Clinical Research Manager

2 months ago

New York, United States Masis Professional Group Full time

CLINICAL RESEARCH MANAGER (Hybrid in NYC)


Our client has an exciting new position for a Clinical Research Manager for a Phase 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


MUST HAVES:


  • Phase III experience in the US.
  • Regulatory and FDA Communication Experience: Candidates must have hands-on experience with FDA submissions and audits, ideally within global trials, to ensure strong regulatory compliance.
  • IND submission experience.
  • Startup Experience: We’re looking for candidates familiar with the fast-paced, hands-on nature of startups.
  • Clinical Science Experience: Strong clinical science knowledge is key, in addition to operational skills, to contribute to decision-making in clinical trials.
  • RFP and Budget Management: Experience in reviewing RFPs and managing budgets is crucial for project and financial oversight.
  • CRO and Vendor Management: The ability to manage external CRO relationships is important, especially for ensuring smooth outsourced operations.


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.
  • 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 with FDA and US requirements for the conduct of clinical studies is a must.
  • Phase II and Phase III experience in the US is required.
  • 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

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