Clinical Research Associate Manager

This position is a field based position in the UK. Novartis can not offer relocation for this position. Please only apply if the country location suits you.

Key responsibilities:

• Responsible for the hiring, training, development, and retention of a team of CRAs executing Phase I-IV Global Drug Development (GDD) trials
• Ensure CRAs have the required level of monitoring and disease area knowledge and skills to successfully deliver to protocol requirements
• Promote 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
• Manage CRA adherence/compliance to SOPs and required training curricula
• Collaborate with the MSOM for country resource strategy
• Support Clinical Development Audits, site audits and inspection and ensures CAPA follow-up and implementation for CRA and site-identified issues
• Deliver of high-quality clinical data ensuring adherence to prevailing legislation, GCP, Ethical Committee and SOP requirements
• Deliver of trial monitoring to agreed measures of CRA performance, productivity and quality

Essential criteria:

• Significant experience in the delivery of clinical research; planning/execution/monitoring of clinical trials.
• Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution
• Experience in project management and evidence of team leadership capabilities

Desirable criteria:

• Demonstrated negotiation and conflict resolution skills
• Adaptability to best partner with sites in a fast-changing landscape
• Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings

Education:

• Degree in scientific or health discipline preferred, advanced degree preferred.