Clinical Operations Lead Early Phase Oncology

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Pharmacovigilance. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities:

• Oversee CRO clinical teams to ensure efficient study start-up, including feasibility assessments, site selection, and timely completion of regulatory and ethics documentation.
• Ensure all site set-up and EDC-related clinical activities are completed on time and in compliance with defined timelines.
• Support and contribute to CRA training, as well as the preparation and delivery of investigator and monitoring meetings in collaboration with cross-functional teams.
• Assist the study lead and project team in defining study timelines, milestones, and deliverables, ensuring high-quality and timely execution.
• Prepare, review, and approve key clinical oversight and study documents (e.g. monitoring plans, study manuals, KPIs/KRIs).
• Monitor site performance and risk indicators, review monitoring reports, and ensure appropriate and timely follow-up of findings.
• Coordinate and manage CRO relationships, including oversight of CRAs/CTLs and participation in RFP and bid defense activities.
• Perform co-monitoring activities, contribute to study data reviews, and proactively identify and resolve operational issues.
• Ensure timely and accurate data collection, query resolution, and effective coordination of study samples and assessments across stakeholders.
• Conduct regular TMF quality reviews and support audit and inspection readiness and follow-up activities.
• Act as a company ambassador at investigator sites, building strong relationships while ensuring compliance with GCP, ICH guidelines, and internal SOPs.