Jobs at Parexel

Manage clinical trial sites from qualification and initiation through closeout. Responsibilities include monitoring on-site and remotely, ensuring protocol, ICH-GCP, regulatory, and data-integrity compliance, resolving site issues, reviewing documentation, supporting recruitment, managing study supplies and payments, following up on CRFs, queries, and SAEs, maintaining CTMS and TMF records, and ensuring audit readiness. The role requires independent problem-solving, collaboration with investigators and study teams, client interaction, and extensive travel.

Leads clinical study start-up, pre-SIV, activation, and protocol amendment activities from site identification through activation and maintenance. Manages regulatory submissions, site documents, timelines, readiness, training, risks, and audit preparedness. Coordinates with investigators, site staff, IRBs/IECs, health ministries, regulatory authorities, sponsors, and cross-functional teams while maintaining compliant, high-quality records in CTMS, eTMF, and TMF systems.

Conducts on-site and remote monitoring of oncology clinical trial sites, ensuring protocol, ICH-GCP, regulatory, data quality, and patient safety compliance. Reviews source documents, medical records, consent documentation, CRF data, investigational product accountability, site logs, and protocol deviations. Resolves queries, tracks action items, documents monitoring activities, supports inspection readiness, and collaborates with investigators, site staff, Site Managers, and project teams to meet trial timelines.

Lead statistical programming activities for clinical trials, including producing and quality-checking SDTM and ADaM datasets, tables, figures, listings, specifications, and regulatory documentation using R. Coordinate global programming teams, timelines, budgets, resources, quality control, and sponsor interactions. Review analysis plans and database specifications, provide technical consultation and training, support audits and inspections, and ensure compliance with SOPs, ICH-GCP, CDISC, 21 CFR Part 11, and other regulatory requirements.

Supports clinical trial site activation, maintenance, and closeout. Responsibilities include coordinating system access, training, document and equipment shipments, Trial Master File management, site issue follow-up, payment administration, CTMS and study tracker updates, inspection readiness, database lock support, and administrative compliance activities. The role requires strong organization, communication, computer, problem-solving, and prioritization skills, with knowledge of clinical research processes and applicable ICH-GCP and regulatory requirements.

Conducts clinical trial site monitoring and management from selection through closeout. Performs source data verification, ensures data quality and timely submission, identifies and resolves site issues, supports patient safety and regulatory compliance, trains site staff, maintains trial documentation and monitoring logs, prepares reports, and ensures adherence to ICH-GCP, local regulations, client procedures, and study protocols.

Lead and manage FSP Data Management programs and teams, ensuring on-time, high-quality deliverables. Oversee resourcing, staffing, performance management, client governance, KPI compliance, issue escalation/CAPA, budgeting/billing tracking, and cross-functional collaboration. Support business development, process improvements, and regional client relationships while fostering staff development and retention.

Conduct site monitoring and management for clinical trials, including source data verification, data quality oversight, issue resolution, patient safety compliance, investigator site training, reporting, and study documentation. Maintain Site Master Files, Trial Master Files, monitoring logs, and clinical trial registry information while ensuring compliance with ICH-GCP, local regulations, and client procedures. Collaborate with investigators, healthcare professionals, CTAs, and cross-functional teams.

Supports clinical trial initiation, maintenance, and closeout activities, including site activation, staff access and training, document and TMF management, site issue follow-up, payments, CTMS updates, equipment returns, and database lock support. Ensures compliance with ICH-GCP, regulatory requirements, SOPs, timelines, and study procedures while coordinating with clinical teams, sites, vendors, and sponsors.

Supports clinical research activities at Parexel, contributing to clinical trials and the development of therapies intended to improve patient health. The provided description emphasizes Parexel’s clinical development work, regulatory services, consulting, market access, empathy, and commitment to patient outcomes.

Leads FSP data management programs within a CRO, overseeing financial performance, resource planning, client relationships, regulatory compliance, service quality, delivery metrics, process harmonization, and cross-functional team development. The role also develops scalable FSP strategies and solutions, supports business growth, manages stakeholder relationships, and identifies margin improvement and service expansion opportunities across therapeutic areas.

Develops sponsor-specific rate cards and FSP pricing models, leads margin and cost analyses, and supports commercial negotiations and proposal development. Partners with Business Development, Finance, Contracts, and Operations teams to recommend pricing strategies. Maintains pricing tools and repositories, improves workflows and reporting, uses Power BI and automation tools for decision-making, and ensures accuracy, consistency, and compliance across pricing deliverables. This is a fully home-based role in Argentina supporting global stakeholders.

Supports computational biology and bioinformatics activities for clinical development studies. Responsibilities include updating figures and analyses, executing automated pipelines, performing data and results QC, building RMarkdown, Quarto, and Shiny viewers, integrating cross-study datasets, preparing Olink randomization layouts, and maintaining reusable AI-assisted coding resources. The role requires programming, version control, statistical fundamentals, validation discipline, and experience processing molecular or clinical trial data in life sciences settings.

Analyze and visualize biomarker and high-dimensional proteomic data for clinical research. Responsibilities include running and optimizing automated pipelines, quality control, data integration, identifier harmonization, interactive viewer development using R Shiny, experiment preparation, documentation, and results delivery. The role also supports AI-assisted code development and establishes reusable bioinformatics workflows while following regulated processes and collaborating cross-functionally.

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.

Provides regulatory consulting and project execution support for clinical development engagements. Responsibilities include managing project activities, client relationships, timelines, risks, training compliance, financial forecasting, reporting, scope changes, and closeout. The role also contributes to consulting deliverables, presentations, business development, proposals, and internal compliance activities while maintaining scientific and regulatory industry knowledge.

Provides Level 3 escalation support for complex desktop, operating system, productivity application, hardware, and user profile issues. Performs root-cause analysis, develops permanent fixes and documentation, supports Microsoft Intune and Azure Virtual Desktop environments, maintains standardized endpoint configurations, assists with software distribution, and identifies process improvements. Collaborates with users, support teams, engineering, infrastructure, and application groups while delivering clear customer-focused communication.

Conducts onsite and remote monitoring of clinical trial investigator sites from activation through database lock and closeout. Ensures compliance with protocols, ICH-GCP, regulations, study plans, and client standards; manages site issues, deviations, safety reporting, investigational product accountability, data queries, recruitment support, documentation, and CAPA activities. Partners with study teams, investigators, vendors, and safety units, supports audits and inspections, and may mentor CRAs. Requires significant regional travel.

Manage assigned clinical trial sites from initiation through closeout. Conduct on-site and remote visits, assess protocol compliance, resolve site issues, review data quality and documentation, support recruitment, manage study supplies, and ensure audit readiness. Maintain CTMS, EDC, TMF, and related systems while complying with ICH-GCP, regulations, sponsor requirements, and Parexel procedures. Collaborate with investigators, site staff, study teams, and administrative support while independently managing priorities and escalating risks.

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.