Site Engagement Senior Director of Clinical Operations
hace 7 días
At Eli Lilly and Company, we unite caring with discovery to make life better for people around the world. Our global healthcare leader is headquartered in Indianapolis, Indiana, where our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
We're seeking a highly skilled Site Engagement Senior Director of Clinical Operations to lead and manage a team of Clinical Research Leads within the country, collaborating with business partners to ensure clinical trials/studies across all therapeutic areas are executed according to scientific objectives, country-specific clinical trial strategy, timelines, budget, and local requirements.
This role is accountable for ensuring consistent high-quality interactions with, and timely robust performance of, global clinical trial sites and vendors. The successful candidate will be responsible for recruitment, training, and development of the team, who are responsible for comprehensive Investigator management, including delivery of Investigator performance metrics, on-time database locks, and inspection readiness.
Clinical Investigator Management:
- Accountable for clinical trial execution within the country of responsibility across all Therapeutic Areas.
- Provide vendor oversight of delegated responsibilities for site monitoring activities of trials within the country.
- Understanding and knowledge of local treatment pathways to support feasibility as required. Input into strategic allocation of trials as required. Create and drive site selection activities.
- Engage externally with all appropriate bodies to understand the country's Clinical Trial regulatory environment and ensure internal processes are maintained to reflect and comply with country requirements.
- Drive real-time mitigation of issues and appropriate problem-solving with a proactive approach.
- Manage Country Business planning and execution.
Organizational Leadership:
- Responsible for development and implementation of applicable risk plans to ensure delivery of clinical trial enrollment commitments and database locks.
- Continuous monitoring of the performance of the Investigator Engagement Team and identification of opportunities for improvement.
- Provide clear direction and align objectives of the Investigator Engagement Team with strategies for clinical development of portfolio assets.
- Enable a culture of continuous improvement focused on outcomes, efficiency gains, and individual accountability.
- Engage in the external clinical development community to influence external improvements and drive the incorporation of external learnings into internal improvement efforts.
- Seek opportunities to identify and apply innovative ideas and/or approaches within the country.
People Management and Development:
- Effectively manage and coordinate an agile organization that continuously adapts to meet the needs of a changing portfolio.
- Manage a diverse organization that fosters inclusion and innovation.
- Coach the Investigator Engagement Team to develop appropriate strategies to ensure positive customer experiences.
- Establish performance plans, monitor, and evaluate the performance of the Investigator Engagement Team.
- Attract, develop, and retain top talent in the Investigator Engagement organization.
Requirements:
- Bachelor's degree or equivalent work experience in a scientific field or health-related field.
- 5 years of experience in Clinical Trials/Development and good working knowledge of Good Clinical Practice.
- Demonstrated leadership skills with the ability to influence, achieve results through others, and lead across the business.
Salary: $120,000 - $180,000 per year, depending on experience
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