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Clinical Project Manager

2 months ago

Ann Arbor, Michigan, United States ONL Therapeutics Full time
About the Role

We are seeking a highly skilled Clinical Project Manager to join our team at ONL Therapeutics. As a Clinical Project Manager, you will be responsible for overseeing the conduct of clinical studies at various sites and providing operational and management support to ensure the successful delivery of assigned clinical programs.

The ideal candidate will have a strong background in clinical development and clinical trials, with experience in managing projects from initiation to close-out. You will be responsible for coordinating with external vendors and partners, tracking study progress, and ensuring compliance with regulatory requirements.

This is a full-time, on-site position located at our Ann Arbor headquarters office. Occasional after-hours work may be required due to global time zones.

Key Responsibilities:
  • Provide clinical study expertise and support from study start-up to close-out in accordance with regulatory compliance
  • Maintain projects within pre-defined timelines
  • Collaborate with external vendors and partners on the following activities:
  • Point of contact with study CRO for study start-up, conduct and close-out
  • Responsible for coordinating the delivery of quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures, Good Clinical Practice, and regulatory requirements
  • Monitors site progress and initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to leadership
  • Actively participate in Investigator's Meetings as trainer of selected topics
  • Create and maintain project-related documents, plans, and processes; reassess and course-correct, as needed
  • Perform site visits as needed
  • Participate in ongoing review of study data
  • Actively engage in teleconferences/meetings, including tracking and following-up on key action items
  • Liaise with vendors participating in the program(s)
  • Track study progress, invoices, and other project management tasks
  • Escalation of issues to the CRO, Director of Clinical Operations and/or COO, as appropriate
  • Organize in-house portions of clinical studies including, but not limited to:
  • Planning the clinical study supplies necessary for project implementation
  • Create and implements study-specific clinical monitoring tools and documents
  • Assist with compiling and analysis of study data
  • Tracking/management of study progress, payments, and other project tasks.
About You
  • Bachelor's degree in nursing or life sciences.
  • 5+ years of work experience in clinical development/clinical trials
  • Experience with various study systems (EDC, reading center portals, etc.) used in clinical trials
  • Detail-oriented and meticulous in all aspects of work
  • Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
  • Professional demeanor and strong communication skills with the public as well as collaborators and physicians/researchers
  • Self-starter with solid leadership skills, ability to work well independently as well as in team environment
  • Possess the ability to work well under pressure, multi-task, be flexible, and manage deadlines
  • Solid communication and computer skills required e.g., proficient in Microsoft Office Word, Powerpoint and Excel
Why Work with Us?
  • Compensation includes salary, bonuses and stock options.
  • Benefits include health, vision and dental insurance plans, 401(k), holidays and vacation.
  • Hybrid schedule with the flexibility to WFH on Mondays and Fridays.