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 efficient delivery of high-quality databases and data management solutions that meet customer and regulatory requirements. The role combines people leadership, project oversight, operational excellence, client interaction, financial awareness, and strategic planning within a global clinical research environment.
Key Responsibilities
Clinical Data Management Leadership
Provide expert guidance and oversight for all Clinical Data Management deliverables.
Review and support development of:
CRFs and eCRFs
Database Design and Setup
Edit Check Specifications
Validation Programming
Data Management Plans (DMPs)
Database Deliverables
Ensure compliance with SOPs, work instructions, project requirements, and regulatory standards.
Serve as a subject matter expert for Data Management processes and systems.
Provide technical solutions to internal and external stakeholders.
People Management & Team Development
Lead and manage a team of Clinical Data Management professionals.
Conduct regular one-on-one meetings with direct reports.
Monitor:
Project status
Timelines and deliverables
Resource utilization
Training completion
Career development goals
Risk and mitigation plans
Identify training needs and implement development plans.
Mentor team members to enhance:
Data Management expertise
System knowledge
Drug development understanding
Drive employee engagement initiatives and team performance.
Project & Resource Management
Collaborate with project leads on:
Resource planning
Staffing requirements
Workload forecasting
Technology needs
Peak workload management
Develop action plans to address project and staffing challenges.
Ensure effective allocation of resources across projects.
Provide support during project escalations and risk management activities.
Client & Business Support
Participate in:
Bid Defenses
Kick-Off Meetings (KOMs)
Client Meetings
Proposal Development Activities
Support:
Request for Information (RFI)
Request for Proposal (RFP)
Budget Development
Scope of Work Reviews
Build strong relationships with clients and internal stakeholders.
Ensure delivery of customer-focused solutions.
Financial & Operational Management
Monitor and manage project financial performance.
Understand and support:
Estimate at Completion (EAC)
Forecasting
Burn Rate Monitoring
Out-of-Scope (OOS) Identification
Drive business and financial performance objectives.
Ensure efficient operational delivery and resource utilization.
Quality, Compliance & Inspection Readiness
Support internal and external audits and inspections.
Ensure teams are trained and inspection-ready.
Maintain compliance with:
Regulatory Requirements
Internal SOPs
Client Standards
Good Clinical Practice (GCP)
Drive quality improvement initiatives and process standardization.
Leadership & Communication
Effectively communicate business priorities and organizational updates.
Escalate risks, challenges, and opportunities appropriately.
Demonstrate sound judgment and decision-making.
Foster collaboration across cross-functional and global teams.
Lead through influence within a matrix organization.
Qualifications
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 Clinical Data Management experience.
Minimum 3+ years of people management or line management experience.
Strong understanding of:
Clinical Data Management Processes
Clinical Database Design
Data Validation
Drug Development Lifecycle
Clinical Trial Conduct
Experience managing global Clinical Data Management teams.
Proven leadership and team development capabilities.
Strong project planning and resource management experience.
Experience supporting client-facing activities and business development initiatives.
Ability to manage multiple projects and competing priorities.
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