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A global clinical research organization is seeking a Clinical Project Manager to oversee clinical trials from initiation to completion. The role demands strong leadership and project management skills, focusing on rare diseases, oncology, and gene therapies. The ideal candidate will have a bachelor's degree in allied health and at least 6 years of clinical research experience. This position offers a hybrid work model and the opportunity to make a significant impact on treatments for critically ill patients.
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization focused on advancing treatments for chronically and critically ill patients.
We support clinical research throughout the life cycle of development, from drug concept to commercialization.
Plan, implement, evaluate, and complete full execution of assigned clinical trials, often acting as global trial lead.
Set goals, timelines, and provide oversight and positive leadership to motivate the team to achieve high-quality outcomes.
Coordinate operational aspects to ensure compliance with ICH guidelines, Good Clinical Practice, and regulatory requirements.
Manage full-scope clinical trial projects, including global trials from start-up through analysis phase, and oversee functionally assigned team members.
Control project budget, assess profit margins, and collaborate with trial-assigned directors to maintain budget alignment.
Prepare, review, and update trial plans, timelines, schedules, resources, and budgets.
Maintain clear communication with vendors, ensuring timely delivery and financial oversight.
Oversee Clinical Research Associate (CRA) activities, including site monitoring and data review.
Lead client and team meetings, ensuring documentation of decisions and outcomes.
Provide oversight of the Clinical Trial Master File (TMF) to ensure compliance and completeness.
Participate in business-development activities and process-improvement initiatives.
Mentor other CPM staff.
Preparation and negotiation of site budgets, site payments, and payment of site invoices handled by the EU Clinical Trial Budget Management Team with assistance of regional CRAs or Study Start-up Specialists.
Provide expertise and support for country-specific regulations and submissions.
Conduct regional feasibility activities for trial and RWE work.
Conduct RWE activities as needed in the region.
Provide Importer of Record services as needed.
Provide expertise and support for country-specific regulations and submissions.
Conduct regional feasibility activities and RWE work.
Provide expertise and support for country-specific regulations and submissions.
Conduct regional feasibility activities and RWE work.
Bachelor's degree in allied health (e.g., nursing, pharmacy, health science) with clinical trial management experience or equivalent education and work experience.
Minimum 6 years of clinical research experience (CRO CRA, research manager, or similar).
Project-management experience in a clinical setting is acceptable.
Graduate degree preferred.
At least 5 years of experience focused on rare disease, oncology, cell-gene therapy, or transplant.
Experience as a Clinical Project Manager or Clinical Trial Manager preferred.
Eligibility to live and work in Argentina, Brazil, or Mexico.
Advance your career through a structured mentoring program and leadership courses.
Work in an award-winning, collaborative culture with hybrid work options.
Make a lasting impact by advancing treatments for critically ill patients.
We use a secure email domain @ctifacts.com for any direct communication during the hiring process.
Applications should be submitted directly through our website or verified LinkedIn page.
Hiring Safeguards – We will never contact you via Microsoft Teams, text message, or ask for bank-account information during recruitment.
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