Jobs at Parexel

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 Site Activation Partner coordinates activities and documentation for clinical trial sites, ensuring compliance with timelines and regulations, and resolving site issues.

This role involves leading CMC regulatory strategies for global product lifecycle activities, authoring documentation, and managing submissions across international markets.

Lead and manage country-level local study teams to deliver oncology clinical trials in Canada, overseeing site selection, start-up, monitoring, regulatory submissions, document management (eTMF/MICF), budgeting, risk management, vendor coordination, and stakeholder communication. Support training, audits/inspections, recruitment strategy, and ensure compliance with ICH-GCP and local regulations.

Lead site delivery for oncology clinical studies including site initiation, monitoring (onsite and remote), regulatory submissions, data and safety oversight, CTMS/eTMF documentation, risk-based monitoring, issue escalation, and preparation for audits/inspections while mentoring junior staff.

The Site Activation Partner I leads and supports operational activities for clinical trials, ensuring compliance with timelines and regulations while managing site activation tasks.

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.

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.

The Manager, Project Planner coordinates project schedules, manages resources, and ensures timely deliverables by collaborating with cross-functional teams in clinical and commercial settings.

The Senior CRA ensures quality site management and monitoring of clinical trials, addressing protocol-related issues while maintaining compliance and investigator relations.

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.

The Study Start Up Project Manager leads global start up strategy, coordinating with various teams to activate study sites and ensure compliance, quality, and timely completion of clinical trial start up activities across multiple therapeutic areas.

The Start Up Project Manager II leads global project strategies for clinical studies, managing site activations and coordinating with cross-functional teams to ensure timely and efficient project delivery across various therapeutic areas.

The Clinical Study Administrator coordinates clinical study activities, ensuring document compliance, supporting submissions, managing communications, and maintaining study tracking systems.

The role involves managing clinical trial budgets and contracts, negotiating with stakeholders, and ensuring compliance with regulations. Responsibilities include budget development, contract negotiations, and cross-functional collaboration to optimize clinical research support.

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

The Investigator Contracts Lead focuses on negotiating and managing clinical trial agreements, ensuring compliance, and collaborating with various stakeholders to facilitate site contracting processes.