Senior Clinical Trial Manager

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🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Peptilogics

WebsiteLinkedInAll Job Openings

11 - 50 employees

🧬 Biotechnology

🏥 Healthcare

🤖 Artificial Intelligence

💰 Grant on 2022-01

Biotechnology • Healthcare • Artificial Intelligence

Peptilogics is a clinical-stage biotechnology company revolutionizing the discovery and development of novel peptide therapeutics for serious and life-threatening diseases. By combining the untapped potential of peptide biology with the capabilities of machine learning, the company aims to enhance drug design and develop precision-engineered peptide treatments. Its lead peptide therapeutic, PLG0206, is currently under investigation for treating prosthetic joint infections, addressing significant unmet medical needs.

📋 Description

• Manage day-to-day operations of clinical trials with internal cross-functional study teams and CRO team members • Facilitate internal team meetings and provide study status updates • Serve as the CRO's primary point of contact for study startup, monitoring, site management, and close-out activities • Anticipate project needs and take decisive action • Monitor, track, and report site and study performance metrics, budgets, and timelines • Review issues with Clinical Operations and take corrective steps • Review monitoring trip reports and provide feedback to the CRO • Ensure compliance with GCP, ICH, and regulatory requirements • Serve as primary contact for select clinical trial vendors and ensure timely, high-quality deliverables • Provide regular stakeholder updates and reports • Review TMF files for completeness and inspection readiness • Ensure study operations comply with study plans • Collaborate with internal study and CRO teams to prioritize data integrity and participant safety • Monitor quality issues and implement timely quality-control measures • Assist with study-level budget reviews, assessments, and analysis • Perform other duties as assigned

🎯 Requirements

• Strong, clear communication with investigators and site study-team members • Strong organization and follow-through skills • Ability to prioritize and adapt independently as the clinical trial landscape evolves • Independent thinking and nimble action in a fast-paced environment • Proactive approach to assignments and responsibilities • Willingness to ask questions and pursue answers as part of continual learning • Ability to hold team members and self accountable for critical deliverables • Demonstrated experience managing CRO relationships, trial timelines, and study budgets in a sponsor or CRO environment • Proficiency in clinical trial management systems and Microsoft Office applications • Bachelor's degree in life sciences, health sciences, or a related field • Minimum of 12 years of clinical research experience • Demonstrated experience in multicenter/multinational late-stage clinical trial management • Working knowledge of GCP, FDA regulations including 21 CFR Part 312, and ICH guidelines • Professional certification such as CCRP, CCRA, or PMP is desirable • Prior experience supporting clinical-stage biotech or startup environments is desirable • Experience with hospital-based clinical trials is desirable • Experience with international/multinational trials is desirable • Experience with Smartsheet is desirable

🏖️ Benefits

• Equal opportunity employer • Travel as required (20-30%), depending on program stage