Senior Clinical Project Manager

🔥 7 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $140k - $150k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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Alira Health

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 $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.

📋 Description

• 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 CPMs and provide guidance to CPMs • Create and review clinical study documents, protocols, ICF templates, budgets, site templates, manuals, plans, and binders • Drive clinical teamwork and communications to achieve trial milestones • Provide accurate reports and work products and monthly billing information to finance • Present at investigator meetings and new client meetings • Update management through frequent communication • Identify issues and develop strategies to meet study timelines • Manage subject accrual, retention, and compliance • Assist with TMF management and reviews • 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 • 10 years of experience in the pharmaceutical / biotechnology / CRO industry with at least 5 years of clinical project 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 • Permanent authorization to work in the U.S. • Bachelor's degree in Biology, Biotechnology, Life Sciences, Pharmacy, or related field, or equivalent experience