Regional Monitoring Lead

Duration: 12 Months+

This position will be responsible for collaborating closely with internal Clinical Operations, Data Management, and key external stakeholders to deliver high quality data across the entire portfolio. This position will develop, lead, and oversee consistent planning and execution of core clinical operations activities (e.g., site networking, feasibility and selection, monitoring/monitoring oversight strategy, site performance and inspection readiness) for North America in collaboration with the study team.

Essential Duties & Responsibilities:

• Develop country specific strategy to drive efficient study start up activities, with a key focus on fostering direct relationships with investigator sites to facilitate study conduct.
• Oversee resource and talent management of regional monitors, whether insourced or via outsourced suppliers, to maintain quality of monitoring that will deliver and achieve Clinical Operations study team goals. Responsible for identifying CRA performance issues and corrective actions.
• Partner with key internal stakeholders, (Clinical Operations, Legal) to develop integrated business processes and systems to drive standardized, efficient study start-up cycle times globally.
• Partner with Clinical Operations and other key stakeholders in developing a fit for purpose monitoring and monitoring oversight strategy. Drive and/or oversee monitoring oversight activities at the study-specific, program and portfolio levels to ensure quality of data, site compliance with ICH GCP and study requirements, and monitoring performance.
• Ensure the quality and compliance of studies, by cultivating an environment of process excellence within the Regional Monitoring organization.
• Contribute to development of standard processes and tools in line with country regulations, ICH GCP, and industry standards with a focus on study start up, monitoring, and monitoring oversight standard processes and tools to ensure consistency in Sponsor oversight throughout study conduct.
• Responsible for tracking and oversight of site feasibility, study start-up, monitoring and site management related KPIs and metrics in collaboration with the assigned Clinical Operations study team to ensure risk identification and mitigation and continued improvement to drive quality data and compliance.
• Be the point of escalation for issues that arise in site engagement, escalating as necessary and keeping the relevant Clinical Operations study team informed of escalation and resolution. Effectively solve problems and use judgment relating to national and international regulations, guidelines, investigator interactions and timelines.
• Partner with Clinical Operations and Clinical QA, and key internal/external stakeholders to support sponsor and/or health authority site audits/inspections. Contribute to CAPA development and implementation.
• Manage functional budget, including resource projections and capacity assessment, to ensure adequate and appropriate regional monitoring resourcing for clinical studies and programs.

Education And/or Experience:

• Minimum of 8 years’ experience in the pharmaceutical industry and/or clinical research organization with at least 5 years’ experience monitoring clinical trials. Years of experience will determine job description level (sr. manager vs. assoc. director vs. director).
• University degree (equal to 4 years of college) in (para-) medical, pharmaceutical, sciences, life-sciences or biosciences.
• Prior experience in ophthalmology preferred.
• Previous experience in line management of employees, contractors, and vendors in a remote working environment preferred.
• In-depth and current knowledge of clinical research, including FDA and international regulations, ICH-GCPs, clinical study design and documentation, and conduct of clinical trials.
• Experience developing processes, tools and training related to sponsor oversight activities.
• Strong experience in establishing effective relationships with investigator sites.
• Ability and willingness to travel as required domestically and internationally up to 25-30%.

Supervisory Responsibilities: Yes

Other Skills & Abilities:

• Excellent verbal and written communication skills.
• Excellent interpersonal skills; ability to interface with other functions within the company.
• Ability to work independently, analyze and work with attention to detail, process and prioritize complex information, and problem solve.
• Ability to collaborative effectively in a dynamic, cross-functional matrix environment
• Strong strategic thinking, planning, execution, and communication skills

Shift: Day