Senior Clinical Data Manager (External Data) | Full-Time | Bangalore, India
Experience Required: 8+ years
Job Description:
We are seeking an experienced Senior Clinical Data Manager (External Data) to lead end-to-end data management activities for global clinical trials. This role is responsible for overseeing external vendor data integration, ensuring high-quality data delivery, and managing clinical data processes from study start-up through database lock.
The ideal candidate will bring strong leadership experience, deep expertise in clinical data management, and the ability to collaborate with sponsors and cross-functional teams to deliver compliant, high-quality clinical data outcomes.
Key Responsibilities:
Clinical Data Management Leadership
Lead and manage data management (DM) activities across the full clinical trial lifecycle, from study start-up to database lock.
Act as Subject Matter Expert (SME) for DM processes in sponsor meetings and client engagements.
Provide leadership, mentorship, and training to junior data management team members.
Ensure all deliverables meet quality standards, timelines, and budget requirements.
External Data & Vendor Management
Develop and maintain Vendor Data Plans (VDP) for external data transfers, ensuring compliance with study protocols.
Oversee external vendor data integration, ensuring data accuracy, format consistency, and correct mapping.
Review vendor Statements of Work (SOW) and ensure alignment with protocol requirements.
Coordinate data receipt, reconciliation, and validation from external sources such as laboratories and third-party vendors.
Project Management & Delivery
Plan, manage, and track study timelines, deliverables, and milestones in collaboration with project managers and cross-functional teams.
Lead internal project meetings and coordinate with EDC design, biostatistics, SAS programming, and pharmacokinetics teams.
Identify project risks and implement mitigation strategies to ensure timely database lock.
Manage scope changes, budget tracking, and sponsor communications.
Quality & Compliance
Ensure compliance with ICH-GCP guidelines, SOPs, and regulatory standards.
Maintain audit readiness and support internal and external audits and inspections.
Perform data reconciliation across clinical, safety, and laboratory datasets.
Contribute to the development and improvement of SOPs and data management processes.
Client & Stakeholder Management
Build and maintain strong relationships with sponsors and stakeholders.
Act as the primary point of contact for data management-related discussions.
Support bid defense meetings and contribute to new business opportunities.
Monitor client satisfaction and implement continuous improvement initiatives.
Innovation & Process Improvement
Stay updated with emerging clinical data technologies and industry best practices.
Drive process improvements and implement efficient data management workflows.
Promote knowledge sharing and best practices within the data management team.
Qualifications & Experience:
Bachelor’s degree in Life Sciences, Health Sciences, Information Technology, or related field (Master’s preferred).
Minimum 8+ years of clinical data management experience, including:
2+ years in direct sponsor management
2+ years in team leadership or mentoring roles
Strong expertise in external data handling, vendor management, and data reconciliation.
Experience with Electronic Data Capture (EDC) systems and clinical data platforms.
In-depth understanding of clinical trial processes, biometrics, and regulatory requirements.
Proven experience in project management, budgeting, and scope management.
Excellent communication, leadership, and stakeholder management skills.
Ability to manage multiple complex projects in a fast-paced environment.
Location: Bangalore, India
Why Join Us:
Lead global clinical data management projects with high impact on drug development.
Collaborate with cross-functional teams across biometrics, clinical operations, and regulatory functions.
Gain exposure to advanced clinical data systems and emerging technologies.
Access leadership development opportunities and career growth in a global CRO environment.
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