Clinical Operations Lead

Job OverviewIndependently direct the execution of the Site & Patient Services (SPS) components of Real World Evidence (RWE) studies by applying clinical research experience and decision making skills to proactively set goals and tangible expectations for SPS project team members.

Essential Functions• Oversee the delivery of Site Management project tasks, providing advice and guidance to help achieve high performance and quality project deliverables.• Develop, implement and maintain the Site Recruitment, SPS Operations and SPS Risk Management Plans within the agreed project strategy.• Ensure overall project efficiency and adherence to project timelines and financial goals; report metrics and out of scope activities.• Collaborate with other functional groups within the company such as data management, quality assurance and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.• Manage and follow study activities through ongoing tracking and review of study progress. Provide input and report progress to appropriate SPS management and project management leaders.• Act as the first line of escalation for site management questions and issues for assigned projects.• Conduct co-monitoring and/or assessment visits to ensure the study is being conducted in accordance with the protocol, SOPs, GCP and applicable regulatory requirements.• Develop and deliver presentations/training to clients, colleagues and professional bodies, as required.• May participate in business development activities such as proposal development and bid defenses.• May be assigned additional responsibilities as needed to support projects and other corporate/departmental initiatives.

Qualifications• Bachelor's Degree preferably in a life sciences discipline, and 4 years of monitoring experience, team leadership experience; or equivalent combination of education, training and experience.•• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.• Skill in understanding and executing complex study designs.• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.• Strong written and verbal communication skills including good command of English language.• Demonstrated team leadership and mentoring skills.• Ability to develop and deliver project and functional training.• Excellent planning, organizational and problem-solving skills.• Ability to manage competing priorities and ensure on-time, high quality delivery of project tasks/responsibilities.• Ability to establish and maintain effective working relationships with coworkers, managers and clients.