Associate Director, Clinical Research Associate Manager

Overview

Manage a team of 6-14 Clinical Research Associates (CRAs) to ensure strong monitoring and excellent study and site performance in clinical trials, under the oversight of the CRD or Head of Site Management and Monitoring.

What you'll do

• Manage work allocation, staff development and performance appraisal for CRAs.
• Manage CRA career development and performance reviews, including addressing low-performance situations and taking appropriate actions.
• Support and resolve escalations of issues from CRAs.
• Provide training, support and mentoring to CRAs to ensure continuous development.
• Provide input for capacity planning, including reporting current manpower and forecasting CRA capacity and needs.
• Contribute to HQ capacity and resource planning activities and manage local conflicts between resource and work.
• Work with CRAs, PLMs and other functions to ensure consistency of processes and protocol implementation across the country.
• Interact with sites as needed to resolve site or CRA operational issues in coordination with the study CRM.
• Attend local Investigator Meetings if requested.
• Interface with GCTO partners on clinical trial execution.
• Escalate site performance issues to the CRM and Clinical Research Director (CRD).
• Liaise with local HR and finance functions as required.
• Ensure CRA compliance with corporate policies, procedures and quality standards.

What you'll need

• Master's in science, Master's in Pharmacology, Pharmacy or Clinical Research.
• Fluent in the local language and business proficient in English (verbal and written).
• Excellent working knowledge of all applicable ICH/GCP regulations and Good Documentation Practices.
• Expertise in and excellent working knowledge of core trial management systems and tools.
• Excellent people management, time management, project management and organizational skills.
• Strong leadership skills with proven success in people management.
• History of strong performance.
• Ability to work independently and in a team environment.
• Excellent interpersonal and communication skills, including conflict management.
• Demonstrated ability to build relationships and communicate effectively with external customers (e.g. sites and investigators).
• Influencing skills and high emotional intelligence.
• Skills and judgment to be a good steward and decision maker for the company.

Details

• Location: Mumbai, Maharashtra, India (WeWork).
• Travel requirements: Flexible.
• Required skills include Clinical Research Management, Clinical Trials Monitoring, Good Clinical Practice (GCP), Line Management, Oncology Trials, People Leadership, Performance Feedback and Policy Compliance, among others.