O pozici
The IQVIA Clinical Functional Service Partnerships (Clinical FSP) department is providing highly skilled professionals to our client’s project team to set-up and execute clinical trials.
Senior Clinical Project Support Specialist will provide operational support and coordination for global clinical trials, ensuring efficient trial execution from planning through close-out. Responsible for managing trial-related documentation, systems, communication, and logistics in compliance with SOPs, ICH-GCP, and regulatory requirements, while meeting quality and timeline objectives.
Co budeš dělat
- 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.
Koho hledáme
- 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
Benefity
- For candidates based in Austria, we offer a market-competitive gross annual salary starting at €58,500, depending on your qualifications and relevant professional experience.
