Jobs at Parexel

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.

Manage the full lifecycle of purchase orders in SAP, reconcile POs, run spending and actuals reports, support invoice processing and accruals, liaise with scientists, Finance, and Procurement, address ARIBA queries, support audits and year-end PO maintenance, and maintain PO documentation.

Lead a global organization delivering investigator payment services across regions and portfolios. Set strategy, drive operational excellence, modernization (automation, analytics, AI), stakeholder engagement, and talent development to ensure timely, accurate, compliant site payments and scalable processes.

Lead planning, execution, and delivery of oncology/inflammation clinical trials. Oversee trial setup, conduct, vendor management, regulatory compliance, patient/site engagement, risk mitigation, data cleaning, TMF archiving, and cross-functional coordination to meet milestones and KPIs.

Provide end-to-end regulatory affairs support for partnered pharmaceutical programs, including document and archive management, clinical regulatory support (e.g., Form FDA 1572 waivers, GLP reviews), drafting administrative submission components, building electronic submission structures, authoring and reviewing regulatory submissions, and managing post-approval reporting and compliance. Serve as regulatory liaison in alliance and cross-functional meetings to track deliverables and ensure regulatory readiness.

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 multi-channel recruitment marketing campaigns to build talent pipelines and reduce time-to-hire. Create employer brand content, analyze ATS and recruitment data for insights and SEO, manage vendor relationships, coordinate hiring events, and collaborate with cross-functional teams to optimize the candidate journey.

Lead and manage FSP Data Management program(s), overseeing staff, resourcing, client relationships, KPIs, budgeting/billing, compliance, and continuous improvement to meet contractual deliverables and retain talent.

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.

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.

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.

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.

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.

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.