Clinical Trial Oversight Lead

The Clinical Trial Oversight Lead (CTOL) is responsible for the following: Oversight of outsourced monitoring activities to ensure adherence to the protocol, Good Clinical Practice (GCP), evolving regulatory requirements and assess monitoring effectiveness. The CTOL will ensure that the Contract Research Organization (CRO) monitoring is resulting in the effective identification and problem solving of issues.

Conducts oversight visits to assess site performance and CRO effectiveness as directedUtilizes a risk-based approach to review critical to quality items at the site level and study levelFollows Client SOPs and work within Client systems to document oversight activities performedEvaluates clinical trial sites to ensure significant site procedures are performed in accordance with the study protocol, applicable study manuals, GCP, and local regulatory requirementsTroubleshoots and uses alternative and innovative approaches to solve problems impacting clinical site delivery and qualityWorks both independently and collaboratively with cross-functional teamsCommunicates important clinical site assessment information to Clinical teamMay participate in centralized data review/monitoringPartners with Client Clinical Operations and Research staff to become knowledgeable on protocol procedures and requirementsMay assist with study-related training of CRO personnel, particularly Clinical Research Associates (CRAs), and study site team membersPartners with Client and CRO study team members to provide on-site support, answer site questions, and develop custom solutions as neededProvides insight to Client and CRO study team on best practices, e.g., implementation of complex protocol processes and procedures identified at high-performing sitesRemains current with GCP and global regulatory requirements, has a current working knowledge of local/regional regulatory requirementsCompletes assigned training, including general training requirements, Policies, Standard Operating Procedures (SOPs), system, and process-related training

Education and Certification:Bachelor’s Degree is required.A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD) is preferred5+ years of relevant experience with 3+ years of direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/management experience preferred

Skills and Experience:Proven experience in effectively communicating with site staff including Key Opinion Leaders (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 regionGood organizational skills and ability to deal with competing prioritiesEffective communication skills (written, verbal and presentation)Proficient with MS Office Suite (Excel, Word, and PowerPoint)Ability to travel 40-60% of the time

#LI-REMOTE