Plan, coordinate, and execute clinical trial activities across regions in compliance with ICH-GCP, ensuring timely and high-quality delivery.
Maintain and oversee trial documentation (e.g., ISF, TMF, submissions), ensuring completeness, accuracy, timeliness and audit readiness.
Collaborate with global and regional stakeholders, vendors, and trial teams to ensure seamless trial conduct and communication.
Manage and maintain clinical trial systems, databases, and tracking tools ensuring data accuracy.
Prepare and distribute project plans, status updates, reports, and presentation materials.
Monitor trial progress, budgets, and system data, identifying risks and implementing corrective actions as needed.
Coordinate documentation workflows, regulatory submissions, and communication with authorities and regional teams.
Support reporting, trial close-out activities, and preparation of key deliverables (e.g., CTR appendices).
Coordinate logistics for trial meetings, materials, and supplies.
Contribute to quality oversight, inspection readiness, and best practices in clinical trial conduct.
Act as a key point of contact for trial-related systems, documentation, and operational queries.

University degree qualified and/or comparable professional education
At least 5 years’ experience in clinical trial operations or project coordination
Exceptional communication and stakeholder management skills
Strong knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Excellent organizational and problem-solving skills with ability to work independently, prioritize tasks, and manage projects in a complex international environment
Detail-oriented with strong commitment to quality and compliance
Proficiency in MS Office and clinical trial systems/tools
Fluent in written and spoken English

Senior Clinical Project Support Specialist – Sponsor Dedicated

Key skills