimum requirements

Education:
Scientific degree and advanced degree with clinical trial experience and/or project management, is preferable
Languages:

• Fluent in both written and spoken English

Experience/Professional requirement:

• Minimum 5 years\' experience clinical development experience in pharmaceutical industry
• Capable of leading in a matrix environment, without direct reports and working cross-border
• Ability to manage a study from the medical/clinical perspective, and a demonstrated capability to problem solve and mediate complex-clinical / medical / operational issues

Functional Area

Research & Development

Division

Global Drug Development

Business Unit

GCO 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