Principal Clinical Data Project Manager

General Summary

Provides a full spectrum of support for clinical data project activities. Responsible for the successful planning, implementation, and execution of contracted services. Manages cross-functional teams and client expectations to achieve client satisfaction.

Primary Responsibilities

• Acts as liaison with client and manages client contractual, organization, and relationship needs/expectations. Ensures clear client communication, process documentation, and compliance with Good Clinical Practices (GCP) and company policies and procedures.
•  Coordinates with functional leads and managers to optimize performance and utilization of project team members.
• Achieves project quality by identifying quality risks and issues, responding to issues raised by project team members, and planning/implementing appropriate corrective and preventative action plans.
• Manages scope, schedule, and quality requirements of assigned clinical data project.
• Fosters strong client relationships at the project level to promote client retention and boost prospective business opportunities.
• Ensures timely completion of all clinical data project status reporting.

Other Responsibilities

• Takes a lead role in identifying issues and risks related to clinical data project activities. Leads the presentation of project risk reviews and is accountable for action item follow-up.
• Oversees daily activities of the project team and provides direction and
• Liaises with clinical data functional leads to provide data to create project performance metrics and initiate performance-measure improvements as needed.
• Manages resources and resource projections to ensure project teams are consistent with client needs, expectations,
• Provides leadership, training, guidance, and support to other clinical data staff.
• Supports business development activities by providing project information and intelligence on potential prospective business opportunities.
• Participates in audits and inspections and responds to audit findings.
• Acts as Subject Matter Expert (SME) for various technologies or processes.
• In-depth knowledge of clinical trial life cycle
• In-depth knowledge of regulatory compliance requirements
• In-depth knowledge of clinical data project processes and each function as it relates to clinical data
• Excellent written and oral communication skills
• Excellent attention to detail
• Ability to solve complex problems
• Advanced ability to effectively manage multiple tasks and projects
•  Ability to lead and coordinate small teams