Clinical Research Manager

4 weeks ago


New York, New York, United States Masis Professional Group Full time
Clinical Research Manager

We are seeking a highly skilled Clinical Research Manager to join our team at Masis Professional Group. As a key member of our clinical development team, 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 with relevant experience.
  • 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.

We Offer:

  • Multi-disciplinary international project management managing diverse relationships.
  • 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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