Clinical Research Manager Jobs

CLINICAL RESEARCH MANAGER

(Hybrid in greater Boston is preferred but will consider remote for the right candidate)

Our client has an exciting new position for a Clinical Research Manager for a Phase II and III clinical study in the field of Nuclear Medicine and Oncology in the USA. The company is expanding their clinical development program of new Radiopharmaceuticals from Europe to the USA. If you want to become a part of our young and motivated team and if you are ready for a new challenge, we are looking forward to receiving your resume!

Job Summary:

• Presentation of the company at scientific congresses
• Monitoring and compliance with quality and budget targets (in cooperation with the European Clinical Department)
• Supervision (remote and in-person) of participating study centers
• Preparation and follow-up of internal and external meetings and reporting
• Coordination and implementation of phase III related activities with internal (EU development team, study physician) and external partners (e.g., biostatistics, reimbursement, regulatory).
• Preparation (in collaboration with the clinical development team) of development plans, study protocols, study-related supporting documents as well as regulatory documents (CTAs, IND, Investigator's Brochure, briefing book documents)
• Independent, quality-assured, and timely planning, coordination, implementation, monitoring and evaluation of international, multicenter phase III study in the USA.
• Coordinating and crafting of interim reports and final study reports
• Approximate 20% travel time
• Support activities for the New Drug Application of their radiopharmaceutical tracers in the US.
• Strong interaction with Departments in Germany to cross-link European activities to the Clinical development in the USA.

Job Requirements:

• Minimum of a Bachelor degree, Ph.D. preferred, in medical or natural sciences or equivalent education/experience in the medical or natural science subjects.
• Minimum of 5 years' experience working in a Clinical Research Manager or Clinical Project Manager role with relevant experience.
• Ability to manage multiple projects in parallel and prioritize across study, regulatory, and company goals.
• Very good written and spoken English. German is a plus. A work permit in USA is a must.
• Strong industry experience in the field of clinical studies in the USA is a must, whereas experience with radiopharmaceuticals, endocrinology or oncology is highly desirable.
• Experience with FDA and US requirements for the conduct of clinical studies is a must.
• Agile thinking and acting, interest in new topics in an ambitious pharmaceutical company that maintains its start-up spirit.
• Phase III experience.
• Proactive, reliable, and goal-oriented work ethic, attention to detail.
• Proactive, reliable, and goal-oriented way of working

They offer:

• We offer a dynamic and ambitious environment with a wide variety of learning and development opportunities.
• Incentives include a flexible working environment (e.g., hybrid working) and a steep learning curve in radiopharmaceutical research in an agile team.
• Multi-disciplinary international project management managing diverse relationships.

Benefits:

• Performance Bonus
• 401K
• 17 days PTO to start plus holidays
• Exciting job opportunity with project responsibilities and freedom for professional growths and acquisition of new skills
• Healthcare benefits and more.