When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Candidates must be located in the Northeast US near a major airport.
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 approximately 50%; may include local, regional, and international travel
Demonstrates flexibility in schedule and willing to travel frequently in assigned region
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 o Proficient in local language, as applicable, preferred o Fluent in multiple languages and cultural awareness preferred
Knowledge and Experience:
Significant direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies
Previous CRO monitoring oversight experience and experience with oversight visits required
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 up to 50%; some international travel may be required
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.