Senior Clinical Research Associate

🔥 0 minutes ago

🌐 Sweden, Denmark – Remote

🇸🇪 Sweden – Remote 🇩🇰 Denmark – Remote

⏱ Part Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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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

• Conduct site monitoring responsibilities independently for clinical trials • Provide oversight, leadership, and guidance to CRA teams • Ensure adherence to project scope, SOPs, timelines, budgets, protocol, and GCP requirements • Review monitoring visit reports and conduct co-monitoring and evaluation visits • Coordinate cross-functional resolution of clinical trial monitoring issues • Assist with Monitoring Plans, training presentations, ethics documentation, and site contract negotiations • Perform qualification, initiation, interim, and close-out visits remotely and onsite • Prepare accurate monitoring visit reports covering site problems, resolutions, protocol deviations, study progress, and enrollment • Review source documents and verify CRF data integrity • Perform quality control of eTMF/TMF documents and investigational product accountability • Review site regulatory binders and maintain contact with study sites • Monitor patient accrual and respond to sponsor requests • Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs • Resolve discrepant data queries with CRAs/CTC and data management • Identify site issues and develop problem-solving strategies • Prepare sites for audits • Participate in internal, client/sponsor, scientific, and other meetings • Train and mentor new CRAs • Collaborate on CTMS development and maintenance • Provide monthly billing information and manage study budgets for stand-alone projects • Manage conflicting priorities and perform additional assigned duties

🎯 Requirements

• Minimum 4 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry • Ability to autonomously manage monitoring activities • Oncology experience • Availability to travel in Denmark and Sweden • Fluent in Danish, Swedish and English • Quality focused; careful, thorough, and detail-oriented • Strong organizational skills and ability to multi-task in a fast-paced environment • Ability to manage priorities, organize time, and solve problems • Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills • Ability to travel and manage stress • Professional, trustworthy, and disciplined • Ability to solve unstructured or ambiguous challenges • Strong command of local language and English for EU monitoring activities • Excellent communication and interpersonal skills with customer service orientation • Good computer skills, including clinical trial management systems, clinical trial databases, and electronic data capture • Knowledge of clinical research, ICH GCP, local regulations, regulatory and ethical requirements • Ability to establish and maintain positive relationships with sponsors, sites, and project team members • Graduation in a scientific health field • Bachelor's degree in Biology, Biotechnology, Life Sciences, Pharmacy, or related scientific health field

🏖️ Benefits

• Remote work arrangement • Part-time schedule • Contingency Workforce contract