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hace 2 meses
We are seeking a highly skilled Clinical Operations Lead to join our team at Empresa reconocida. As a key member of our operations team, you will be responsible for overseeing the delivery of Site Management project tasks and ensuring overall project efficiency.
Key Responsibilities:- Project Oversight: Provide guidance and advice to achieve high performance and quality project deliverables.
- Project Efficiency: Ensure adherence to project timelines and financial goals; report metrics and out-of-scope activities.
- Site Recruitment and Operations: Develop, implement, and maintain the Site Recruitment, SPS Operations, and SPS Risk Management Plan within the agreed project strategy.
- Collaboration and Communication: Collaborate with other functional groups within the company to support milestone achievement and to manage study issues and obstacles.
- Study Progress Tracking: Manage and follow study activities through ongoing tracking and review of study progress.
- Reporting and Presentations: Provide input and report progress to appropriate SPS management and project management leaders.
- Audit and Compliance: Lead preparation for in-house audits and in creation of Corrective Action Plans (CAPAs).
- Business Development: Participate in business development activities such as proposal development and bid defense.
- Co-Monitoring and Assessment: Conduct co-monitoring and/or assessment visits as needed to ensure the study is being conducted in accordance with the protocol, SOPs, GCP, and applicable regulatory requirements.
- 2-3 years of prior relevant experience as a CPM/CTM in a CRO.
- Previous experience as a CRA lead or Principal CRA in a CRO.
- Skill in understanding and executing complex study designs.
- Strong written and verbal communication skills, including a good command of the English language.
- Demonstrated team leadership and mentoring 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 co-workers, managers, and clients.
