Associate Manager - Clinical Data Management

vueverse. · India

Associate Manager – Clinical Data Management

Position Summary

We are seeking an experienced Associate Manager – Clinical Data Management to support and oversee end-to-end clinical data management activities for global clinical trials. Reporting to the Clinical Data Management (CDM) Lead, this role is responsible for ensuring the delivery of high-quality, accurate, and timely clinical data from study start-up through database lock and study close-out.

The ideal candidate will have extensive experience in clinical data management within a GCP-regulated environment and possess strong knowledge of electronic data capture systems, external data reconciliation, data review, and regulatory compliance. This position requires excellent organizational, communication, and leadership skills to collaborate effectively with cross-functional teams, CROs, and external vendors.

Key Responsibilities

Clinical Data Management

• Support the complete clinical data management lifecycle from study start-up through database lock and study close-out.
• Perform clinical data review, validation, and query management to ensure high-quality study data.
• Collaborate with study teams, CROs, and external vendors to resolve data discrepancies and ensure timely issue resolution.
• Participate in interim and final database lock activities.
• Ensure adherence to Clinical Data Management Standard Operating Procedures (SOPs) and applicable regulatory requirements.

Data Review & Reconciliation

• Perform comprehensive review of clinical trial data for accuracy, completeness, and consistency.
• Review eCOA and external vendor data according to Data Review Plans.
• Conduct reconciliation of external data sources with Electronic Data Capture (EDC) data.
• Perform Serious Adverse Event (SAE) reconciliation with safety databases.
• Monitor study metrics, identify risks, and escalate issues to the CDM Lead when necessary.
• Support data cleaning activities and ensure timely query resolution.

Data Collection Systems

• Support the setup, testing, validation, and maintenance of clinical data collection systems, including:
• Electronic Data Capture (EDC)
• Interactive Response Technology (IRT)
• Electronic Clinical Outcome Assessment (eCOA)
• Electronic Patient Reported Outcomes (ePRO)
• Assist in developing and maintaining study documentation, including:
• eCRF Completion Guidelines
• Data Validation Plans
• Data Integration Specifications
• Data Transfer Specifications
• Database Lock Plans
• Coding Guidelines
• External Data Reconciliation Plans

Documentation & Compliance

• Maintain study documentation within the electronic Trial Master File (eTMF).
• Perform periodic quality reviews of study documentation.
• Support inspection readiness and participate in internal and regulatory audits.
• Maintain accurate documentation of study activities, meeting minutes, and project deliverables.
• Ensure compliance with GCP, ICH, FDA regulations, corporate policies, and departmental procedures.

Vendor & CRO Management

• Collaborate with Contract Research Organizations (CROs) and external vendors to ensure successful execution of study deliverables.
• Monitor vendor performance and quality of deliverables.
• Coordinate issue resolution related to external data.
• Ensure effective communication between sponsors, CROs, and vendors throughout the study lifecycle.

Leadership & Collaboration

• Coordinate and oversee the work of Data Coordinators.
• Mentor junior team members and provide guidance on clinical data management best practices.
• Support cross-functional teams, including Clinical Operations, Biostatistics, Medical Monitoring, Safety, and Regulatory Affairs.
• Participate in departmental initiatives focused on process improvement and operational excellence.

Required Qualifications

• Associate's or Bachelor's Degree in Life Sciences, Pharmacy, Biotechnology, Nursing, Computer Science, or a related discipline preferred.
• Minimum 8 years of relevant Clinical Data Management experience , preferably within pharmaceutical, biotechnology, or CRO environments.
• Strong understanding of clinical trial processes and regulatory requirements.
• Experience working in GCP-compliant clinical research environments.

Required Technical Skills

• Clinical Data Management
• Electronic Data Capture (EDC)
• Interactive Response Technology (IRT)
• eCOA
• ePRO
• eCRF Design & Review
• Query Management
• Database Lock Activities
• External Data Reconciliation
• SAE Reconciliation
• Data Cleaning
• eTMF
• Data Validation
• Clinical Trial Documentation
• FDA Regulations
• ICH-GCP Guidelines
• Microsoft Office Suite

Preferred Skills

• Experience managing multiple clinical studies simultaneously.
• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder management abilities.
• Ability to work effectively in cross-functional and global teams.
• Strong organizational and time management skills.
• Quick learner with the ability to adapt to new technologies and processes.

Behavioral Competencies

• Strong attention to detail.
• Excellent interpersonal and collaboration skills.
• Effective project coordination abilities.
• Ability to prioritize multiple competing tasks.
• Comfortable working in a dynamic and fast-paced environment.
• Demonstrates accountability, ownership, and a quality-focused mindset.

Job Complexity

• Supports low to medium complexity clinical studies.
• May require occasional domestic and international travel to support project meetings, strategic partners, or clinical study activities.