Prilenia is hiring a Regional Clinical Trial Manager - East Coast, US

Responsibilities

• Oversee and manage operational activities in the assigned regional area, including multi-study supervision from Phase I-III and multi-center visits.
• Create and manage procedures for troubleshooting and problem-solving.
• Develop and monitor programs, protocols, and procedures, including full protocol supervision on-site and routine training visits.
• Assess the suitability of site personnel and facilities for initial and ongoing clinical trial conduct.
• Maintain effective communication with vendors and internal departments to ensure project success.
• Build and maintain strong cross-functional relationships across global teams, fostering a culture of accountability, collaboration, and innovation.
• Report progress, risks, and strategic insights to executive leadership and governance committees, supporting data-driven decision-making and program advancement.

Requirements

• Bachelor’s degree in science, nursing, life sciences, biomedical discipline, or equivalent.
• Minimum 7-10 years of clinical research experience as a CRA or equivalent, with 3 years of clinical project management or operations management experience.
• Proven experience in clinical monitoring and/or data management.
• Recent experience leading global Phase 3 studies from start to finish.
• Experience with rare diseases.
• Strong understanding and application of FDA guidelines, Good Clinical Practices (GCP), ICH, and applicable Standard Operating Procedures.
• Strong project management, stakeholder management, and communication skills, including influencing executive leadership, cross-functional partners, and external collaborators.
• Exceptional situational awareness in communication, adapting tone, content, and detail to suit the audience.
• Excellent problem-solving and decision-making skills.
• Proven budget management skills.
• Ability to work independently, prioritize tasks, and manage multiple projects in a matrix team environment, including managing CROs and other vendors to meet or exceed KPIs.
• Proficiency with clinical research technologies and platforms (EDC, eTMF, IWRS, CTMS, etc.), plus strong skills in Microsoft Office and data analysis tools.

Nice to Have

• Advanced degree.
• Experience with ALS or HD.

Compensation

Not specified

Work Arrangement

On-site with up to 50% travel (regional)

Team

Matrix global team environment

Team

Structure: matrix global team environment

Other

• Willingness and ability to travel (domestic & international) and operate flexibly in virtual teams and global time zones.
• Flexible schedule with interactions across North America, Europe, and Israel time zones.

Not specified