Job Title: Senior Clinical Data Management Project Lead

The Senior Clinical Data Management Project Lead is responsible for the end-to-end delivery of data management services for single- and multi-study clinical projects. This role ensures high-quality data management deliverables are completed on time, within budget, and in compliance with GCP, regulatory requirements, SOPs, and contractual obligations. The role provides leadership, project management expertise, and subject matter expertise to Clinical Data Management (CDM) teams and may serve as a Data Team Lead (DTL), Program Lead, Project Manager, or SME.
 

Key Responsibilities

• Lead delivery of clinical data management services across studies or programs, ensuring quality, timelines, and budget adherence.

• Serve as primary customer contact for data management deliverables; maintain strong client relationships and manage escalations.

• Provide project management oversight, including planning, resource coordination, risk management, issue escalation, and change control.

• Develop, review, and approve Data Management Plans (DMPs); ensure services meet DMP and contract/SOW requirements.

• Oversee data quality, compliance, and audit readiness; implement proactive quality and risk management plans.

• Lead and mentor data management team members; support training and development of junior staff.

• Partner with functional managers to ensure appropriate resourcing and performance delivery.

• Manage financial aspects of projects, including budget tracking, change orders, and participation in project reviews.

• Drive process improvements, contribute to SOPs and best practices, and support implementation of new tools and technologies.

Required Skills & Experience

• Strong knowledge of clinical drug development and clinical data management processes.

• Demonstrated experience leading multiple clinical data management projects through the full lifecycle.

• Excellent project management, communication, and stakeholder management skills.

• Bachelor’s degree in health, clinical, biological, mathematical sciences, or related field (or equivalent experience).

• Ability to work independently and lead cross-functional teams.

• Occasional travel may be required.