Project planning and execution
- Develop and manage project timelines and budgets.
- Create and refine study documents, including the protocol and other plans.
- Support the selection of investigational sites and manage vendor selection and relationships.
- Plan and conduct investigator meetings.
Team and stakeholder management
- Serve as the primary point of contact for clients, sponsors, and internal teams.
- Lead and motivate cross-functional project teams, including Clinical Research Associates (CRAs), data managers, and others.
- Communicate project status, risks, and issues to senior management and stakeholders.
Risk and compliance management
- Identify and mitigate potential risks and challenges to keep the trial on track.
- Resolve issues, such as protocol deviations, and manage quality and compliance with regulatory standards (like GCP).
- Oversee the implementation of any protocol amendments.
- Ensure all trial communication and documentation is filed correctly, such as in the Trial Master File.
Data and quality assurance
- Oversee data collection and management processes to ensure accuracy and integrity.
- Lead the ongoing review of study data for quality and consistency.
- Participate in the preparation of Clinical Study Reports (CSRs).