Site and Monitoring Health Lead

Key Responsibilities:

• Implement client’s Site and Monitoring Health strategy in alignment with ICH GCP E6 and E8

• Employ risk-based thinking to focus on what is critical to quality, and exhibit an “inspection ready at all times” mentality

• Create Study Specific Oversight Plans (SSOP) for aligned trials in scope and/or follow SSOP when conducting oversight activities

• Implement various types of oversight encounters and activities as applicable including but not limited to: site risk analysis, site contacts, aggregate review of data, monitoring visit report review, Sponsor Oversight Visits, system/data spot checks, and periodic summaries; ensure timely documentation of these activities is completed and filed

• Build relationships with investigators and site staff in region; act as a resource for identifying potential sites for new studies

• Utilize root cause analysis to assess identified issues and provide suggested actions to Study Management / CRO to mitigate risk

• Support investigator sites less experienced in research; assist in assuring sites are engaged in the study and have what they need to recruit participants successfully

• Troubleshoot and use alternative and innovative approaches to solve problems impacting clinical site delivery and quality

• Work closely with Clinical Risk & Analytics staff to understand the risk management plan (Risk MAP) for assigned studies, ensure the SSOP is aligned with the Risk MAP, and assess sites who are outliers

• Lead oversight and trend meetings with the study team and/or CRO to discuss risks, issues, and trends identified by the SMH team for the trial

• Complete Sponsor Oversight Visit reports consistently on time and with good quality

• Work independently and collaboratively with cross-functional teams

• Support inspection preparation and management

• Maintain awareness of changes in industry and regulatory standards for GCP requirements

• Travel on assignment ~ 50% is required. This is a site facing position and travel may fluctuate up or down depending on business need. May include local, regional and international travel.

Requirements

• Bachelor's Degree is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred

• Previous direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/management experience preferred

• Experience in all study phases of clinical research (Phase I-III) and experience in both prevalent and rare medical conditions preferred

• Previous audit and regulatory inspection experience preferred

• Comprehensive and current regulatory knowledge, including GCPs

Skills

• Demonstrate flexibility in schedule and willingness to travel frequently in assigned region

 • Excellent interpersonal, verbal, and written communication skills

• Fluency in multiple languages and cultural awareness is a plus

• Ability to build and maintain relationships with key investigators and sites (e.g. key networks, key trial sites and investigators, key opinion leaders and their site staff

• Innovator, willing to initiate changes, introduce new ideas, and creatively problem-solve

• Experience with Microsoft based applications and ability to learn internal and external computer systems

• Good organizational skills and ability to deal with competing priorities

• Analyze complex situations and effectively communicate issues along with potential recommendations to various functional groups

• Demonstrate good judgment and decision-making experience