Advancell

Responsibilities will include, but not limited to:

• Develop, manage, and track site and study budgets in collaboration with CROs and internal Finance partners. 
• Review, reconcile, and approve vendor and CRO invoices against contracts, milestones, and deliverables. 
• Support clinical operations contracting processes, including review of scopes of work, vendor agreements, and amendments. 
• Manage and review change orders, ensuring alignment with scope, timelines, and budget. 
• Generate and maintain purchase orders (POs) in accordance with company processes and study budgets. 
• Support vendor selection, onboarding, and ongoing performance management to ensure adherence to KPIs and contractual commitments. 
• Support oversight of CROs to ensure clinical trials are executed according to timelines, quality standards, and contractual obligations. 
• Conduct and/or oversee quality control of the Trial Master File (TMF) to maintain accuracy and continuous inspection readiness. Monitor TMF completion metrics to ensure timely and comprehensive document completeness.
• Collaborate closely with cross-functional teams including Finance, Legal, CMC, Pre-clinical to ensure seamless execution of clinical programs. 
• Proactively identify risks in study execution and financial management, and implement mitigation strategies.
• Support onboarding procedure and training on internal processes for new team members.

• Adhere to the Company's quality management system processes and policies. 
• Comply with applicable regulatory requirements, policies, and procedures related to financial reporting transparency, Good Clinical Practice (GCP), and Good Documentation Practice (GDP).
• Other tasks as requested by the VP Clinical Development and Operations. 

• Strong knowledge of clinical trial conduct, ICH-GCP guidelines, regulatory requirements, and the Sunshine Act.
• Meticulous attention to detail to ensure accuracy in documentation and financial tracking. 
• Demonstrated ability to manage budgets, forecasting, and financial reconciliation. 
• Flexibility to collaborate across different time zones
• Experience with TMF processes and inspection readiness standards. 
• Ability to work to timelines and perform effectively in high-pressure environments. 
• Strong organizational, analytical, and problem-solving skills. 

• Proven track record in clinical operations delivery within a sponsor or CRO environment. 
• Demonstrated expertise in vendor management, CRO oversight, and contract management. 
• Experience with budgeting tools, CTMS, and eTMF systems. 
• Strong communication and collaboration skills across cross-functional teams. 
• Minimum 6-10 years' experience in clinical operations (depending on level).
• Bachelor's degree in life sciences required; advanced degree (MSc or higher) preferred.