• Coordinate and oversee the operational aspects of a study including planning, start-up, enrollment and close out activities ensuring that deliverables are completed on time, within budget, and in compliance with department procedures, applicable regulations and quality standards • Prepare, review and implement study related plans and documents including project timelines, study protocols, informed consent forms (ICFs), recruitment plans, monitoring plans, study budgets, site contracts & budgets, vendor management plans and other essential clinical study documents • Develop plans for systems and materials required to support the efficient execution of clinical studies and is responsible for effective management during the conduct of the study • Develop, implement and maintain tools to manage, monitor and report on study health & operations, project timelines, and study finances to department management and other stakeholders • Participate in study database development by reviewing and contributing to case report form (CRF) design, CRF completion guideline development, edit check & manual data review requirements, and participation in user acceptance testing (UAT) • Oversee sample management activities including planning, sample handling, kit supply management, sample shipping, processing, and resulting • Develop site recruitment plans and is responsible for the identification, selection, start-up and performance monitoring of clinical research sites • Develop study budgets and is responsible for accurately forecasting and managing study expenses • Oversee site contracting and study budget management including facilitation of site contract and budget negotiations, invoice review and approval, accrual management and maintenance of budget tracking tools • Oversee study and site management activities such as, training, data entry & query resolution, TMF maintenance, and ensure compliance with study plans such as the study protocol, monitoring plans, and recruitment plans • Conduct monitoring activities as needed • Ensure the smooth and efficient closure of studies through development of plans for completion of data verification & review, planning & facilitation of database lock activities, determination of site & IRB/EC readiness for closure, statistical analysis and clinical study report development • Participate in the identification, qualification, selection and management of vendors providing support to clinical studies • Provide oversight and support for assigned clinical operations study team members • Leads cross-functional team meetings, ensuring study goals and priorities are clear. • Professionally interacts with investigators and site staff, vendors, key opinion leaders and consultants • Ability to identify, mitigate and manage study risks • Responsible for maintaining ongoing study audit readiness and participates in internal or regulatory authority audits • Provide guidance and support to less experienced team members • Fosters a collaborative and knowledge-sharing environment, promoting continuous learning within the team • Ability to provide oversight to multiple studies • Participate or may facilitate department or project initiatives under the direction of department management or lead clinical trial manager • Uphold company mission and values through accountability, innovation, integrity, quality and teamwork • Support and comply with the company’s Quality Management System policies and procedures • Maintain regular and reliable attendance • Ability to act with an inclusion mindset and model these behaviors for the organization • Ability to work a designated schedule • Ability to work on a mobile device, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day • Ability to work on a computer and phone simultaneously • Ability to travel 20% of working time away from work location, may include overnight/weekend travel. • Ability to attend off-site meetings and conferences as needed