Associate Manager - Clinical Data Management & Clinical Trial Data Operations

Why This Role Matters

Clinical trials generate large volumes of complex data that must be accurately collected, managed, and analyzed to support regulatory submissions and scientific decision-making. Clinical Data Management plays a critical role in ensuring that this data is reliable, consistent, and compliant with regulatory standards. The Associate Manager – Clinical Data Management supports the successful execution of clinical research projects by overseeing data management activities throughout the clinical trial lifecycle. This includes designing data collection systems, managing clinical databases, and ensuring that clinical trial data meets strict quality and regulatory requirements. In modern clinical research, data quality is essential for maintaining the integrity of study results and ensuring patient safety. Data management professionals ensure that clinical data is accurate, complete, and ready for statistical analysis and regulatory review.
Another important aspect of the role involves collaboration with cross-functional teams such as clinical operations, biostatistics, and external vendors. By coordinating data management activities across these groups, the Associate Manager helps ensure that clinical trial milestones are achieved efficiently. The role also involves implementing data standards, maintaining documentation, and supporting regulatory inspections or audits. Strong oversight of external vendors and contract research organizations is essential to ensure that all deliverables meet quality expectations and project timelines. For professionals experienced in clinical data management, this position provides an opportunity to lead data-related activities within global clinical trials while contributing to the development of high-quality healthcare products. Overall, the role supports the successful management of clinical trial data, enabling pharmaceutical and healthcare companies to generate reliable evidence for regulatory approvals and product development.

Job Description

The Associate Manager – Clinical Data Management is responsible for planning, coordinating, and overseeing data management activities related to clinical research projects. The role ensures that clinical trial data is collected, processed, and maintained in compliance with regulatory guidelines and organizational standards. Professionals in this role manage the design and implementation of data management tasks for clinical studies, including the development of electronic data capture systems and data management plans. They collaborate closely with clinical and biostatistics teams to ensure that study data meets the requirements for statistical analysis and regulatory submissions. The position also involves managing data collection systems such as Electronic Data Capture (EDC) platforms and integrating data from external systems including electronic patient-reported outcomes and other clinical data sources. In addition to technical responsibilities, the Associate Manager provides oversight of external vendors responsible for data management services. This includes evaluating vendor proposals, monitoring service delivery, and ensuring compliance with service-level agreements. The role also includes reviewing study documentation, organizing data quality review meetings, and ensuring that clinical datasets remain accurate and complete throughout the study lifecycle. Overall, the position combines leadership, data management expertise, and cross-functional collaboration to ensure the successful delivery of high-quality clinical trial data.

Key Features of the Role:

• Leadership role within clinical data management operations.
• Opportunity to manage end-to-end clinical trial data processes.
• Collaboration with clinical operations, biostatistics, and regulatory teams.
• Involvement in data quality management and regulatory compliance.
• Exposure to advanced clinical data systems and digital data collection tools.
• Opportunity to oversee external vendors and CRO partners.
• Participation in global clinical research projects.
• Career development in clinical data management and clinical research leadership.

Responsibilities

• Plan and manage data management activities for clinical research projects.
• Design and implement data management solutions for complex clinical studies.
• Ensure all data management activities comply with regulatory guidelines and quality standards.
• Coordinate with clinical and biostatistics teams to support clinical data analysis.
• Manage electronic data capture systems and other clinical data collection platforms.
• Author and review data management study documents including Data Management Plans and eCRF guidelines.
• Conduct data quality review meetings with cross-functional study teams.
• Monitor and ensure data accuracy, completeness, and consistency throughout clinical trials.
• Provide oversight to external vendors and contract research organizations responsible for data management deliverables.
• Evaluate proposals from external service providers and manage vendor relationships.
• Maintain clinical data standards and support the development of standardized data structures.
• Support regulatory inspections and audits related to clinical data management.
• Mentor junior team members and support their professional development.

Required Qualifications

• Strong understanding of clinical data management processes.
• Knowledge of clinical trial regulations and industry standards.
• Ability to manage complex projects and coordinate cross-functional teams.
• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder management abilities.

Educational Requirements

• Bachelor’s degree in Mathematics, Science, Pharmacy, Life Sciences, or a related field.

Experience and Skills

• Minimum of 8 years of clinical data management experience in the healthcare or pharmaceutical industry.
• Strong knowledge of clinical trial regulations including International Council for Harmonisation guidelines and Good Clinical Practice standards.
• Experience working with Clinical Data Management Systems (CDMS) and Electronic Data Capture platforms.
• Experience integrating data from multiple clinical data sources such as eCOA and external datasets.
• Strong project management and organizational skills.
• Experience managing vendor relationships and service delivery agreements.
• Ability to analyze clinical data metrics and generate reports for decision-making.
• Strong written and verbal communication skills.

Salary Insights

Associate Manager – Clinical Data Management roles in India typically offer salaries ranging from ₹18 LPA to ₹28 LPA, depending on experience, leadership responsibilities, and expertise in clinical data systems.

Company Overview

Kenvue is a global consumer health company known for its trusted healthcare brands and commitment to science-driven innovation. The organization develops and markets well-known healthcare and personal care products including Neutrogena, Aveeno, Tylenol, Listerine, Johnson's, and Band-Aid.
With a strong heritage in consumer healthcare and a focus on science-based innovation, the company operates globally and serves millions of consumers through its health and wellness products.

FAQs

• What does a Clinical Data Management Associate Manager do?
This role oversees the management of clinical trial data, ensuring data accuracy, quality, and compliance with regulatory standards.

• What systems are commonly used in clinical data management?
Professionals typically work with Electronic Data Capture systems and Clinical Data Management Systems.

• Is vendor management part of this role?
Yes, the role includes oversight of external vendors and CRO partners responsible for data management deliverables.

• What career growth opportunities exist?
Professionals may advance to roles such as Clinical Data Management Manager, Director of Data Management, or Head of Clinical Data Operations.

Application Tips

• Highlight experience in clinical data management systems and electronic data capture platforms.
• Emphasize knowledge of regulatory standards such as ICH guidelines and Good Clinical Practice.
• Showcase experience coordinating cross-functional clinical research teams.
• Demonstrate experience managing vendor relationships and project timelines.
• Include examples of clinical studies or data management projects you have supported.