Jobs at Fortrea

Lead and develop Clinical Data Management teams, oversee resource planning, quality, productivity, and operational delivery for global clinical trials. Partner with cross-functional stakeholders, drive process improvements, support recruitment and training, ensure regulatory and SOP compliance, and contribute to business development and client-facing activities.

Lead and oversee statistical programming for clinical studies: develop and QC SAS programs to produce SDTM/ADaM datasets and TFLs, create Define-XML/ARM/annotated CRFs, review SAP/TFL shells, mentor junior programmers, interact with clients and QA, and improve programming processes.

Lead and oversee centralized and risk-based monitoring activities across global clinical studies. Identify risks, trends, and safety concerns, drive risk assessments, monitoring plans, analytics, dashboards, and data-driven strategies. Partner with study teams and sponsors, ensure ICH-GCP and regulatory compliance, and support continuous process improvements and sponsor-facing activities.

Support acquisition, review, and integration of external clinical trial data; perform data quality checks; coordinate with internal teams and vendors; contribute to study deliverables and timelines across multiple studies and therapeutic areas.

Lead external vendor data oversight for oncology studies: manage data acquisition, integration, reconciliation, QC/UAT, and query resolution. Serve as liaison between sponsors, vendors, and internal teams, contribute to Vendor Data Plan and edit checks, ensure data integrity and study timelines, and support multiple clinical data projects concurrently.

The Safety Systems Specialist II oversees safety system implementation, configuration, and support, ensuring quality service and collaboration with stakeholders while conducting data analysis and training.

Monitor clinical trial sites including initiation, routine monitoring, and close-out; ensure regulatory compliance and informed consent; perform CRF review, SAE reporting and follow-up; manage site and registry activities; liaise with vendors and clients; support training and local project coordination.

Lead clinical data management from study start-up to database lock, oversee DM deliverables and teams, liaise with sponsors, manage timelines/budgets/scope, mentor staff, ensure GCP/SOP compliance, coordinate cross-functional biometrics activities, support audits, and drive process improvements and client satisfaction.

Lead and conduct on-site clinical trial monitoring for radiopharmaceutical therapy studies, ensuring protocol adherence, patient safety, informed consent, CRF/data integrity, SAE reporting, site management, feasibility, and training. Act as local project coordinator and client contact as assigned, perform monitoring visits, close-outs, and data query resolution using sponsor/CRO data systems.

Lead site monitoring activities for in vitro diagnostic clinical studies including initiation, routine and close-out visits; ensure regulatory compliance, informed consent, data integrity, SAE reporting, CRF review, vendor liaison, registry management, and occasional project coordination. Frequent travel required.

Lead and perform on-site clinical monitoring for oncology CAR-T trials including site initiation, routine and close-out visits, CRF review, SAE reporting, source document verification, vendor liaison, feasibility, registry management, and training/co-monitoring responsibilities.

Perform on-site and remote clinical site monitoring, ensure regulatory compliance and informed consent, review CRFs/EDC data, manage registries, report and follow up SAEs, support site initiation and close-out, train/co-monitor staff, and coordinate local project activities with frequent travel.

Own clinical delivery and operational oversight of trials from site identification through database lock. Manage start-up, regulatory/ethics submissions, budgets, KPIs, vendor performance, monitoring strategy, TMF quality, site payments, recruitment strategies, and cross-functional client communications to ensure compliance, data integrity, patient safety, and inspection-readiness.

The role involves monitoring clinical trial sites, ensuring protocol adherence, reporting serious adverse events, and training new staff, with 5+ years' experience required.

The Sr. CRA 2 will monitor clinical trial sites, manage study compliance, ensure data integrity, and oversee patient safety in oncology studies, requiring strong clinical judgment and teamwork.

The Sr. CRA 2 will monitor clinical trials, manage study sites, ensure regulatory compliance, and assist with training and data integrity verification.

Responsible for monitoring clinical trials, ensuring compliance with protocols, data integrity, site management, and training new employees, with significant oncology experience required.