Daniel Volk

About Daniel Volk

Accomplished Clinical Research Professional with over 8 years of industry experience managing and monitoring clinical trials. Meticulously projected and maintained study budgets, managed vendors, and navigated database locks. Exemplary cohort management in dose escalation trials. Developed and amended various study documents. Lead audit response teams. Continuous history of mentorship and synergistic leadership. Monitored Phase I-IV trials across multiple therapeutic areas. Experienced in conducting QVs, SIVs, IMVs, and COVs with a comprehensive understanding of feasibility, site selection and activation, regulatory document collection, study metrics tracking, EDCs and EMRs, study timelines and deliverables, project management, and ICH/GCP. Therapeutic Areas: •Solid Tumor Oncology: GEP-NETs, Prostate Cancer, Metastatic Triple Negative Breast Cancer, HER2-/HR+ Metastatic Breast Cancer, ES-SCLC •Hematology Oncology: Multiple Myeloma, Leukemia, Lymphoma •Infectious Disease: Staph Infections of Bone and Joints •Immune Mediated Inflammatory Disease: Crohn\'s Disease •Endocrinology: Low Testosterone •Rare Diseases: Pompe Disease •QT/QTc Interval Evaluation

Experience

1. Senior Manager, Clinical Site Operations

   Rayzebio

   Apr 2022 — Present · Nashville, TN, US

   Assists in the oversight and management of assigned clinical sites and studies. This includes ensuring site execution of studies in accordance with RayzeBio SOPs, ICH Guidelines, and Good Clinical Practices (GCP) to ensure overall data quality, integrity, and patient protection • Oversight of CRO CRA work to ensure the appropriate training of the clinical team and investigators • Oversight of site’s start-up process to ensure timely start-up • Utilize CRO systems to review Monitoring Visit Reports, monitoring visit scheduling, monitoring metrics, protocol deviations, issues, and action items to ensure data quality and facilitating re-training when necessary • Oversight of site payments to ensure completed in a timely manner • Perform review and quality control of trial master file, ensuring overall inspection readiness • Perform review of safety data to ensure all outstanding items are addresses within a timely manner • Proactively identify, prevent, and mitigate site-specific study-related risks • Summarizes clinical site performance data and escalates risk to the Sr. Director CSO and SVP, Clinical Operations as needed • Contributes to the development, review and approval of site and study documents including but not limited to RayzeBio SOPs and Clinical Operation Plans • Conduct site visits to foster site relationships with RayzeBio, address poor performance, increase site interaction and enrollment, and further ensure adequate oversight of study execution • Serve as the direct sponsor contact for sites • Has skills and expertise in oversight, mentoring and coaching of CRAs

Education

• Shippensburg University of Pennsylvania

  Bachelor of Science (B.S.), Human Biology

  2008 — 2012