Archiviertes Projekt - Clinical Study Lead

For one of our well-known medtech clients we are currently looking for a

Clinical Study Lead

- Start: As soon as possible
- Project Volume: max. 40 hours per week, remote
- Project Duration: 6month+

Tasks
- Author and review clinical study documentation in accordance with project and clinical study requirements, such as CPSP, IRB, CPSR, and Monitoring Plans, among other relevant documentation
- Manage and track clinical studies and budgets, ensuring timely completion within budget constraints. Escalate potential issues and set up internal and external communications for correction, troubleshooting, and prevention planning
- Advise project teams and pharmaceutical partners on clinical study requirements and provide regular status updates
- Establish and maintain assigned study master files containing appropriate documentation
- Ensure that study sites are prepared, equipment is in place, and training is provided in compliance with the clinical protocol. Provide training and necessary study documentation to clinical sites and CRAs, and review and approve monitoring reports
- Provide input from the Clinical Affairs function for studies during audits, such as BIMO, pharmaceutical partner audits, and FDA audits
- Obtain necessary ethical or notified body approvals for clinical study conduct in accordance with country requirements
- Maintain a valid GCP certification obtained within the last two years

Qualifications

- Exceptional communication skills, both verbal and written, are essential
- A keen attention to detail and excellent planning abilities are necessary
- Goal-oriented, with the capability to design and execute timelines based on study milestones, and to keep timelines/action plans updated and well-tracked
- Problem-solving oriented, proficient in defining problems, identifying root causes, and devising conclusions and mitigation plans
- Strong interpersonal and teamwork skills, with the ability to work effectively across cultures with diverse individuals both within and outside the organization
- Ability to work independently while exercising sound judgment and decision-making within established practices and policies

Please arrange an appointment for further details [...]
and send us your documents (CV) in advance.