Prilenia

Prilenia

Regional Clinical Trial Manager - East Coast, US

Boston, MA · Full-time

Sponsorship not specifiedDetected 131 days ago
GCPData AnalysisProject ManagementStakeholder ManagementOperations ManagementClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationCollaborationProblem SolvingMicrosoft Office

About the role

  • Roles and Responsibilities: - Responsible for the oversight and management of operational activities in given regional area.
  • Location/Time Zones: - This is a full-time, remote position in the US. - Expected domestic/regional travel up to 50% with some international travel. - Flexible schedule with interactions across North America, Europe and Israel time zones.

Responsibilities

  • Develop and oversee procedures for dealing with troubleshooting and problem solving.
  • 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.

Requirements

  • 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.
  • Ability to work independently, prioritize and work within a matrix team environment is essential.
  • Willingness and ability to travel (domestic & international) and operate flexibly in virtual teams and global time zones.

Nice to have

  • Prilenia has a simple but urgent mission - to bring transformative medicines to people affected by devastating neurodegenerative diseases.
  • Experience in rare diseases required, HD and/or ALS preferred.
  • The position will report to the SVP, Head of Clinical Operations.
  • Bachelor's degree required, preferably in science, nursing, other life sciences, biomedical discipline, or equivalent.
  • Advanced degree preferred.
  • Proficiency with clinical research technologies and platforms (EDC, eTMF, IWRS, CTMS, etc.), plus strong skills in Microsoft Office and data analysis tools.

Skills

  • 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.
  • Excellent problem-solving and decision-making skills.
  • Demonstrated Budget management skills required.
  • Location/Time Zones:
  • This is a full-time, remote position in the US.
  • Expected domestic/regional travel up to 50% with some international travel.
  • Flexible schedule with interactions across North America, Europe and Israel time zones.
  • Prilenia is proud to be an equal opportunity employer.
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This listing is sourced directly from Prilenia's careers page and normalized into a canonical job model.