Clinical Project Manager

The Clinical Project Manager responsible for independently managing multiple clinical studies of moderate complexity or managing a broader range of activities on large multi-center studies. The Clinical Project Manager is expected to address site and vendor related issues, with assistance as needed.

Key Responsibilities:

• Responsible for managing approved study budget(s)
• Develops and oversees study operational plan(s)
• Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical studies
• Assists with protocol design and strategy and medical issue resolution
• Participates in study data review and assists with patient narrative writing and other data review activities as assigned
• Contributes significantly to relevant study documentation including clinical protocols, statistical analysis plan, and clinical study reports
• Proactively identifies project risks and resolves with some supervision
• Participates in the selection of Investigators and vendors
• May mentor more junior Clinical Operations Staff or participate in the onboarding of new personnel
• Represents Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of team
• Ensures assigned studies adhere to all applicable regulations and requirements relevant to the study phase, design and/or use of data.
• Performs other duties as assigned

Preferred Qualifications

• Strong study management track record showing clear proficiency in clinical project management skills.
• Solid vendor management skills
• Broad understanding of operations including those in related development functions
• Demonstrates detailed understanding of clinical protocol, intended study populations as well as solid overall drug development
• Demonstrates ability to effectively interface with key medical personnel at clinical site(s)
• Demonstrates ability to lead multi-disciplinary teams
• Demonstrates ability to flag processes that may not be appropriate for study based on phase, design, and/or use of data
• Maintains a flexible, can-do approach to address issues proactively and innovatively
• Possesses excellent written and oral communications skills

Minimum Qualifications

• M. S.(or equivalent experience) and 4+ years of relevant work experience or B. S. (or equivalent experience) and 6+ years of relevant work experience