Sr. Clinical Operations Lead

ResponsibilitiesOversee clinical operations of a project at a regional/global level in accordance with the Monitoring Plan, Protocol, GCP, ICH guidelines, and local regulations. Act as primary liaison between Clinical Research Associates (CRAs) and the clinical project team. Provide project‑specific training of CRAs, conduct assessment visits, and support enrollment and recruitment strategies. Develop study tools for sites and CRAs, review visit reports, track protocol deviations, and support the clinical project team. Prepare monitoring plans and oversee monitoring visit scheduling, site performance metrics, issue escalation, and corrective actions. Perform review of visit reports for quality, compliance, and appropriate site management. Proactively manage site and country performance (recruitment, data collection, document collection, TMF review, etc.) and inform the clinical project team on progress. Contribute to financial project management processes, including revenue recognition, site payments, and site pass‑through expense review (as applicable). Project OversightOverall oversight of regional CRAs to ensure site compliance with the study protocol, study plans, ICH‑GCP, local regulations, and study timelines. Support monitoring visits (Co‑monitoring) per project requirements to aid site/CRA compliance and performance. Assist the clinical project team by overseeing study deliverables related to other departments (e.G., Data Management, TMF Operations). Oversee regional startup and feasibility activities. Assist in vendor management activities as required per project. Ensure compliance with high quality and timely project deliverables according to the monitoring plan. Manage site and country performance metrics and inform the clinical project team on progress. Provide oversight of investigator sites, including CRA responsibilities, on a temporary or permanent basis (if required). Project LiaisonConduct regular global CRA calls with the monitoring and site management team, and individual/country CRA calls. Attend meetings with Study Sponsor to provide status updates on country and site progress. Provide operational support and guidance to the monitoring team throughout the project. Provide project training/mentoring to regional CRAs on study procedures, clinical plans, and guidelines; ensure study‑specific training requirements are completed and documented. Act as first point of contact for regional CRAs for study‑specific questions and issues; escalate to PM and other functions as appropriate. Support line managers by providing status updates on utilization and performance of CRAs. Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project. Conduct CRA assessment visits per departmental requirements to assess CRA performance. Study Documents and PlansDevelop training materials and study tools for sites and CRAs, including monitoring plans. Develop and implement enrollment and recruitment strategies together with the clinical project team. Develop presentation materials for and present at Sponsor Kick‑off meetings, Investigator meetings, and Sponsor Calls (as needed); prepare presentations for Site Qualification Visits and Site Initiation Visits. QualificationsCollege diploma/degree AND 7‑9 years related experience + continuous training and knowledge/skills upgrading. orUndergraduate university degree (Bachelors or Honors Bachelors) AND 4‑6 years’ experience + substantial job‑related training. Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation. Minimum of 3 years CRA experience, strong experience with EDC systems, proficiency with MS Office, strong written and verbal communication, and highly effective interpersonal and organizational skills. Demonstrated attributes: proactive, detail‑oriented, task‑driven, and highly organized. Demonstrate critical elements of GCP and local regulations as they relate to clinical monitoring and Investigator responsibilities. Strong ability to write reports and critically understand clinical research documents. Ability to handle multiple tasks to meet deadlines in a dynamic environment. Working ConditionsHome‑based. Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to #J-18808-Ljbffr