Jobs at Parexel

Lead global strategy and execution for clinical trial site activation, coordinating cross-functional teams and CROs, managing regulatory and TMF documentation, tracking site/country startup metrics, mitigating risks, and driving process improvements to ensure timely, compliant study launches.

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 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.

Lead enterprise-wide AI adoption by translating technical AI concepts for non-technical stakeholders, curating education and communications, partnering with change management and L&D, triaging requests, and building a team to drive measurable AI adoption across the organization.

Supports coordination and administration of clinical studies from start-up through closeout. Manages local eTMF/ISF, prepares and tracks regulatory and site documents, assists submissions to EC/IRB and regulatory authorities, coordinates meetings, site contracts and payments, and ensures inspection readiness and compliance with ICH-GCP and local regulations.

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.

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

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.

Lead hands-on R and SQL programming for real-world evidence studies using claims and EHR sources (Flatiron, Optum). Clean/validate RWD in Snowflake, implement RWE protocols, apply epidemiologic and statistical methods, create documentation, dashboards, and reporting, and collaborate with study teams to meet timelines.

Lead country-level study startup, execution, vendor oversight, and close activities for low-complexity or portioned studies. Manage country teams, risk mitigation, TMF/ISF oversight, regulatory/EC submissions, recruitment planning, and ensure compliance with ICH-GCP and company standards. Provide local intelligence, drive operational deliverables, and support implementation of eClinical tools and decentralized trial options.

Monitor clinical sites through qualification, initiation, monitoring and close-out visits. Build site relationships, ensure patient safety and regulatory/GCP compliance, verify data quality and drug accountability, manage regulatory documentation, and support recruitment strategies to meet enrollment timelines.

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.

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