Manager, Clinical Data Management
Location: Bangalore, India
Employment Type: Full Time
Job Overview
The Manager, Clinical Data Management is responsible for leading and supporting a team of Clinical Data Management professionals to ensure the efficient delivery of high-quality clinical databases and data management services that meet customer, regulatory, and project requirements. The role combines leadership, operational oversight, client engagement, resource planning, financial management, and quality assurance within a global clinical research environment.
Key Responsibilities
Clinical Data Management Leadership
Provide expert review and guidance for Clinical Data Management deliverables including:
CRF/eCRF Design
Database Design and Setup
Validation Specifications and Programming
Data Management Plans (DMPs)
Clinical Database Deliverables
Ensure all deliverables meet quality, regulatory, and client expectations.
Provide technical expertise and solutions to internal teams and clients.
Support problem-solving and process optimization initiatives.
Contribute operational input to proposals, budgets, and scope of work discussions.
Participate in proposal presentations and bid defense meetings.
People Management & Team Development
Lead and manage a team of Clinical Data Management professionals.
Conduct regular one-on-one meetings with direct reports.
Review:
Project status and timelines
Resource utilization
Training completion
Career development objectives
Project risks and mitigation plans
Administrative and compliance requirements
Identify skill gaps and training needs.
Mentor and coach team members to strengthen:
Data Management expertise
System knowledge
Drug development understanding
Leadership capabilities
Drive employee engagement and retention initiatives.
Resource & Capacity Planning
Collaborate with project leads to manage:
Resource allocation
Workforce planning
Project scheduling
Technology requirements
Peak workload management
Develop action plans to address staffing and project delivery challenges.
Ensure adequate project coverage and business continuity.
Project & Operational Management
Oversee delivery of multiple Clinical Data Management projects.
Monitor project timelines, milestones, and deliverables.
Ensure teams operate in compliance with:
SOPs
Work Instructions
Project Scope of Work
Regulatory Requirements
Support issue escalation and resolution activities.
Drive operational efficiency and productivity improvements.
Client & Business Support
Support:
Request for Information (RFI)
Request for Proposal (RFP)
Budget Development
Scope Assessments
Participate in:
Kick-Off Meetings (KOMs)
Bid Defense Meetings
Client Discussions
Build and maintain strong relationships with clients and stakeholders.
Ensure customer satisfaction and high-quality service delivery.
Financial Oversight
Support project financial management activities including:
Estimate at Completion (EAC)
Forecasting
Burn Rate Monitoring
Out-of-Scope (OOS) Identification
Monitor project performance against financial targets.
Drive short-term and long-term business results.
Support profitability and operational efficiency goals.
Quality, Compliance & Inspection Readiness
Ensure teams are audit and inspection ready.
Participate in and support:
Internal Audits
External Audits
Regulatory Inspections
Ensure compliance with:
ICH-GCP Guidelines
Regulatory Requirements
Internal SOPs
Client Standards
Promote quality culture and continuous improvement.
Leadership Communication
Communicate organizational priorities and business updates effectively.
Escalate risks, opportunities, and issues to senior leadership when required.
Foster collaboration across cross-functional and global teams.
Demonstrate sound judgment and effective decision-making.
Qualifications
Education
Bachelor's Degree in:
Life Sciences
Pharmacy
Biotechnology
Clinical Research
Health Sciences
Related Scientific Discipline
Master's Degree preferred.
Experience (Minimum Required)
14+ years of relevant Clinical Data Management experience.
Minimum 3+ years of people management or line management experience.
Advanced knowledge of:
Clinical Data Management Processes
EDC Systems
Clinical Database Design
Data Validation Processes
Drug Development Lifecycle
Proven experience in:
Team Leadership
Resource Planning
Client Management
Project Delivery
Financial Oversight
Strong understanding of:
Clinical Research Operations
Regulatory Requirements
Quality Standards
Clinical Trial Data Processes
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