Jobs at Parexel

Manages clinical trials from initiation through closeout, overseeing vendors, CROs, monitoring activities, study documentation, site compliance, patient enrollment, investigator meetings, data queries, supplies, contracts, and trial master file maintenance. Ensures adherence to protocols, SOPs, GCP, FDA requirements, and ICH guidelines while coordinating cross-functional stakeholders and resolving execution issues.

Lead and support site start-up through close-out: compile Investigator Initiation Packages, coordinate regulatory and ethics submissions, manage site activation timelines and clinical trial systems, resolve site issues, and collaborate with regulatory and country teams to ensure ICH/GCP and local compliance.

Manages clinical trial investigator sites from activation through close-out, ensuring patient safety, GCP compliance, protocol adherence, data quality, and timely study execution. Responsibilities include onsite and remote monitoring, site relationship management, investigator and staff training, recruitment support, adverse event follow-up, investigational product oversight, issue resolution, CAPA remediation, documentation, audit support, and database release activities. Requires extensive clinical research monitoring experience and frequent travel.

Lead and coordinate clinical trial site activation and operational activities from start-up through close-out. Manage Investigator Initiation Packages, essential documents, regulatory and ethics submissions, site issues, compliance tracking systems, and collaboration with regulatory and supporting teams. Ensure activities meet study timelines, applicable laws, Good Clinical Practice, sponsor standards, and local requirements.

Leads Parexel’s commercial strategy to drive new business growth, market positioning, and high-value bid pursuits. Responsibilities include market and competitive analysis, bid triage, sales messaging, RFI/RFP strategy, client presentations, cross-functional stakeholder alignment, win-loss analysis, industry engagement, and commercial effectiveness initiatives. The role requires executive-level client relationship management, CRO industry expertise, strategic influence, and leadership of global teams.

Lead global site activation for assigned clinical trials, develop and execute site/country start-up strategies, oversee CRO and internal SSU teams, ensure TMF inspection readiness, support regulatory submissions, track metrics and risks, and drive process improvements while collaborating cross-functionally.

Lead country-level study operations from startup through close for one or more clinical trials. Oversee local study teams and CROs, manage startup, site activation, recruitment strategies, vendor oversight, risk and issue mitigation, and ensure timely delivery of study plans and quality event follow-up.

Lead country-level Local Study Teams to deliver clinical study responsibilities (site identification, start-up, monitoring, documentation, budgets, and regulatory submissions) ensuring ICH-GCP and client compliance; support recruitment strategy, risk management, training, audits, and stakeholder communication. Oncology experience required; cell therapy preferred.

Support regulatory pathway planning and agency engagement for vaccines/biologics. Develop pathway recommendations, prepare meeting materials and submissions, identify regulatory risks/opportunities, track timelines, and collaborate cross-functionally to ensure compliance and alignment with development and commercialization objectives.

Lead global clinical trial operations end-to-end: vendor and pCRO oversight, study start-up, monitoring, budgets, risk mitigation, inspection readiness, and delivery of study-level plans and metrics. Mentor study staff, ensure compliance with GCP and SOPs, and coordinate cross-functional teams to achieve recruitment and data quality targets.