Jobs at Parexel

The Investigator Contracts Lead manages contract and budget negotiations for clinical investigator sites, overseeing contract execution and resolving related issues during studies.

Design and code R and SQL programs to clean, validate, and analyze real-world data (Optum, Flatiron). Implement RWE protocols using epidemiological and advanced statistical methods, document analyses for reproducibility, create dashboards/reports, review programming plans, and collaborate with study teams to meet timelines and reporting requirements.

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.

Responsible for site selection, initiation, monitoring (on-site and remote), and closure of clinical trial sites; ensure compliance with ICH-GCP, local regulations and sponsor/Company SOPs; manage site training, study drug accountability, data quality (SDR/SDV), safety reporting, CTMS/eTMF documentation, and escalate issues. Support audits/inspections and contribute to local study team activities to drive site performance and recruitment.

Manage site selection, initiation, monitoring (remote and onsite), and closure for assigned clinical study sites. Ensure ICH-GCP and sponsor compliance, maintain study documentation (eTMF, ISF), perform SDV/SDR/CRF review, manage drug accountability, support audits/inspections, update CTMS, resolve queries, and drive site performance while collaborating with local study teams and stakeholders.

Lead country-level Local Study Teams to manage site selection, start-up, monitoring, regulatory submissions, document management (eTMF/MICF), budgeting/agreements, risk management, and reporting to global study leads. Ensure compliance with ICH-GCP and local regulations, coach team members, support audits/inspections, and contribute to recruitment and study timelines.

Lead country-level Local Study Team(s) to deliver clinical study activities (site selection, start-up, monitoring, documentation, regulatory submissions, budgeting) in compliance with ICH-GCP, client SOPs and local regulations. Oversee CTMS/eTMF setup, manage risks, support recruitment strategy, coordinate audits/inspections, and provide coaching and reporting to global stakeholders.