Associate Director, Clinical Research Associate Manager

MSD

Mumbai

On-site

INR 3,500,000 - 6,500,000

Full time

3 days ago
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Benefits offered by this job

Visa sponsorship
Relocation assistance

Job summary

MSD is seeking an Associate Director, Clinical Research Associate Manager to lead a team of 6–14 CRAs across the country, ensuring high-quality monitoring in clinical trials with strict adherence to ICH GCP and SOPs.

You will develop talent, provide training and mentoring, and collaborate with CRM, PLMs, and HQ capacity planning to optimize resources.

Qualifications

  • Masters degree in science or related field with clinical research exposure.
  • Fluent in local language and business English proficiency.

Responsibilities

  • Plan and allocate CRA resources; monitor performance.
  • Develop and mentor CRA team; conduct performance reviews.
  • Coordinate with PLMs and CRM to align monitoring functions.
  • Ensure compliance with ICH GCP and company SOPs.

Skills

Clinical Research
Clinical Trial Management
Line Management
People Leadership
Oncology Trials
GCP Knowledge
Project Management
Stakeholder Collaboration

Education

Masters in Science
Masters in Pharmacology
Master’s in Pharmacy

Tools

CTMS
ICH GCP

Job description

Job Description

Associate Director, Clinical Research Associate Manager This role 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 e.g. CRM 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.
Qualification :

Masters in science, Master's in Pharmacology/.Pharmacy/ Clinical Research

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
Behavioral 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
Required Skills:
  • Adaptability
  • Adaptability
  • Career Planning
  • Clinical Research
  • Clinical Research Management
  • Clinical Trial Documentation
  • Clinical Trial Management
  • Clinical Trial Planning
  • Clinical Trials Monitoring
  • Clinical Trials Operations
  • Cross-Cultural Awareness
  • Decision Making
  • Ethical Standards
  • Global Coordination
  • Good Clinical Practice (GCP)
  • Liaison Work
  • Line Management
  • Oncology Trials
  • On Site Management
  • People Leadership
  • Performance Feedback
  • Policy Compliance
  • Procedure Adherence
  • Process Alignment
  • Process Standardization
  • {+ 7 more}

Employee Status: Regular

Relocation: VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements: Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date: 10/22/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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.

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