
501 - 1000 employees
đĽ Healthcare
đ Manufacturing
âď¸ Healthcare Insurance
đ° $58M Venture Round on 2023-01
Healthcare ⢠Manufacturing ⢠Healthcare Insurance
Alira Health is a global consulting firm that partners with life sciences companies to develop innovative solutions in healthcare. The company specializes in a wide range of services including research and clinical development, regulatory compliance, and management consulting. Alira Health focuses on patient engagement, market access, and providing real-world solutions to improve patient outcomes. They are committed to environmental sustainability and actively participate in community involvement and ESG initiatives. Alira Health also provides technology solutions with a focus on improving life sciences research through empathy and scientific excellence.
đĽ 36 minutes ago
đ Massachusetts â Remote
đľ $115k - $145k / year
â° Full Time
đĄ Mid-level
đ Senior
đĽ Clinical Operations
đŚ H1B Visa Sponsor
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501 - 1000 employees
đĽ Healthcare
đ Manufacturing
âď¸ Healthcare Insurance
đ° $58M Venture Round on 2023-01
Healthcare ⢠Manufacturing ⢠Healthcare Insurance
Alira Health is a global consulting firm that partners with life sciences companies to develop innovative solutions in healthcare. The company specializes in a wide range of services including research and clinical development, regulatory compliance, and management consulting. Alira Health focuses on patient engagement, market access, and providing real-world solutions to improve patient outcomes. They are committed to environmental sustainability and actively participate in community involvement and ESG initiatives. Alira Health also provides technology solutions with a focus on improving life sciences research through empathy and scientific excellence.
⢠Manage clinical research studies according to 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 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 manage 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 as required ⢠Perform additional duties as assigned
⢠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, yet less structured team environment ⢠Ability to problem-solve unstructured or ambiguous challenges ⢠Strong command of English, both 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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