Clinical Site and Monitoring Health Lead - US - FSP

Job Purpose:

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 the client’s oversight of CRO monitoring effectiveness. This is a site-facing position that reports to the FSP Manager, with work directed by the client Associate Director (or above), Site and Monitoring Health Team.

Key Accountabilities:

Oversight of monitoring effectiveness

• Implements 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 file

• Completes Sponsor Oversite Visit reports consistently on time and with good quality

• Utilizes a risk-based approach to review critical to quality items at the site level and study level, exhibiting an “inspection ready at all times” mentality

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

• Troubleshoots and uses alternative and innovative approaches to solve problems impacting clinical site delivery and quality

• Utilizes root cause analysis to assess identified issues and provide suggested actions to Study Management/Clinical Research Organization (CRO) to mitigate risk

• Supports inspection preparation and management

Collaborative relationships

• Works both independently and collaboratively with cross-functional teams

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

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

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

Operational

• Implements client Site and Monitoring Health strategy in alignment with applicable International Council for Harmonization-Good Clinical Practices (ICH-GCP) regulations

• Leads oversight and trend meetings with the study team and/or Clinical Research Organization (CRO) to discuss risks, issues, and trends identified by the SMH team for the trial

• Remains current with global regulatory requirements, has a current working knowledge of local/regional regulatory requirements

Skills:

• Ability to think innovatively and be willing to initiate changes, introduce new ideas, and creatively problem-solve

• 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 stie staff)

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

• Demonstrates good judgment and decision-making experience

• Ability to travel; moderate, may include local or regional

• Good organizational skills and ability to deal with competing priorities

• Effective interpersonal verbal, written and presentation communication skills Proficient with MS Office Suite (Excel, Word, and PowerPoint); able to learn internal and external computer systems

• Proficient in written and spoken English required

Knowledge and Experience:

• Significant direct CRA / monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies

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

• Lead CRA experience required

• Experience in all study phases of clinical research (Phase I-III)

• Previous audit and regulatory inspection experience preferred

• Ability to travel; moderate travel

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