Job Description:

The Site and Monitoring Health Lead (SMH Lead) will apply knowledge of regulations and GCPs as well as experience in monitoring to safeguard the quality of clinical trial execution at investigator sites and ensure client’s oversight of CRO monitoring effectiveness. This is a sitefacing position that reports to the FSP Manager, with work directed by the client’s Associate Director (or above), Site and Monitoring Health Team.

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 

• Direct experience managing and overseeing trends in Risk Based Quality Management model / issue management

• 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 

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