Jobs at Parexel

Lead data quality and data management for oncology studies, overseeing DM teams, vendor/CRO management, and compliance with CDISC/ICH-GCP. Develop risk management, integrate and surveil multi-source data, advise stakeholders on data collection and standards, produce metrics and dashboards, manage project resourcing and finances, review contracts, and deliver training to ensure high-quality, regulatory-compliant clinical and real-world data.

The Senior Clinical Research Associate manages clinical trial sites, ensures adherence to regulations, oversees study conduct, and resolves issues while safeguarding patient safety.

Lead and oversee FSP clinical operations and programs, manage line staff and client accounts, ensure on-time/high-quality deliverables, resource projects, manage KPIs, billing and staffing forecasts, resolve escalations and CAPAs, collaborate cross-functionally, support business development and regional client relationships, and drive process improvements and team development.

Lead development and execution of global regulatory plans, align cross-functional teams, manage GRST meetings, anticipate and mitigate risks, drive regulatory submissions (IND/BLA/MAA/eCTD), and deliver strategic reports and dashboards to senior stakeholders to support timely product registration and post-marketing activities.

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.

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.

Lead commercial strategy for site payment services across a global CRO portfolio. Drive pricing, rate cards, bids, and commercial positioning; partner with finance and stakeholders; provide market insights, approve bids, and identify process improvements to increase efficiency and profitability.

The Senior Clinical Research Associate manages site monitoring and relationships for clinical trials, ensuring compliance and patient safety according to GCP and regulations.

Lead and manage midsize-to-large regulatory affairs outsourcing programs, advising clients, driving project delivery and profitability, supporting business development and proposals, mentoring project teams, and staying current with regulatory and industry trends to deliver tailored solutions.

Lead coordination of enterprise data products across Clinical, Corporate, and Commercial domains. Oversee intake, prioritization, governance, and end-to-end delivery across Data Ingestion, Engineering, and Distribution. Build and coach a team of Data Product Coordinators, resolve dependencies, maintain portfolio visibility, and influence stakeholders in a matrixed global environment to deliver data-driven insights for clinical research.

Lead country-level local study teams to deliver clinical study activities (site selection, start-up, monitoring, documentation, regulatory submissions, budgeting, and vendor/stakeholder management) ensuring compliance with ICH-GCP, client SOPs and local regulations. Provide coaching, risk management, reporting, and support audits/inspections while occasionally performing site monitoring and supporting recruitment strategies.

Manage site selection, initiation, monitoring (onsite and remote), and closure for assigned clinical study sites. Ensure compliance with ICH-GCP and sponsor/client standards, maintain study documentation (eTMF/ISF), drive site performance, manage drug accountability, report SAEs, update CTMS, and support audits/inspections and local study team activities.

The Senior Clinical Research Associate is responsible for site management and monitoring of clinical trials, ensuring compliance with regulations and quality standards, and enhancing investigator site relationships.

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 and oversee global clinical study start-up activities and CRO partners to drive site activation, timelines, and compliance. Develop and approve start-up plans, coordinate regional stakeholders, solve operational challenges, and ensure regulatory and GCP adherence across assigned programs.

The Regulatory Affairs Consultant guides clinical studies through regulatory requirements, advising teams on compliance and strategies for efficient trial execution. They engage with health authorities, manage communication, and ensure quality documentation.

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.

Lead clinical data management for assigned studies, ensuring timely deliverables (Go-Live to Database Lock). Coordinate cross-functional stakeholders, manage risks, metrics, contracts, quality/compliance (ICH-GCP), audits, resourcing, and training. Support bid pursuits and represent Data Management to sponsors.

The Senior Clinical Research Associate oversees site management and monitoring for clinical trials, ensuring compliance with GCP, patient safety, and quality execution of studies. Responsibilities include managing operational aspects, training site personnel, addressing protocol issues, and conducting monitoring activities.

Lead global regulatory labeling strategy and governance for pharmaceuticals, managing core labeling documents (CDS, USPI, SmPC), committee leadership, regulatory submissions, health authority negotiations, advertising/artwork review, and cross-functional implementation to ensure compliant, high-quality labeling across international markets.