Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
In order to deliver data of highest quality and integrity as an industry leading, patient centric CRO, Clinical Operations are seeking a highly experienced and visionary Global Monitoring Strategist to join our Clinical Operations Senior Leadership team. The successful candidate will be responsible for owning and driving evolution of our monitoring processes, acting as an industry thought leader, and leading the strategy for the incorporation of new technologies into our monitoring practices. This role is critical in ensuring the highest standards of clinical trial monitoring and compliance, while driving innovation and efficiency.
Key Responsibilities:
Monitoring Process Ownership:
- Develop, implement, and continuously improve global monitoring processes and standards.
- Ensure compliance with regulatory requirements, industry best practices, and company policies.
- Oversee the execution of monitoring activities to ensure high-quality data collection and patient safety.
- Ensure evolution in CRG system infrastructure continuously improve quality in monitoring to deliver high quality data with optimal integrity
Industry Leadership and Thought Leadership:
- Act as a thought leader in the field of clinical trial monitoring, representing the company at industry conferences, webinars, and other forums.
- Publish articles, white papers, and other thought leadership content to establish the company as a leader in clinical monitoring.
- Collaborate with industry stakeholders and conference community to influence and shape the future of clinical trial monitoring.
Strategic Planning and Evolution:
- Lead the development and execution of the global monitoring strategy, aligning with overall company goals and objectives.
- Identify and evaluate emerging trends, technologies, and methodologies in clinical trial monitoring.
- Drive the evolution of monitoring practices to enhance efficiency, quality, and patient safety.
Technology Integration:
- Take a lead business role in the assessment, selection, and implementation of new technologies and tools to enhance monitoring processes.
- Collaborate with our technology experts and cross-functional teams to integrate new technologies into existing systems and workflows.
- Ensure that new technologies are effectively adopted and utilized by monitoring teams.
Collaboration and Communication:
- Work closely with project therapeutic business units and commercial teams to ensure the monitoring strategy is communicated with simplicity and clarity.
- Ensure that customers understand the monitoring strategy and that project teams can execute it effectively.
- Partner with customer facing leaders in dialogue about monitoring evolution and model design
- Facilitate regular communication and updates to stakeholders on the progress and impact of monitoring strategies.
Team Leadership and Development:
- Provide leadership, guidance, and mentorship to monitoring teams globally in partnership with Operational leadership to enable consistency and quality in monitoring.
- Act as expert in proposal process where monitoring strategy expertise is required to support competitive and effective monitoring strategy.
- Foster a culture of continuous improvement, innovation, and excellence within the monitoring function.
- Contribute as expert to training programs to enhance the skills and capabilities of monitoring staff.
Qualifications:
- Bachelor's degree in life sciences, clinical research, or a related field.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 15+ years).
- 8+ years of management responsibilities
- Extensive experience in clinical trial monitoring, with a proven track record of leadership and innovation.
- In-depth knowledge of global regulatory requirements and industry best practices for clinical trial monitoring.
- Strong strategic, critical thinking, ability to confidently network across the enterprise and proven problem-solving skills.
- Excellent communication and presentation skills, with the ability to influence, motivate and inspire others.
- Experience with the implementation and integration of new technologies in clinical trial monitoring.
- Proven ability to collaborate with cross-functional teams and communicate complex strategies clearly.
- Ability to travel globally as required.
