Project Manager

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing:

• Team leader and builder, who manages trial deliverables, timelines in assigned protocols to meet country commitments
• Responsible for quality and compliance in assigned protocols
• Works with minimal oversight from Clinical Operations Sr. Director or Director, in collaboration with Clinical Operations teams, and Clinical Research and Development functional teams
• Works with finance, legal, external vendors and clinical sites to ensure country deliverables are obtained for submissions, budgets, regulatory and local milestones
• Collaborates closely with Regulatory and Clinical Operations to align on country timelines
• Provides support and oversight to local vendors as applicable
• Oversight and coordination of local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements (in collaboration with TMF Operations team), insurance process management
• Enter and update country information in clinical, regulatory, safety and finance systems
• Ensure that clinical studies are conducted in accordance with approved protocols, ICH-GCP, EMEA, PMDA and other relevant regulations and guidelines

You are:

• Based in Spain
• At least 3 years Project Management experience in Phase 1 Oncology trials is essential
• In-depth knowledge of ICH-GCP, EMEA guidelines and other relevant regulations and guidelines
• Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety
• Ability to proactively develop risk management and mitigation plans in country and resolve issues locally
• Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills
• High sense of accountability and urgency in order to prioritize deliverables
• Strong communication skills and negotiation skills as well as excellent influencing and training/mentoring, both written and verbal
• Ability to focus on multiple deliverables and protocols simultaneously is essential
• Positive mindset, growth mindset, capable of working independently and being self-driven
• Able to directly influence Clinical Operations staff