Description
Responsibilities:- Develop and manage clinical project plans against established goals, milestones, timelines and budget.
- Responsible for management of clinical meetings including but not limited to preparing agendas, facilitation of meetings, and issuing meeting minutes.
- Closely monitors and tracks project schedules toward milestones and issues status reports, including assessment of critical path activities.
- Facilitates communication between Clinical and Project Management departments.
- Anticipates, identifies, and promptly resolves discrepancies in project priorities, plans, and activities in a timely fashion.
- Develops and tracks project budgets, identifies variances, anticipates scope changes, and communicates changes and issues that may impact the current project budget to Clinical management, Project Management, Finance, and other appropriate key stakeholders.
- Facilitate resolution of issues inter-department and across functional lines pertaining to project priorities and team dynamics.
- May lead clinical trial project execution to ensure that trial timelines, costs, and quality metrics are met.
- May manage the financial aspect of clinical trials to ensure accuracy and timeliness of service provider and site payments.
- May forecast and oversee clinical supplies, e.g. study drug.
- Manage study milestones to ensure accurate tracking and reporting of study metrics.
- Create and manage clinical trial budgets in collaboration with Head of Clinical Operations.
- Provide study-specific direction and mentoring to CRAs and CTAs.
- Collaborate with Clinical Quality Assurance to maintain and manage quality standards in compliance with regulatory requirements/guidances and adherence to SOPs and ICH/GCPs; participate in ongoing process improvement initiatives.
- Participate in clinical operations initiatives and programs.
- Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.