Clinical Research Manager
2 weeks ago
We are seeking a highly skilled Clinical Research Manager to join our team at Masis Professional Group. As a Clinical Research Manager, you will be responsible for coordinating and implementing phase III related activities with internal and external partners.
Key Responsibilities:
- Coordinate and implement phase III related activities with internal and external partners.
- Plan, coordinate, implement, monitor, and evaluate international, multicenter phase III studies in the USA.
- Prepare development plans, study protocols, study-related supporting documents, and regulatory documents.
- Coordinate and craft interim reports and final study reports.
- Support activities for the New Drug Application of radiopharmaceutical tracers in the US.
- Monitor and comply with quality and budget targets.
- Supervise participating study centers.
- Present the company at scientific congresses.
- Prepare and follow-up internal and external meetings and reporting.
Requirements:
- Minimum of a Bachelor degree, Ph.D. preferred, in medical or natural sciences or equivalent education/experience.
- Minimum of 5 years' experience working in a Clinical Research Manager or Clinical Project Manager role.
- Proactive, reliable, and goal-oriented work ethic, attention to detail.
- Very good written and spoken English. German is a plus.
- Ability to manage multiple projects in parallel and prioritize across study, regulatory, and company goals.
- Strong industry experience in the field of clinical studies in the USA is a must.
- Experience with radiopharmaceuticals is highly desirable.
- Experience in endocrinology/cardiovascular therapeutic space.
- Experience with FDA and US requirements for the conduct of clinical studies is a must.
- Phase II and Phase III experience required.
What We Offer:
- Multi-disciplinary international project management managing diverse relationships.
- We offer a dynamic and ambitious environment with a wide variety of learning and development opportunities.
- Incentives include a flexible working environment and a steep learning curve in radiopharmaceutical research in an agile team.
Benefits:
- Performance Bonus
- 17 days PTO to start plus holidays
- 401K
- Healthcare benefits and more.
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