Clinical Operations Lead
- 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 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.
- Demonstrate knowledge and experience working in start-up functional area.
- Manage virtual teams and coordinate start-up processes to achieve SSU completion within the required timelines.
- Collaborates with the Site Management Team to provide centralized site support, communication and coordination, to assure accurate and timely completion of all contracted 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.
- Lead preparation for in-house audits and in creation of Corrective Action Plans (CAPAs).
- 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.
- Mentors less experienced Clinical Operational Leads.
- 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.
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