Clinical Research Manager

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 :

• 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

What you will bring to the table :

• 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

#LI-KK1
#LI-Hybrid

• Type: Direct Hire
• Category: Medical Device Company
• Date Posted: 2023-08-08