Lead Clinical Operations Strategist
4 settimane fa
Unlock Your Potential as a Senior Clinical Operations Leader
The Senior Clinical Operations Leader plays a pivotal role in orchestrating the efforts of functional team members across diverse regions. This position serves as a crucial link between project leadership and sponsors, ensuring that Clinical Operations deliverables—such as timelines, quality, and productivity—are consistently achieved. The individual in this role holds comprehensive accountability for the implementation of the clinical operations strategy throughout the project lifecycle.
This role may also encompass responsibilities as a Project Leader for smaller projects that do not have an assigned Project Leader. The Senior Clinical Operations Leader is tasked with coordinating clinical teams for small to midsize projects, serving as a mentor and role model for team members, and may also contribute to a global project management team.
- Facilitate effective communication with both internal and external stakeholders, including third-party vendors.
- Prioritize tasks efficiently and respond promptly to urgent requests from team members or sponsors.
- Oversee study start-up activities and contribute to project planning tools.
- Provide insights for sponsor reports and site selection strategies.
- Develop comprehensive site selection and monitoring plans.
- Review and enhance patient recruitment and retention strategies.
- Foster strong working relationships with functional leaders and coordinators across various geographies.
- Design study plans, tools, and forms that meet project needs.
- Guide and direct project team members effectively.
- Assess resource requirements and monitor resource utilization throughout the project lifecycle.
- Set productivity targets for project team members.
- Identify potential issues early and contribute to contingency planning.
- Track study timelines, patient recruitment, retention, and data integrity to ensure project success.
- Maintain high-quality standards for all work produced and escalate issues as necessary.
- Implement process improvements within the project framework.
- Contribute to revenue recognition forecasts and identify scope changes.
- Conduct site visits as required by project demands.
- Engage in client, investigator, and team meetings.
- Prepare for and participate in audits and inspections.
- Collaborate with project teams on database lock activities.
- Ensure completion of administrative closeout procedures alongside the Project Leader.
- Participate in end-of-study meetings, providing valuable feedback and insights.
- Maintain compliance with ICH-GCP Guidelines, local regulations, and company SOPs.
- Complete routine administrative tasks efficiently.
- Possess substantial experience in clinical research, including leadership roles in clinical functions.
- Hold a degree in life sciences, nursing, or equivalent experience.
- Demonstrate strong written and oral communication skills in English.
- Exhibit leadership qualities and a strong customer focus.
- Effectively manage multiple tasks with attention to detail and enthusiasm.
- Display excellent interpersonal and presentation skills.
- Willingness to travel as needed.
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