Dedicated to developing new treatments for neurodegenerative diseases and neurodevelopmental disorders.
Regional Clinical Trial Manager
Location
Massachusetts
Posted
6 days ago
Salary
Not specified
Seniority
Lead
Job Description
Job Requirements
- Bachelor’s degree required, preferably in science, nursing, other life sciences, biomedical discipline, or equivalent. Advanced degree preferred.
- Minimum 7-10 years clinical research experience as a CRA or equivalent, such as research coordinator with of 3 years of clinical project management experience or Operations management or equivalent.
- Demonstrated Clinical Monitoring and/or Data Management experience required.
- Recent experience in leading the conduct of global phase 3 studies from start to completion required.
- Experience with rare diseases required Experience with ALS or HD highly preferred Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices (GCP), ICH and applicable Standard Operating Procedures.
- Strong project management skills, stakeholder management and communication skills, including influencing executive leadership, cross-functional partners, and external collaborators.
- Excellent problem-solving and decision-making skills.
- Demonstrated Budget management skills required.
- Ability to work independently, prioritize and work within a matrix team environment is essential. Ability to work across multiple projects with demonstrated ability to manage CROs (and other vendors) to meet or exceed KPIs tied to corporate goals and hold them accountable if they fall behind.
- Proficiency with clinical research technologies and platforms (EDC, eTMF, IWRS, CTMS, etc.), plus strong skills in Microsoft Office and data analysis tools.
- Willingness and ability to travel (domestic & international) and operate flexibly in virtual teams and global time zones. Travel up to 50% (regional).
Benefits
- Flexible schedule with interactions across North America, Europe and Israel time zones
- Encourages team members to work in the ways that make them most effective
- Fostering a diverse, inclusive, and welcoming workplace for all.
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