Associate Director

MSD

Selangor

On-site

MYR 240,000 - 320,000

Full time

4 days ago
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Job summary

MSD Malaysia seeks an Associate Director (CRAM) to lead a team of 6-14 CRAs, ensuring robust monitoring of clinical trials in Malaysia. Reporting to the CRD or Head of Site Management and Monitoring, the role requires strict adherence to local regulations, SOPs and ICH GCP.

You will train and mentor CRAs, manage performance, and collaborate with country PLMs and HQ capacity planning to optimize resources and ensure consistent protocol execution across the country.

Qualifications

  • Minimum 5 years in Clinical Research.
  • Minimum 3 years of CRA monitoring experience.
  • Line management or team-leader experience preferred.
  • Bachelor's in science or higher with emphasis in science/biology.

Responsibilities

  • Oversee staff allocation, development, and performance appraisal.
  • Coordinate CRA capacity planning and resource forecasting.
  • Ensure compliance with ICH/GCP and company policies across country.
  • Interface with sites, investigators, and external partners.
  • Provide training and mentoring to CRAs to improve performance.
  • Collaborate with country PLMs and HQ capacity planning.

Skills

Leadership
People management
Communication
Project management
Time management
Organizational skills
Conflict management
Stakeholder engagement
English proficiency

Education

Bachelor's degree in science
Advanced degree in science/biology

Tools

Trial management systems

Job description

Jora Malaysia will close on 9th September 2026. Thank you for being with us, we are cheering you on as you continue your career journey.

This Associate Director (CRAM) will be key to ensure strong monitoring in our clinical trials. Under the oversight of the CRD or Head of Site Management and Monitoring, the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations, company SOPs and ICH GCP.

As line manager the role is critical to continuously develop key talents by providing training, support and mentoring to the CRAs and properly manage situation of low or non-performance.

The role will work at country level with other local stakeholder to ensure alignment and development of the country capabilities. The role will collaborate with country PLMs to ensure alignment across all monitoring functions. The person contributes to HQ capacity/resource planning activities to ensure efficient allocation of resources and work.

Responsibilities include, but are not limited to:
  • Work allocation, staff development and performance appraisal.
  • Provides input for capacity planning, including reporting of current manpower and forecasting of CRA capacity and needs, to provide efficient use of resources.
  • Work with CRAs, PLMS and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.
  • Interacts 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 to.
  • Interface with GCTO partners on clinical trial execution.
  • Escalates site performance issues to CRM and Clinical Research Director CRD.
People and Resource Management:
  • Manage CRA - career development, performance reviews, etc., 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.
  • Provides training, support and mentoring to the CRA to ensure continuous development.
  • Ensures CRA compliance to corporate policies, procedures and quality standards
  • 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)
Experience Requirements:
  • Minimum of 5 years experience within Clinical Research
  • Minimum of 3 years' experience as CRA monitoring clinical trials
  • Line management experience preferred or at the minimum team leader experience
  • Bachelor's degree in science or advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or biology
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