This range is provided by Masis Professional Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$155,000.00/yr - $175,000.00/yr
Additional compensation types
Annual Bonus
Direct message the job poster from Masis Professional Group
National Life Sciences Recruiter based in Greater Boston
CLINICAL RESEARCH MANAGER (Hybrid role)
*Candidate MUST live a commutable distance by car or train to downtown NYC.
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:
Coordination and implementation of phase III related activities with internal (EU development team, study physician) and external partners (e.g., biostatistics, reimbursement, regulatory).
Independent, quality-assured, and timely planning, coordination, implementation, monitoring and evaluation of international, multicenter phase III study in the USA.
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)
Coordinating and crafting of interim reports and final study reports
Support activities for the New Drug Application of their radiopharmaceutical tracers in the US.
Monitoring and compliance with quality and budget targets (in cooperation with the European Clinical Department)
Supervision (remote and in-person) of participating study centers
Presentation of the company at scientific congresses
Preparation and follow-up of internal and external meetings and reporting
Strong interaction with Departments in Germany to cross-link European activities to the Clinical development in the USA.
Approximate 20% travel time
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.
Proactive, reliable, and goal-oriented work ethic, attention to detail.
Very good written and spoken English. German is a plus. A work permit in USA is a must.
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.
Proactive, reliable, and goal-oriented way of working
Agile thinking and acting, interest in new topics in an ambitious pharmaceutical company that maintains its start-up spirit.
They 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 (e.g., hybrid working) 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.
Exciting job opportunity with project responsibilities and freedom for professional growths and acquisition of new skills
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Science and Research
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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