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Rwe Clinical Operations Lead
hace 1 día
**Clinical Operations Lead**
**Essential Functions**:
- Oversee the delivery of Site Management project tasks, providing advice and guidance to achieve high performance and quality project deliverables.
- Ensure overall project efficiency and adherence to project timelines and financial goals; report metrics and out of scope activities.
- Develop, implement and maintain the Site Recruitment, SPS Operations and SPS Risk Management Plan within the agreed project strategy.
- 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 on assigned projects.
- Lead preparation for in-house audits and in creation of Corrective Action Plans (CAPAs).
- Develop and deliver presentations/training to clients, colleagues and professional bodies, as required.
**Requirements**:
- Bachelor Degree preferably in a life sciences discipline, and 4 years of monitoring experience, team leadership experience; or equivalent combination of education, training and experience.
- Previous experience as Clinical Trial Manager
- 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.
- Strong written and verbal communication skills including good command of English language.
- Demonstrated team leadership and mentoring skills.
