Leading global, cross-functional observational study teams and owning delivery of contracted scope, timelines, and quality
Developing study documentation, including project management plans
Ensuring consistent use of study tools, training materials, and compliance with SOPs, policies, and procedures
Monitoring study progress and financial performance; supporting forecasting and change control as needed
Lead project vendor management related activities and communications per project requirements
Anticipating operational and quality risks, responding to issues raised by the project team and planning/implementing appropriate corrective or preventative actions
Generating project
or program-level metrics and reports for senior management
Capturing lessons learned and contributing to continuous improvement and best practices
Requirements
Bachelor's degree in life sciences or related field
Minimum 4-6 years of experience in project management and/or clinical operations within pharma, CRO, or RWE environment (or equivalent combination of education, training, and experience)
Demonstrated experience leading observational or real-world evidence studies
Strong understanding of RWE study designs and clinical research conduct and skill in applying applicable clinical research regulatory requirements
Experience with primary and secondary data study designs
Therapeutic area expertise desired (oncology, virology, inflammation)