CRA Manager at Novartis

Job Description

The Clinical Research Associate (CRA) Manager is responsible for the hiring, training, development and assignment of CRAs to ensure qualified Monitoring resource assignment to the Global Drug Development (GDD) portfolio. The CRA Manager is responsible for CRA (Trial Monitoring and external) quality and compliance of clinical monitoring activities related to investigator site qualification, initiation, and trial conduct (recruitment, quality data collection). The CRA Manager is responsible for CRA performance to KQI’s, ensuring implementation and appropriate application of established Monitoring procedures and tools in accordance with GCP, ICH, SOP’s, and local regulations.

Major Accountabilities:

Trial Monitoring strategy

• Collaborates with Trial Monitoring Country Head, Cluster Head or Development Unit Head to implement country innovative practices and patient engagement tactics (as appropriate) to advance clinical trial planning, execution and quality in line with Country CSO and Medical Director strategies
• Develops investigational site territory by identifying and qualifying new sites for participation in GDD portfolio in collaboration with Country/Cluster/Development Unit Head and, Country CSO/Medical Director

Allocation, initiation and conduct of trials

• Is strategically and operationally involved in allocating new trials in collaboration with Country/Cluster/Development Unit Head and local CSO/Medical Director teams during trial feasibility/allocation
• Ensures country trial site selection, activation, enrolment, data flow and timeline commitments are delivered per established Trial Monitoring KPI’s trial objectives
• In collaboration with CSMs, reviews the status of planned versus actual patient recruitment and supports implementation of strategies to correct deviations from proposed plan enrolment according to monitoring procedures
• Liaises with local and global TA/BU clinical teams (e.g. escalates unresolved site issues) to enhance Novartis relationship with clinical sites, to ensure site performance to trial commitments and delivery of quality monitoring

Delivery of quality data and compliance to quality standards

• Is accountable for monitoring quality and issue resolution through timely review and approval of study monitoring visit reports to ensure quality trial oversight and appropriate issue escalation/resolution
• Ensures CRA monitoring competency gaps are identified and resolved through targeted training curricula in collaboration with local training and Trial Monitoring Excellence group
• Is responsible for execution of annual Field Monitor Accompanied Visit Plan to assess ongoing CRA monitoring competency, identifying issues and developing resolution strategies in collaboration with local or Trial Monitoring Excellence
• Collaborates with Clinical Study Manager (CSM) Manager for monitoring trends that require targeted training and/or development of CRAs to deliver to trial KPI and KQI goals
• Ensures adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
• Supports CPO / site audits and inspection and ensures CAPA follow-up and implementation for monitor and site identified issues
• Manages CRA adherence/compliance to SOPs and required training curricula

Management of people and resources management

• Is responsible for the hiring, training, development and retention of a team of CRAs to deliver quality monitoring to the Innovative Medicines Phase I-IV Global Drug Development (GDD) trials
• Performs ongoing assessment and allocation of monitoring resources within Country, Cluster or Development Unit to ensure balanced CRA workload for quality monitoring
• Ensures CRAs have the required level of Monitoring and Development Unit (disease) area knowledge and skills to successfully deliver to protocol requirements
• Is responsible for managing and addressing CRA performance targets per defined Trial Monitoring key trial and quality performance indicators, including managing site recruitment commitments, timely data entry and issue resolution

Budget and productivity

• Monitors, tracks and approves CRA travel and expense to ensure compliance to T&E policy, and to ensure within local targets for monitoring visits budget (as appropriate)

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.

Minimum Requirements

A degree in scientific or health discipline required and advanced degree preferable

• 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
• Excellent site management capabilities with demonstrated capability to problem solve 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/EMEA), local/National Health Authorities regulations and Novartis standards
• Demonstrated negotiation and conflict resolution skills
• Communicate effectively with site personnel, country and global associates