Senior Clinical Research Manager
24 hours ago
**Overview of Role**
The Clinical Project Manager plays a pivotal role in the success of Intuitive's clinical trials in Europe. As a member of the Clinical Affairs Department, this individual will oversee the initiation, progress, and conduct of clinical studies, ensuring compliance with applicable laws, regulations, and guidelines.
This role requires a strong background in clinical research, with experience in project management, protocol development, and data analysis. The ideal candidate will possess excellent communication and interpersonal skills, with the ability to work independently and collaboratively as part of a team.
Responsibilities:
- Oversee the management of clinical studies, including project development, budgeting, and investigator selection.
- Develop and implement study protocols, case report forms, informed consents, and clinical trial agreements.
- Organize and coordinate Competent Authority and Ethics Committee submissions, ensuring timely and successful outcomes.
- Manage ongoing study activities, including enrollment, safety reporting, and troubleshooting.
- Work closely with data management and statisticians to ensure high-quality data and timely results.
- Ensure compliance with corporate and regulatory requirements, including GCP, ISO-14155, and MDR.
- Lead audits and prepare for regulatory inspections, ensuring readiness and preparedness.
- Develop and maintain relationships with Contract Research Organizations (CROs) and external partners, identifying suitable partners and developing contracts or work charters.
- Manage and support CRAs, overseeing site monitoring visit reports and addressing site trouble-shooting issues.
- Prepare and present project status updates and PowerPoint presentations to internal stakeholders.
- Serve as a liaison between internal and external stakeholders, ensuring effective communication and collaboration.
- Collaborate with cross-functional teams to identify areas for improvement and implement process enhancements.
- Stay up-to-date with changing regulations and guidelines, applying knowledge to ensure compliance and minimize risks.
Requirements:
- Master's degree in Life Sciences, Medicine, or related field.
- Minimum 3 years of experience in clinical research, with a proven track record in project management.
- Knowledge of medical device regulations and guidelines, including GCP, ISO-14155, and MDR.
- Experience with protocol and CRF development, data analysis, and statistical programming.
- Excellent communication, interpersonal, and leadership skills.
- Ability to work effectively in a fast-paced environment, prioritizing tasks and managing multiple projects simultaneously.
- Fluent English language proficiency, with a second European language an advantage.
- Willingness to travel up to 25% throughout Europe.
Benefits:
Intuitive offers a competitive salary range of €80,000 - €110,000 per annum, depending on experience. Additionally, the company provides a comprehensive benefits package, including health insurance, retirement plan, and paid time off. Intuitive is an equal opportunity employer and welcomes applications from qualified candidates.
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