ASSOCIATE CLINICAL TRIAL MANAGER

ABOUT US 
Calibr-Skaggs Institute for Innovative Medicines, a division of Scripps Research, is a first-of-its-kind, nonprofit translational research institute dedicated to creating the next generation of medicines. Calibr-Skaggs was founded on the principle that the creation of new medicines can be accelerated by pairing world-class biomedical research with state-of-the-art drug discovery and development capabilities.  Scripps Research is ranked one of the most influential institutions in the world for its impact on innovation. Our educational and training programs mold talented and committed students and postdocs into leading edge scientists. Leveraging the unique scientific environment of Scripps Research, impacting translational sciences, Calibr-Skaggs has created a portfolio of drug candidates, and is shaping a new paradigm for advancing nonprofit biomedical research to impact patients while re-investing in further innovative research. We expand basic knowledge in the biosciences and use these fundamental advancements to develop profound innovations that improve wellbeing. Calibr-Skaggs’ drug development portfolio spans a broad range of human diseases, including cancer, autoimmunity and inflammatory diseases, metabolic and cardiovascular diseases, infectious and neglected diseases, as well as age-related and degenerative diseases. If you have a passion for making a difference, this could be your opportunity to join our transformative team.

Position Summary

The Associate Clinical Trial Manager supports the internal Calibr Clinical team, clinical site teams and CRO/vendor partners in execution of early-phase clinical trials across multiple therapeutic areas.  Focus on immuno-oncology and a wide range of programs covering neurodegeneration, metabolic disorders, autoimmunity, and others. Assists in the execution of complex clinical programs, participates in the design and planning of clinical studies, and delivers successful operational outcomes across multiple Phase 1 and 2 clinical trials. The Clinical Trial Manager will apply their excellent operational capabilities as the main driver for project delivery within timelines and budget in accordance with the protocol while ensuring compliance with ethical and regulatory requirements.

Responsibilities and Duties

• Deliver operational excellence.
• Support coordination of clinical operations required to initiate, execute, and complete clinical trials to drive on-time delivery of milestones.
• Support Calibr Clinical team functions.
• Develop and maintain active clinical trial documents including protocols, informed consent forms, case report forms, operational plans.
• Assist in set-up and maintenance of clinical trial documentation including preparation for audits, final reconciliation, and archives.
• Conduct data review and assist in identification of data discrepancies while engaging vendors, CROs and site personnel in resolution as needed.
• Monitor and/or co-monitor clinical trials sites, as necessary.
• Support audit activities including inspection readiness.
• Track investigational supplies, specimens, imaging.
• Support vendor selection and CRO activities.
• Collaborate with internal team members, Contract Research Organizations, and vendors on all deliverables.
• Perform all duties and responsibilities in accordance with CFR, GCP/ICH Guidelines, SOPs, and other applicable guidelines.
• Contribute to process improvement initiatives, departmental projects, development, and maintenance of Standard Operating Procedures (SOPs).

Position Requirements

• Minimum BA/BS or equivalent or relevant and qualifying training and experience.
• 1+ years’ experience in clinical trial support, operations or management experience at a biotechnology or pharmaceutical company or CRO; or other relevant research or project management experience.
• Ability and willingness for minimal travel (approximately 3 days every other month).
• Excellent leadership, communication, and organizational skills.
• Able to take initiative and communicate cross-functional needs and expectations.
• Ability to proactively handle multiple tasks, manage a diverse range of functional activities and solve problems.
• Strong communication and inter-personal skills.
• Highly responsive and proactive.
• Knowledge of CFR and GCP/ICH requirements.
• Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, EDC and eTMF).
• Strong problem resolution and conflict management skills.
• Attention to detail.
• Strongly Preferred: Oncology clinical trial experience.

 PHYSICAL REQUIREMENTS

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