Professional Overview
Experienced Clinical Data Management professional with proven expertise in leading end-to-end delivery of data management services across single and multi-service clinical projects. Adept at ensuring high-quality deliverables are completed on time, within budget, and in full compliance with GCP, regulatory requirements, and SOPs.
Key Responsibilities & Expertise
Client & Stakeholder Management
- Act as the primary point of contact for clients on all data management deliverables
- Build and maintain strong, long-term customer relationships
- Collaborate with client data managers, stakeholders, and internal teams to ensure seamless project execution
- Lead discussions on timelines, resourcing, deliverables, and process improvements
- Manage escalations effectively, ensuring timely resolution of issues
Project & Service Delivery
- Lead full data management lifecycle from study start-up to close-out
- Provide technical and operational leadership across DM projects
- Ensure milestones, deliverables, and timelines are consistently met
- Serve as escalation point for complex or unresolved data issues
- Coordinate closely with Data Operations teams, functional leads, and project managers
- Oversee development, review, and approval of Data Management Plans (DMPs)
- Implement proactive quality management strategies and drive continuous improvement
Quality & Compliance
- Ensure all processes are aligned with Good Clinical Practice (GCP) and regulatory guidelines
- Monitor quality metrics and identify root causes of issues
- Lead corrective and preventive actions (CAPA) where needed
- Maintain compliance with SOPs, policies, and internal systems
Financial & Operational Oversight
- Manage project budgets and Scope of Work (SOW) deliverables
- Review financial performance and contribute to project forecasting
- Identify and manage out-of-scope activities and change orders
- Support revenue tracking, invoicing, and financial reporting
- Contribute to RFP responses, pricing strategies, and bid defense meetings
Leadership & Continuous Improvement
- Provide leadership and mentorship to data management teams
- Promote efficient workflows and high-quality standards
- Contribute to process optimization and implementation of new technologies
- Participate in global and local best practice initiatives
Core Competencies
- Clinical Data Management Lifecycle (Phase I–III, especially Phase III)
- Data Team Leadership (DTL)
- Project Management & Delivery
- Stakeholder & Client Management
- Database & Data Quality Oversight
- SAE & External Vendor Reconciliation
- GCP & Regulatory Compliance
- Cross-functional Team Leadership
- Financial & Resource Management
- Process Improvement & Innovation
Qualifications
- Bachelor’s degree in Health, Clinical, Biological, Mathematical Sciences or related field
- ≥3 years Clinical Data Management experience
- ≥1 year experience as Project Lead / Data Team Lead
- Proven delivery of at least one Phase III clinical study
- Strong knowledge of Medical terminology, pharmacology, anatomy, physiology, Data management systems and processes, Regulatory requirements and GCP
Professional Strengths
- Excellent communication, interpersonal, and customer engagement skills
- Strong analytical and problem-solving ability
- Highly organized with strong attention to detail
- Ability to work independently with minimal supervision
- Proven ability to build and maintain collaborative relationships
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