Clinical Research Manager
Hybrid-Boston site Company
Our client develops PET/CT imaging as a diagnostic tool in patients with Primary Aldosteronism (PA), one of the most common causes for secondary hypertension. What you will be doing
What you will bring to the table
- Manage a phase 2/3 clinical study in the field of nuclear medicine and oncology
- Extend the clinical program with PET/CT imaging in patients with PA to the USA (In Europe, a phase III clinical study has already been established.)
- 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 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
- Ph.D. in medical or natural sciences or equivalent education/experience in the medical or natural science subjects.
- 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, 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, whereas phase III experience is highly desirable.
- 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.
- Excellent communication skills. Team player with good negotiation skills
- Sound knowledge of the usual MS Office software
We are offering:
- 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.
If you'd like to learn more about this great opportunity, please email Kiera Kelleher at Kiera@ScientificSearch.com
Reference job# 18008
- Type: Direct Hire
- Category: Medical Device Company
- Date Posted: 2023-08-08