Leading orphan lung drug company developing targeted lung therapies for unmet medical needs, often where the current therapy is intrusive or uncomfortable. (currently with 3 products in or about to begin Phase III clinical trials.
The Clinical Trial Manager serves as the project manager for selected phase I-III trials. This position will report to the Head of Clinical Operations and will, primarily, be responsible for overseeing Vendors, Contract Research Organizations (CROs), Clinical Research Associates (CRAs) and clinical trial sites in North America.
- Assess operational feasibility in North America for assigned trials.
- Participate in vendor identification and selection and provide oversight of vendors, including CROs and other vendors related to the trial including central labs
- Prepare study and site related manuals and documents.
- Contribute to development and management of study budget
- Develop and negotiate site budgets and contracts
- Manage study timelines and oversee study deliverables
- Organize and lead study related meetings including organizing investigator meetings
- Train clinical site and monitoring staff
- Oversee monitoring of the clinical trial, including review of monitoring reports and perform sponsor oversight visits
- Participate in sponsor oversight activities, including risk management, data review, and maintaining study related oversight trackers.
- Oversee the submission of clinical trial documents to the TMF.
- Participate in optimization of clinical trial procedures and updates to SOPs.
- May be responsible for mentoring less experienced staff on the study team.
- Bachelor’s or master’s degree in relevant educational areas, Pharmacy, Nursing, etc.
- Minimum of 5 years of experience in a similar position
- Extensive clinical operations experience managing previous multi-center, clinical trials
- Ability to work well within a global/cross functional project team
- Strong computer skills with the ability to be effective in a paperless office
- Strong understanding of GCP, ICH, and local regulatory requirements
- Highly structured mindset, strong planning and organization skills, acute attention to detail
- High energy with a passion for getting things done and managing projects to completion
- Ability to challenge the status quo and identify better ways to work and achieve goals
- Team player with a “we” mentality
- Takes pride in high-quality work
- Ability to travel up to 30% some may be international