Clinical Research Associate Manager

Job Description Summary

In this role you will oversee CRA performance, develop and coach CRA's to drive mindset and behaviour. The CRAM is responsible for managing and addressing CRA performance targets per defined KPIs: delivery, productivity, and quality performance indicators, including managing site recruitment commitments, timely data entry and issue resolution. Ensures CRA monitoring competency gaps are identified and resolved through targeted coaching and training curricula in collaboration with training group and through co-monitoring visits and liaises ongoing basis with CPMs to ensure enrolment, data collection and data cleaning are executed by CRAs in a timely manner.

 

Job Description

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.

 

Skills Desired

Budget Management, Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trials, Collaboration, Data Analysis, Decision Making Skills, Health Sciences, Lifesciences, People Management, Regulatory Compliance