Senior Study Start Up Lead

Essential Functions: 

• Updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures.  

• Manages both the technical and operational aspects of site identification, site feasibility and site activation for assigned projects, site contracts, and project teams. 

• Maintains and analyzes study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement.  

• Executes all start-up activities prior to site activation on assigned studies, according to standards and aligned with study/project requirements and timelines.  

• Prepares country level Informed Consent Form (ICF) and obtains ethics committees' and local regulatory authorities' approval. Prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country. 

• Partners with other study team members to provide guidance on regulatory/ethics requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions/activations.  

• Supports drug label preparation and approval (as local label representative) for studies in collaboration with local Regulatory /Quality department, as required.  

• In collaboration with Clinical Site Manager, identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required.  

• Responsible for study budget and contracts negotiation in collaboration with Legal team, as required and ensures compliance with Fair Market Value (FMV) in the country. 

• Other duties as assigned. 

Necessary Skills and Abilities: 

• Excellent verbal and written communication skills 

• Must be able to prioritize and manage multiple projects and show attention to detail. 

• Comprehensive knowledge and understanding of ICH-GCP  

• Working knowledge and experience in Microsoft Office (e.g., Word, Excel, Project) 

• Experience with working in eTMF and CTMS within the framework of the study start up responsibilities.   

Educational Requirements: 

• Bachelor’s degree required, preferably in life sciences, or related discipline. 

• Persons without a formal degree who have comparable depth and breadth of training and experience and who meet job-specific criteria are eligible for consideration. 

Experience Requirements: