Regional Clinical Trial Manager

🕒 March 13

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🧪 Clinical Research

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Prilenia

WebsiteLinkedInAll Job Openings

11 - 50 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 $43M Series B on 2021-11

Biotechnology • Pharmaceuticals • Healthcare Insurance

Prilenia is dedicated to developing new treatments for patients and families facing neurodegenerative diseases and neurodevelopmental disorders, such as Huntington’s disease and amyotrophic lateral sclerosis (ALS). They focus on harnessing the brain's neuroprotective capabilities, particularly through the activation of the sigma-1 receptor (S1R), to restore impaired pathways in the brain. Prilenia is advancing scientific research and exploring potential treatments to provide hope and improve the lives of patients and their families.

📋 Description

• Responsible for the oversight and management of operational activities in given regional area. Including but not limited to: multi studies regional supervision from Phase I-III, multi centers visits Ad Hoc. • Develop and oversee procedures for dealing with troubleshooting and problem solving. • Establish and monitor programs/protocols/procedures. Including but not limited to: supervision of full protocol procedures on site, joining Trainings and Visits on a routine base. • Support the evaluation of suitability of site personnel and facility for initial and ongoing conduct of clinical trial • Maintain appropriate and effective communication with vendors and other internal departments to ensure successful project completion • Build and sustain strong cross-functional relationships across diverse global teams; foster a culture of mutual accountability, collaboration, and innovation. • Communicate progress, risks, and strategic insights to executive leadership and governance committees, supporting data-driven decision-making and program advancement.

🎯 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.