CRA Manager

MSD Malaysia; Makati; On-site; PHP 1,500,000 - 3,000,000; Full time

Job summary

Merck & Co., Inc. in Makati seeks a Clinical Research Director to lead a team of 6-14 CRAs, ensuring strong study and site performance with strict adherence to regulatory standards. This country-level role requires mentoring, training, and effective resource management across local and HQ stakeholders.

The position emphasizes collaboration with country Partner Line Managers, ongoing process alignment, and capacity planning to optimize trials and resource use. Oncology trial experience is a plus.

Qualifications

• Experience leading clinical trial monitoring teams.
• Strong knowledge of ICH-GCP and local regulations.
• Ability to mentor and develop CRA talent.
• Cross-functional stakeholder coordination.

Responsibilities

• Oversee a team of 6-14 CRAs to ensure study and site performance.
• Provide coaching, training, and performance management.
• Plan capacity and resource allocation with HQ and country partners.
• Resolve operational issues and ensure protocol adherence across sites.

Skills

Clinical Research Management

People Leadership

GCP Compliance

Regulatory Compliance

Project Coordination

Job description

Job Description This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the Clinical Research Director, 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 e.g. Clinical Research Manager to ensure alignment and development of the country capabilities. The role will collaborate with country Partner Line Managers to ensure alignment across all monitoring functions. The person contributes to Headquarters 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.

Required Skills

• Adaptability
• Adaptability
• Clinical Research
• Clinical Research Management
• Clinical Trial Documentation
• Clinical Trial Management
• Clinical Trial Planning
• Clinical Trials Monitoring
• Clinical Trials Operations
• Continuous Development
• Cross-Cultural Awareness
• Decision Making
• Ethical Standards
• Global Coordination
• Good Clinical Practice (GCP)
• Liaison Work
• Oncology Trials
• Partner Relationship Management (PRM)
• People Leadership
• Performance Improvements
• Policy Compliance
• Procedure Adherence
• Process Alignment
• Process Standardization
• Regulatory Compliance
• {+ 7 more}

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 10/9/2026