Clinical Trial Oversight Lead (FSP)
Parexel International Corporation
Parexel are currently recruiting for a Clinical Trial Oversight Lead.
In this position you will be an invaluable resource to both the sponsor and their CRO partners, you will be responsible for Oversight of outsourced monitoring activities to ensure adherence to the protocol, Good Clinical Practice, evolving regulatory requirements and assess monitoring effectiveness. The CTOL will ensure that the CRO monitoring is resulting in the effective identification and problem solving of issues
Some specifics about this advertised role
Conducts oversight visits to assess site performance and CRO effectiveness as directed Utilizes a risk-based approach to review critical to quality items at the site level and study level Follows Client SOPs and work within Client systems to document oversight activities performed Evaluates clinical trial sites to ensure significant site procedures are performed in accordance with the study protocol, applicable study manuals, GCP, and local regulatory requirements Troubleshoots and uses alternative and innovative approaches to solve problems impacting clinical site delivery and quality Works both independently and collaboratively with cross-functional teams Communicates important clinical site assessment information to Clinical team May participate in centralized data review/monitoring Partners with Client Clinical Operations and Research staff to become knowledgeable on protocol procedures and requirements May assist with study-related training of CRO personnel, particularly Clinical Research Associates (CRAs), and study site team members Partners with Client and CRO study team members to provide on-site support, answer site questions, and develop custom solutions as needed Provides insight to Client and CRO study team on best practices, e.g., implementation of complex protocol processes and procedures identified at high-performing sites
Who are Parexel
Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.
We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.
You’ll be an influential member of the wider team.
What we are looking for in the this role
For every role, we look for professionals who have the determination and courage always to put patient well-being first.
That to us is working with heart.
Here are a few requirements specific to this advertised role.
c5 years of independent monitoring experience, ideally across multiple geographiesProven experience in effectively communicating with site staff including KOLs and thought leadersCritical thinker who can review risk signals and apply to oversight activities at the site levelExperience in all study phases and experience in multiple therapeutic areasPrevious oversight and regulatory inspection experience preferredRisk-based monitoring experience preferredDemonstrates flexibility in schedule and wiling to travel frequently in assigned region
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