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About the role
- Project Manager overseeing clinical research studies for Alira Health. Managing sponsors, study teams, clinical documentation, compliance, timelines, and trial milestones.
Responsibilities
- Manage clinical research studies in accordance with approved scope of work/budget, ICH GCP guidelines, FDA regulations, and established timelines
- Serve as study lead and primary contact for sponsors
- Manage clinical study functions including investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory
- Generate and present study status updates and reports to sponsors
- Supervise and support Clinical team members, including Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates
- Supervise and train Associate Project Managers
- Create and review clinical study documents, protocols, ICF templates, study budgets, site logs/forms, study manuals and plans, and site binders
- Drive clinical teamwork and communications to achieve trial milestones
- Ensure accuracy of reports and work products
- Provide monthly billing information to the finance team
- Present at investigator meetings and new client meetings
- Update management through frequent communication
- Identify issues and develop problem-solving strategies to meet study timelines
- Manage subject accrual, retention, and compliance
- Assist with TMF management and conduct TMF reviews as needed
- Prepare for and participate in third-party audits and FDA inspections
- Ensure compliance with ICH GCP guidelines, FDA regulations, and company SOPs
- Participate in internal, client/sponsor, scientific, and other meetings
- Perform additional duties as assigned
Requirements
- BS/BA from an undergraduate program (life sciences or related discipline preferred) or equivalent experience
- 3 years of experience in the pharmaceutical / biotechnology / CRO industry with 1 year of management experience
- Proven ability to be careful, thorough, and detail-oriented
- Strong organizational skills and ability to multi-task and work effectively in a fast-paced environment
- Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
- Self-starter who thrives in a collaborative, less structured team environment
- Ability to problem-solve unstructured or ambiguous challenges
- Strong command of English, written and verbal
- Excellent communication and interpersonal skills with customer service orientation
- Proficient with MS Office Suite, particularly Word and Excel
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