Senior Clinical Data Manager

Latinum HR Solutions; Mumbai; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Latinum HR Solutions seeks a Senior Manager - Clinical Data Management to lead data management for global development programs. You will manage in-house and outsourced CDM activities, oversee CRO/vendor relationships, and ensure high-quality data deliverables and regulatory readiness.

The role requires 7+ years in Life Sciences with expertise in EDC, IRT, ePRO/eCOA, CDISC, and GxP compliance. Collaboration with Clinical Operations, Statistics, and cross-functional teams is essential for success.

Qualifications

• Lead clinical data management activities across in-house and outsourced studies.
• Provide CRO/vendor oversight across global development programs.
• Represent Data Management in cross-functional clinical teams.
• Lead data collection setup (EDC, IRT, ePRO, eCOA).
• Develop data cleaning, edit checks, data validation plans and data transfer specs.
• Lead data review, query management, and database lock activities.
• Support regulatory submission readiness and TMF archival/inspection readiness.
• Partner with stakeholders and CROs to mitigate risks and issues.
• Manage Data Management budgets, timelines, forecasting and metrics.
• Drive continuous improvement and adoption of technology in CDM.
• Ensure compliance with ICH-GCP and GxP.

Responsibilities

• Lead Clinical Data Management activities across in-house and outsourced clinical studies.
• Provide CRO and vendor oversight across global development programs.
• Represent Data Management within cross-functional clinical teams and ensure alignment on data-related deliverables.
• Lead clinical trial data collection setup, including EDC, IRT, ePRO and eCOA.
• Develop and oversee data cleaning plans, edit checks, data validation plans, data integration and transfer specifications.
• Lead data review, query management, and interim/final database lock activities.
• Support regulatory submission readiness and ensure TMF archival and inspection readiness.
• Partner with stakeholders and CROs to identify, mitigate, and resolve risks and escalated issues.
• Manage Data Management budgets, timelines, forecasting and performance metrics.
• Drive continuous improvement initiatives and adoption of technology within Clinical Data Management.
• Ensure compliance with ICH-GCP and applicable GxP requirements.

Skills

Clinical Data Management

CRO/vendor management

CDISC standards

EDC/IRT/ePRO

ICH-GCP/GxP

Stakeholder management

Data quality & delivery

Education

Bachelor’s/Master’s in Life Sciences/Pharmacy/Bio-Pharma

Clinical Research/Statistics

Tools

EDC systems

eCOA

Clinical Data Management tools

Job description

We are seeking an experienced Senior Manager - Clinical Data Management to lead and oversee clinical data management activities supporting global clinical development programs. The role involves managing in-house and outsourced data management activities, providing CRO and vendor oversight, ensuring data quality and timely delivery, and supporting regulatory submission readiness. The successful candidate will collaborate closely with Clinical Operations, Statistics, Statistical Programming, Therapeutic Area teams, CROs, and other cross-functional stakeholders to ensure high-quality clinical data management deliverables.

ROLE DETAILS

Location: PAN India

Experience: 7+ Years

Domain: Life Sciences / Bio-Pharma

Role: Senior Manager - Clinical Data Management

EDUCATION

Bachelor’s / Master’s degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, Biochemistry, Statistics, or a related field.

Key Responsibilities

• Lead Clinical Data Management activities across in-house and outsourced clinical studies.
• Provide CRO and vendor oversight across global development programs.
• Represent Data Management within cross-functional clinical teams and ensure alignment on data-related deliverables.
• Lead clinical trial data collection setup, including EDC, IRT, ePRO and eCOA.
• Develop and oversee data cleaning plans, edit checks, data validation plans, data integration and transfer specifications.
• Lead data review, query management, and interim/final database lock activities.
• Support regulatory submission readiness and ensure TMF archival and inspection readiness.
• Partner with stakeholders and CROs to identify, mitigate, and resolve risks and escalated issues.
• Manage Data Management budgets, timelines, forecasting and performance metrics.
• Drive continuous improvement initiatives and adoption of technology within Clinical Data Management.
• Ensure compliance with ICH-GCP and applicable GxP requirements.

Required Skills

• Strong experience in Clinical Data Management
• Hands-on experience with clinical trial data review and database lock
• Strong CRO / vendor management and oversight experience
• Knowledge of CDISC standards and clinical data management processes
• Experience with EDC and clinical data collection technologiesUnderstanding of ICH-GCP / GxP requirements
• Strong stakeholder management and cross-functional collaboration skills
• Excellent analytical, problem-solving and project management capabilities

Preferred Experience

Professionals with experience managing clinical data activities across global clinical development programs, working with CROs/third-party vendors, and collaborating with Clinical Operations, Biostatistics, Statistical Programming and other cross-functional teams are preferred.