• Execute deliverables of all aspects of assigned clinical studies, including, but not limited to, investigator selection, vendor selection, study startup activities and site initiation, preparation of study documentation, including protocols, consent documents, laboratory manuals, biospecimen tracking, clinical data oversight, and closeout activities. • Manage, lead and mentor clinical study support staff (CRAs, CTAs) as needed. • Participate in soliciting and reviewing vendor/clinical site proposals and budgets, and subsequent selection, contracting, invoicing, and management of study vendors and/or CRO(s) as required. • Collaborate with other clinical trial managers on the team to determine lessons learned and implement best practices across all clinical programs. • Provide regular updates of study progress to key internal stakeholders. • Proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues, as needed. • Identify barriers to timely and successful study execution and propose solutions. • Provide monitoring oversight by reviewing monitoring schedules, metrics, and reports. May oversee or manage clinical documentation and monitoring reports. May be responsible for conducting on-site initiation visits and interim monitoring visits and creating applicable documentation. • Contribute to clinical study feasibility and timeline assessments. • Ensure compliance with all applicable regulatory requirements by monitoring compliance with all company standard operating procedures (SOPs), FDA regulations, GCP guidance, and applicable international regulations concerning clinical activities. • Establish and maintain effective working relationships with coworkers, managers, and clients/customers.