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Form of workICON 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:
- Bachelor's degree
- Based in Spain, will consider candidates from UK and France
- At least 5 years of experience in effectively managing global clinical studies (prior oncology clinical trial experience is preferred)
- Extensive phase I experience is essential
- Oncology experience 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.
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
