Associate Director

MSD Malaysia; Petaling Jaya; On-site; MYR 280,000 - 420,000; Full time

Job summary

MSD Malaysia is seeking an Associate Director (CRAM) to lead a team of 6–14 CRAs and drive high-quality monitoring of clinical trials in Malaysia. The role ensures adherence to local regulations, SOPs and ICH-GCP, while mentoring CRAs and optimizing resource allocation.

Reporting to the CRD or Head of Site Management and Monitoring, you will collaborate with country PLMs and HQ capacity planning to align monitoring functions and develop country capabilities.

Qualifications

• Bachelor’s degree in science or higher with emphasis in science/biology.
• 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.
• Fluent in local language and business English.

Responsibilities

• Work allocation, staff development and performance appraisal.
• Provides input for capacity planning and forecasting CRA capacity and needs.
• Coordinate with CRAs, PLMs and other functions to ensure process consistency across the country.
• Interface with sites to resolve operational issues and meet commitments.
• Attend local Investigator Meetings if requested.
• Interface with GCTO partners on clinical trial execution.
• Escalates site performance issues to CRM and Clinical Research Director.

Skills

People leadership

Clinical Research Management

Project management

Clinical Trials Monitoring

Stakeholder management

Team leadership

Decision making

GCP/ICH-GCP knowledge

Resource allocation

Education

Bachelor's degree in science or higher

Tools

CTMS

Clinical Trial Documentation

Job description

Job Description

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

• 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

CORE Competency Expectations

• 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

Behavioural Competency Expectations

• 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

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

Required Skills

• Adaptability, Biological Sciences, Clinical Research, Clinical Research Management, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Clinical Trials Operations, Cross-Cultural Awareness, Decision Making, Ethical Standards, Good Clinical Practice (GCP), Immunochemistry, Oncology Trials, People Leadership, People Management, Project Management, Resource Allocation, Resource Planning, Stakeholder Management

Preferred Skills

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