Key responsibilities:

• In collaboration with SSO Clinical Project Manager (CPM), supports recruitment strategies and site performance by ensuring high quality and compliance of monitoring activities

• Is accountable for monitoring quality, timely data entry and issue resolution

• Ensures CRA monitoring competency gaps are identified and resolved through targeted training curricula in collaboration with training group as well as by performing co-monitoring visits with training purposes

• 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 manage CRA team performance including implementation of development and performance improvement plans

• Supports implementation of Risk Based Monitoring in GCO clinical trials by coaching and training CRAs on process thinking, risk-based monitoring concept and related systems

• Is responsible for execution of annual CRA oversight visit plan to assess ongoing CRA monitoring competency, identifying issues, and developing resolution strategies

• Collaborates with CPM for monitoring trends that require targeted training and/or development of CRAs to deliver to trial and quality KPIs

• Collaborates with MSOM for country resource strategy

• Ensures adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements

• Supports Clinical Development Audits, site audits and inspection and ensures CAPA follow-up and implementation for CRA and site identified issues

• Manages CRA adherence/compliance to SOPs and required training curricula

• Is responsible for the hiring, training, development, and retention of a team of CRAs executing Phase I-IV Global Drug Development (GDD) trials

• Performs ongoing assessment and allocation of monitoring resources within countries to ensure balanced CRA workload for quality monitoring

• Ensures CRAs have the required level of monitoring and disease area knowledge and skills to successfully deliver to protocol requirements

• Monitors, tracks and approves CRA travel and expense to ensure compliance to T&E policy and budget

Essential requirements:

• A degree in scientific or health discipline required and advanced degree preferable (or, for United States: 4-year degree plus relevant, related healthcare experience)

• Fluent in both written and spoken English

• Minimum 7 years’ experience in clinical research - planning/executing and/or monitoring clinical trials

• Experience in project management and evidence of team leadership capabilities

• Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution

Desirable requirements:

• Decision making capability

• Excellent site management capabilities with demonstrated capability to problem solve and mediate complex compliance issues.

• Excellent coaching capability to best support CRA in driving right mindset and behavior

• 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, risk-based monitoring and Novartis standards

• Demonstrated negotiation and conflict resolution skills

• Fast change adaptability to best partner & influencing with sites on fast changing landscape

• Trust and rapport building is a very important skill needed

• Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings.

• Good communication skills, ability to influence others & Relationship management

• Excellent communicator and presenter (oral and written)

• Ability to manage sites independently; Proven ability to work independently with minimal supervision

• Good analytical thinking

• Ability to anticipate potential issues and take appropriate actions with or without supervision

• Digital & tech capabilities