Jobs at Parexel

Provides direct nursing care to participants in early-phase clinical trials. Responsibilities include administering investigational treatments, monitoring participant health, assessing eligibility and symptoms, coordinating laboratory testing, collecting and processing samples, documenting findings, entering clinical data, supporting participant enrollment, and ensuring compliance with SOPs, GCP, and study protocols. The role requires an active California RN license, BLS certification, and ACLS certification within six months of starting.

Onsite bilingual (English/Mandarin) research associate supporting Phase I clinical trials: recruit and screen participants, conduct protocol visits, maintain study logs and supplies, handle samples, assist physicians and monitors, ensure participant safety and data quality, and follow clinical operating and quality management guidelines.

Manages investigator sites throughout clinical trials, from activation through close-out, ensuring patient safety, GCP compliance, protocol adherence, recruitment progress, data quality, investigational product accountability, and timely documentation. Conducts onsite and remote monitoring, resolves site and data issues, supports audits and CAPA activities, addresses adverse event reporting, trains site personnel, and collaborates with study teams, investigators, vendors, and drug safety partners. Requires substantial travel and expertise in clinical research regulations and monitoring.

Manages investigator sites throughout clinical trials, from activation through close-out. Responsibilities include onsite and remote monitoring, ensuring GCP and regulatory compliance, supporting recruitment and enrollment, addressing protocol issues and data queries, monitoring adverse events, overseeing investigational products, maintaining study documentation, resolving site issues, and supporting audits, CAPA, and database release. Requires collaboration with investigators, site staff, study teams, vendors, and drug safety personnel.

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

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 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.

Develops strategic, differentiated proposals and contracts for CRO business development, particularly FSP and FSO models. Responsibilities include researching markets and therapeutic areas, identifying client needs, coordinating cross-functional stakeholders, managing proposal timelines, maintaining templates, creating case studies and thought leadership content, and mentoring junior team members. Requires strong proposal or contract management experience, clinical research and contractual knowledge, excellent writing and communication skills, global collaboration experience, and proficiency with Microsoft Office, design tools, and database systems.

Leads clinical data management for assigned studies, overseeing data delivery timelines, database milestones, cross-functional collaboration, risk mitigation, study metrics, quality compliance, audits, resources, and financial variances. Supports proposals, sponsor presentations, training, corrective actions, and organizational initiatives. Requires extensive clinical data management experience, knowledge of ICH-GCP and clinical data standards, strong leadership and communication skills, and proficiency with clinical data management systems.

Leads Parexel’s commercial strategy to drive new business growth, market positioning, and high-value bid pursuits. Responsibilities include market and competitive analysis, bid triage, sales messaging, RFI/RFP strategy, client presentations, cross-functional stakeholder alignment, win-loss analysis, industry engagement, and commercial effectiveness initiatives. The role requires executive-level client relationship management, CRO industry expertise, strategic influence, and leadership of global teams.

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.

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 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.

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 global regulatory labeling strategy and governance for pharmaceutical products across US, EU, and international markets. Responsibilities include managing core labeling documents, regulatory submissions, artwork, health authority negotiations, compliance reviews, committee leadership, change control, and lifecycle implementation. The role requires cross-functional collaboration, interpretation of clinical and scientific data, regulatory expertise, and proficiency with labeling, document management, and change management systems.

Conducts oncology clinical trial site management, monitoring, activation, routine visits, and close-out activities. Ensures compliance with protocols, ICH/GCP, FDA regulations, sponsor standards, and patient-safety requirements. Manages investigator relationships, recruitment, adverse-event follow-up, investigational product accountability, data queries, documentation, protocol deviations, and CAPA remediation. Partners with study teams, vendors, and site personnel, supports audits and inspections, and may mentor Clinical Research Associates.

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.

Serve as a Clinical Pharmacology subject-matter expert advising biopharma sponsors on regulatory strategy, clinical pharmacology plans, dose selection, PK/PD and pediatric/special population strategies; lead client engagements and regulatory interactions; assess IND/CTA/NDA/BLA/MAA submissions; present at conferences, publish, mentor internally, and provide thought leadership across therapeutic areas.