Country Clinical Research Lead

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.

You will be joining one of our clients, a biotechnology company that is at the epicenter of innovative drug development. This program is for you if you are looking for an innovative environment where you can develop and grow while making a valued contribution to improving people’s lives.

You will be joining as the Country Project Manager and will be responsible for the operational delivery of strategic clinical studies assigned to Germany, to support the client\’s pipeline, in accordance with ICH/GCP, SOPs, local operating guidelines and local requirements, as applicable.

What you will be doing:

1. Work locally, supporting Clinical Operations to ensure corporate/country goals for recruitment and completion of key R&D sponsor deliverables are met.
2. Act as the central point of contact for feasibilities in the country/ies, for both in-house and outsourced clinical studies when feasibilities are requested or deferred to country/ies by Global Teams.
3. Lead the planning and implementation of cross-functional project(s).
4. Facilitate the definition of project scope, goals and deliverables.
5. Define project tasks and resource requirements.
6. Develop full-scale cross-functional project plans.
7. Manage project budget.
8. Plan and schedule project timelines.
9. Track project deliverables using appropriate tools.
10. Travel (approximately 20-30%) domestic and/or international.

You are:

• At least 5 years of clinical research experience as Lead CRA or Project Manager.
• Bachelor\’s or higher University degree in life sciences, nursing or medical background preferred.
• Demonstrated knowledge of clinical trial methodology and drug development process, related to monitoring clinical trials, GCP, SOP and country-specific regulatory requirements.
• Demonstrated understanding of applicable medical/therapeutic area knowledge and medical terminology.
• Effective oral, written and presentation skills, with the ability to communicate effectively with varied audiences in both English and German.
• Ability to travel (approximately 20-30%).

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