Study Start-Up Specialist

• Execute end-to-end start-up activities for assigned studies (country/region level), including feasibility, site identification, site initiation support, and start-up progress reporting, ensuring timelines, scope, and compliance with ICH/GCP, SOPs, protocols, and regulatory requirements
• Collect, review, approve, track, and quality-check all regulatory and investigator documents
• prepare and manage IEC/IRB submissions, amendments, regulatory fees, and collaborate with Regulatory on Health Authority/Competent Authority notifications
• Lead local adaptation and documentation of Informed Consent Forms
• ensure contracts are fully executed, regulatory approvals are granted, IP release is authorized, and all conditions for site activation are fulfilled
• Maintain complete, accurate, and timely start-up documentation in CTMS, TMF, SMF, and central repositories
• ensure proper submission of materials to TMF
• support SSU Lead/PM with project set-up, Greenlight activities, and site activation processes
• Support audits and inspections
• provide feedback on site performance
• participate in continuous improvement initiatives and cross-functional collaboration to enhance clinical operations

• Bachelor’s degree preferred
• minimum 1–3 years of relevant clinical research experience
• Good understanding of ICH/GCP, local regulatory requirements, SOPs, and corporate standards
• Experience with investigator start-up documents and investigative sites is preferred
• Strong communication, organizational, and cross-functional teamwork skills
• Ability to manage multiple priorities in a fast-paced environment
• strong computer skills

Experience with investigator start-up documents and investigative sites is preferred

• competitive compensation package
• comprehensive benefits
• opportunity for personal and professional growth in a rewarding environment