Clinical Operations Director
hace 2 semanas
Job Summary
We are seeking a highly experienced 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
- Oversee the delivery of site management project tasks, providing guidance and advice 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 to support milestone achievement and 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.
- Lead preparation for in-house audits and create corrective action plans (CAPAs).
- Develop and deliver presentations/training to clients, colleagues, and professional bodies.
- Participate in business development activities such as proposal development and bid defense.
- 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.
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 coworkers, managers, and clients.
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