Jobs at Parexel

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

Accountable for planning, coordination, and conduct of clinical trial activities per ICH-GCP. Manage trial documentation, systems, supplies, submissions, TMF, and reporting. Support cross-functional and regional teams, ensure regulatory compliance, monitor trial progress, implement corrective actions, and contribute to quality oversight and process improvements.

Lead and support site start-up and activation for assigned studies: compile Investigator Initiation Packages, coordinate regulatory and ethics submissions, update clinical trial systems, manage cross-functional activities, resolve site issues, and ensure compliance with GCP, sponsor standards, and study timelines.

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 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.

Lead and deliver regional site start-up and activation activities for clinical trials, ensuring regulatory compliance, timely site activation, CTMS/TMF documentation, stakeholder coordination, inspection readiness, and process improvements. Act as primary site contact and regional escalation point to resolve activation barriers and meet study timelines.

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.

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.