Jobs at Parexel

Conduct site management and monitoring activities from study initiation through closeout for oncology clinical trials. Ensure protocol compliance, data quality, regulatory readiness, site performance, recruitment progress, documentation, study supply accountability, and timely CTMS, EDC, and TMF updates. Build relationships with investigators and site staff, resolve issues, conduct site visits and training, support audits and inspections, and collaborate with study teams while working independently and traveling extensively.

Conduct clinical trial site management from qualification and initiation through closeout. Monitor site compliance, data integrity, recruitment, documentation, safety reporting, study supplies, payments, and regulatory readiness. Perform onsite and remote visits, resolve site issues, maintain CTMS and TMF records, support audits and inspections, and ensure adherence to ICH-GCP and local regulations. Work independently within a matrix team while communicating risks, timelines, and corrective actions.

Lead global CMC regulatory strategy for late-stage and marketed pharmaceutical products. Oversee IND, IMPD, BLA, MAA, and post-approval submissions; manage health authority interactions, manufacturing change assessments, reviewer responses, and regulatory correspondence. Coordinate cross-functional teams across R&D, manufacturing, quality, and clinical development. Provide strategic guidance to senior leadership, manage complex projects, mentor Regulatory CMC staff, and advance innovative regulatory approaches.

Conducts onsite and remote monitoring of clinical trial investigator sites from activation through database lock and closeout. Ensures compliance with protocols, ICH-GCP, regulations, SOPs, and client standards; manages site performance, recruitment, safety reporting, investigational product accountability, data queries, documentation, audits, and CAPA remediation. Partners with study teams, investigators, vendors, and safety teams, supports regulatory inspections, and may mentor CRAs. Requires significant regional travel.

Conduct and oversee clinical trial monitoring across investigator sites from activation through database lock and closeout. Ensure compliance with protocols, ICH-GCP, regulations, SOPs, and monitoring plans; manage site relationships, recruitment, safety reporting, investigational product accountability, data queries, documentation, deviations, CAPAs, audits, and inspections. Collaborate with study teams, vendors, investigators, and safety units, support risk mitigation and database release, and mentor junior CRAs as assigned. The role requires 60–80% regional travel and may include international or weekend travel.

Monitor clinical trial sites from initiation through close-out, ensuring protocol adherence, data integrity, regulatory compliance (ICH-GCP), site training and issue resolution. Conduct on-site and remote visits, update CTMS/TMF/EDC, manage supply/accountability, follow up on CRF queries and SAEs, support recruitment strategies, and maintain audit/inspection readiness while working independently within cross-functional teams.

Provide regulatory consulting and project execution within clinical development projects. Support project planning, client interactions, risk identification, financials, and deliverables. Mentor junior staff, contribute to business development, and ensure team compliance with processes and training. May lead small projects or workstreams and act as main client contact when serving as Project Lead.

The role involves supporting regulatory teams, managing licensing processes, coordinating documentation, maintaining compliance, and engaging in client communications. Project leadership and business development are also key responsibilities.