Jobs at Parexel

The Regulatory Affairs Consultant guides clinical studies through regulatory requirements, advising teams on compliance and strategies for efficient trial execution. They engage with health authorities, manage communication, and ensure quality documentation.

The Senior Study Contract Manager is responsible for negotiating and managing contracts and budgets for clinical trials, ensuring compliance with guidelines and facilitating communication with stakeholders.

Lead and oversee FSP clinical operations and programs, manage line staff and client accounts, ensure on-time/high-quality deliverables, resource projects, manage KPIs, billing and staffing forecasts, resolve escalations and CAPAs, collaborate cross-functionally, support business development and regional client relationships, and drive process improvements and team development.

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.

The Senior Clinical Research Associate oversees site management and monitoring for clinical trials, ensuring compliance with GCP, patient safety, and quality execution of studies. Responsibilities include managing operational aspects, training site personnel, addressing protocol issues, and conducting monitoring activities.

The Senior Regulatory Consultant will oversee regulatory strategies, manage complex timelines, enhance team performance, and guide regulatory projects to support the development of transformative therapies.

Lead global study start-up and site activation for Phase I-III and real-world studies. Develop and execute start-up plans, partner with CROs and stakeholders, create forecasts and KPIs, remove activation roadblocks, ensure compliance with GCP and local regulations, and mentor junior staff to improve study delivery, timelines, and enrollment.

The Vice President, Project Leadership is responsible for overseeing project delivery, finance management, quality compliance, and strategic resource management while fostering team performance and communication across departments.

Lead data quality and data management for oncology studies, overseeing DM teams, vendor/CRO management, and compliance with CDISC/ICH-GCP. Develop risk management, integrate and surveil multi-source data, advise stakeholders on data collection and standards, produce metrics and dashboards, manage project resourcing and finances, review contracts, and deliver training to ensure high-quality, regulatory-compliant clinical and real-world data.

The Senior Clinical Research Associate manages clinical trial sites, ensures adherence to regulations, oversees study conduct, and resolves issues while safeguarding patient safety.

Lead site selection, initiation, monitoring (remote and onsite), and closure for oncology clinical trial sites. Ensure ICH-GCP compliance, manage site documentation, drug accountability, safety reporting, risk-based monitoring, CTMS/eTMF updates, and support audits/inspections while mentoring junior staff.

Lead country-level Local Study Teams to deliver oncology clinical trials end-to-end. Oversee site identification, qualification, initiation, monitoring, document management (eTMF/ICFs), regulatory submissions, budgeting/agreements, risk management, and vendor/stakeholder coordination. Coach and train CRAs/CSAs, support monitoring activities, ensure CTMS setup, and prepare for audits/inspections while contributing to recruitment strategy and study forecasting.

Negotiate, finalize, and execute clinical trial site contracts and ancillary documents; ensure regulatory (ICH-GCP) and legal compliance; manage contract execution, tracking, archival, and amendments; liaise with sites and internal teams; identify risks and process improvements; mentor junior staff and maintain contract quality and timelines.

Negotiate, draft, finalize, and execute site contracts and related documents for clinical trial site activation and amendments. Ensure compliance with applicable laws, ICH-GCP, and client needs; manage execution, recordkeeping, stakeholder communication, tracking, and process improvements.

Lead commercial strategy for site payment services across a global CRO portfolio. Drive pricing, rate cards, bids, and commercial positioning; partner with finance and stakeholders; provide market insights, approve bids, and identify process improvements to increase efficiency and profitability.

Lead country-level local study teams to deliver clinical study activities (site identification, start-up, monitoring, documentation, regulatory submissions, budgets) ensuring ICH-GCP and client compliance. Support risk management, recruitment strategy, training, audits/inspections, and coordination with global stakeholders. May perform site monitoring as needed.

Lead and manage midsize-to-large regulatory affairs outsourcing programs, advising clients, driving project delivery and profitability, supporting business development and proposals, mentoring project teams, and staying current with regulatory and industry trends to deliver tailored solutions.

The Senior Clinical Research Associate manages site monitoring and relationships for clinical trials, ensuring compliance and patient safety according to GCP and regulations.

Manage site selection, initiation, monitoring (onsite and remote), and closure for assigned clinical study sites. Ensure compliance with ICH-GCP and sponsor/client standards, maintain study documentation (eTMF/ISF), drive site performance, manage drug accountability, report SAEs, update CTMS, and support audits/inspections and local study team activities.

Lead country-level local study teams to deliver clinical study activities (site selection, start-up, monitoring, documentation, regulatory submissions, budgeting, and vendor/stakeholder management) ensuring compliance with ICH-GCP, client SOPs and local regulations. Provide coaching, risk management, reporting, and support audits/inspections while occasionally performing site monitoring and supporting recruitment strategies.