About This Role
This role is critical for ensuring robust monitoring in clinical trials, overseeing a team of 6-14 Clinical Research Associates (CRAs) to achieve excellent study and site performance while strictly adhering to local regulations, company SOPs, and ICH GCP. As an Associate Director, the position focuses on developing key talents through training, support, and mentoring for CRAs, and effectively managing performance issues. The role involves country-level collaboration with local stakeholders like Clinical Research Managers (CRM) to align and develop country capabilities, and with Partner Line Managers (PLMs) to ensure consistency across all monitoring functions. The person will also contribute to HQ capacity/resource planning for efficient allocation of resources and work, primarily in Vaccine/Infectious Disease with some Cardiovascular therapeutic areas.
Responsibilities
- Allocate work, support staff development, and conduct performance appraisals
- Support departmental company initiatives and work streams
- Provide input for capacity planning, including reporting current manpower and forecasting CRA capacity and needs for efficient resource use
- Work with CRAs, PLMs, and other functions to ensure consistency of processes and protocol implementation across the country, reducing variability and providing predictability
- Interact with sites as needed to resolve site or CRA operational issues to meet commitments in a timely manner, 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 Head of Site Management and Monitoring
- Manage CRA career development and performance reviews, including addressing low performance situations and taking appropriate actions
- Support and resolve escalation of issues from CRAs
- Liaise with local HR and finance functions as required
- Contribute to HQ capacity/resource planning activities to ensure efficient allocation of resources and work
- Manage local conflicts between resource and work
- Provide training, support, and mentoring to CRAs to ensure continuous development
- Ensure CRA compliance with corporate policies, procedures, and quality standards
Requirements
- Minimum of 5 years’ experience within Clinical Research
- Minimum of 3 years’ experience as a CRA monitoring clinical trials
- Bachelor’s degree
- Ability to work independently and in a team environment
- Excellent people management, time management, project management, and organizational skills
- History of strong performance
- Skills and judgment required to be a good steward/decision maker for the company
- Fluent in local language and business proficient in English (verbal and written)
- Excellent working knowledge of all applicable ICH/GCP regulations and Good Documentation Practices and ability to work within these guidelines
- Expertise in and excellent working knowledge of core trial management systems and tools
- High emotional intelligence
- Strong leadership skills with proven success in people management
- Excellent interpersonal and communication skills, conflict management
- Demonstrated ability to build relationships and to communicate effectively with external customers (e.g., sites and investigators)
- Influencing skills
Nice to have:
- Line management experience or at minimum team leader experience
About the Company
This role is within a company that conducts clinical trials, focusing on Vaccine/Infectious Disease and Cardiovascular therapeutic areas.
