Sr. 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 TITLE: Sr. CLINICAL TRIAL MANAGER

POSITION SUMMARY: 

The Senior Clinical Trial Manager supports the internal Calibr Clinical team and provides operational oversight to clinical stage programs and associated 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. Drives the development and execution of complex clinical programs, including design and planning of clinical studies, and delivers successful operational outcomes across multiple Phase 1 and 2 clinical trials. The Senior Clinical Trial Manager will apply their excellent operational capabilities as the main driver for project development and delivery within timelines and budget in accordance with Calibr Clinical Operation needs while ensuring compliance with ethical and regulatory requirements. 

We have an exciting opportunity for a Senior Clinical Trial Manager at Calibr, a division of Scripps Research, is a first-of-its-kind, nonprofit translational research institute dedicated to creating the next generation of medicines. Calibr 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. 

RESPONSIBILITIES & DUTIES: 

•  Deliver operational excellence.
• Independent and proactive planning, day-to-day management, and oversight of assigned clinical projects, accountable for driving on-time delivery of milestones from initial clinical development through close-out.
• Development of tools for tracking and reporting of project deliverables to internal and external stakeholders.
• Develop and maintain active clinical trial documents including protocols, informed consent forms, case report forms, operational plans.
• Oversight of trial reporting responsibilities and documentation, including annual reports, final reconciliation and archival.
• 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.
• Ensure inspection readiness including oversight of TMF maintenance and audit activities.
• Track investigational supplies, specimens, imaging.
• Lead vendor identification and selection and serve as primary management of vendor activities throughout study lifecycle.
• Adherence to the GCP/ICH Guidelines, SOPs, and other applicable guidelines.
• Lead contract and budget development, negotiation and reconciliation.
• Lead process improvement initiatives and departmental projects.
• Collaborate with department heads on developmen