Jobs at Parexel

Develop CMC regulatory strategies and prepare, coordinate, and review GMP-related submissions for biologic, small-molecule, and combination products. Support FDA, EMA, and Health Canada filings from early development through post-approval, provide regulatory guidance to cross-functional teams, address manufacturing and quality issues, and prepare for health authority meetings. Maintain global stakeholder relationships and improve regulatory processes and systems.

Supports sponsors with project management and operational execution for digital pathology in clinical development. Coordinates whole-slide image transfers, vendor follow-up, request tracking, process documentation, compliance activities, and stakeholder communications. The role works cross-functionally with scientific and operational teams to ensure digital pathology workflows are organized and delivered on schedule.

Supports clinical research projects across their lifecycle by maintaining project plans, reports, metrics, budgets, systems, compliance records, and action items. Assists with project initiation, vendor coordination, study supplies, invoice review, meetings, CTMS reporting, and operational closeout. The role collaborates with Project Leaders and Functional Leads to ensure quality, timely delivery, financial oversight, and regulatory compliance across global projects.

Manages investigator sites throughout clinical trials, from activation through database lock and close-out. Conducts onsite and remote monitoring, ensures GCP, regulatory, protocol, and patient-safety compliance, resolves site issues, supports recruitment, reviews adverse events, maintains trial documentation, and contributes to audits and CAPA remediation. Partners with study teams, investigators, vendors, and safety personnel, provides protocol training, and may mentor Clinical Research Associates.

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.

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 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.

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 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.

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.

Lead regulatory strategy across programs and portfolios, advise on authority engagement and submission strategies, coordinate high-impact regulatory submissions, develop lifecycle and long-range development plans, align regulatory approaches with clinical and commercial teams, and monitor regulatory landscape changes to inform development decisions.

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.