Clinical Affairs, Senior (Study Operations) - Transplant Diagnostic

Clinical Affairs, Senior Study Operations

In this role, you will have the unique opportunity to lead clinical study operations to include clinical trial budgeting and study management activities. You will collaborate with cross-functional teams to support clinical planning and study execution. Additionally, you will analyze clinical affairs operations, identifying areas for improvement and implementing corrective measures.

Responsibilities :

• Manage overall clinical study budgets; negotiation and management of budgets with clinical sites, vendors, and CROs (e.g. CTAs, PO and invoicing)
• Support department leadership to determine resource allocation and financial forecasting for clinical studies.
• Interact with investigative sites, vendors, and other functional areas to ensure successful execution of clinical studies.
• Coordinate the planning of clinical studies to ensure that deliverables are completed on time and within budget.
• Develop and lead internal clinical project database.
• Update and / or generate internal Standard Operating Procedures (SOPs) to ensure GCP compliance.
• Support clinical study management activities to include, IRB / EC submission and approval activities and generating clinical site documentation in compliance to trial protocols.
• Participate on cross functional core project teams to ensure clinical deliverables are aligned with business objectives.

Qualifications :