Jobs at Parexel

Lead site selection, initiation, monitoring (onsite and remote), and close-out activities for oncology clinical trials. Ensure ICH‑GCP, local regulations, and sponsor SOP compliance; manage regulatory submissions, drug accountability, data quality, safety reporting, eTMF/CTMS updates, and readiness for audits/inspections while supporting site performance and risk‑based monitoring.

The Clinical Operations Manager oversees trial protocols, manages budgets, ensures compliance with regulations, coordinates teams, and collaborates with vendors for clinical operations.

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.

The Clinical Research Manager oversees project management and compliance for clinical trials, ensuring adherence to regulations and client policies while leading local teams to high performance.

Support regulatory pathway planning and agency engagement for vaccines/biologics. Develop pathway recommendations, prepare meeting materials and submissions, identify regulatory risks/opportunities, track timelines, and collaborate cross-functionally to ensure compliance and alignment with development and commercialization objectives.

Support Clinical Research Manager across study lifecycle: site and trial administration, document and regulatory management, eTMF reconciliation, CTMS updates, clinical supply and labeling coordination, budgeting/contract negotiation and payments, meeting planning, and adherence to SOPs and GCP.

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

Lead country-level study operations from startup through close for one or more clinical trials. Oversee local study teams and CROs, manage country plans (timelines, budget, risk, quality), drive site activation and recruitment strategies, coordinate regulatory/ethics submissions, resolve site escalations, and ensure vendor deliverables and quality event follow-up.

Lead global clinical trial operations end-to-end: vendor and pCRO oversight, study start-up, monitoring, budgets, risk mitigation, inspection readiness, and delivery of study-level plans and metrics. Mentor study staff, ensure compliance with GCP and SOPs, and coordinate cross-functional teams to achieve recruitment and data quality targets.

Lead country-level study operations from startup through close, overseeing local teams, vendors (pCRO/CTM/SCP), timelines, budgets, risks, and compliance. Provide operational input, manage site activation and recruitment strategies, ensure TMF completeness, support new technologies (eConsent, eISF, remote SDV/SDR, iConnect), and liaise with global stakeholders to resolve escalations and optimize study delivery.

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

Perform clinical data management for Phase I-IV studies: design and test eCRFs/EDC, develop edit checks and DMPs, manage queries, reconcile external data and SAEs, support database lock, and collaborate with cross-functional teams and vendors.