Jobs at Parexel

Leads clinical trial site activation from feasibility through initiation, managing critical paths, regulatory and ethics requirements, documentation, timelines, risks, systems, and cross-functional teams. Serves as a client-facing subject matter expert, guides activation staff, oversees quality and compliance, analyzes metrics, improves processes, and supports proposals and business development across multiple studies and therapeutic areas.

Manages clinical trial sites throughout study phases, serving as the primary site contact and conducting remote and on-site monitoring. Ensures compliance with protocols, ICH-GCP, regulations, and sponsor procedures while protecting participant safety and data quality. Oversees site documentation, recruitment, performance, issue resolution, and audit readiness. Collaborates with internal teams, vendors, investigators, regulators, and ethics committees. Mentors junior CRAs, supports inspections, contributes to process improvements, and travels domestically and internationally approximately 65%–75% of the time.

Lead global clinical trial projects for mid-to-large biotech and pharmaceutical clients. Manage project teams, daily operations, schedules, resources, budgets, and cross-functional coordination while ensuring timely, high-quality delivery and regulatory readiness. The role requires clinical development expertise, strategic problem-solving, strong organization, and client-facing leadership across the full clinical trial process.

Leads clinical data management activities across study startup, conduct, and closeout. Manages delivery timelines, database milestones, data integrations, risks, quality, compliance, audits, resources, and sponsor requirements. Collaborates with global cross-functional teams, supports proposals and financial management, maintains inspection-ready documentation, and provides training and mentorship. Requires extensive clinical data management experience and expertise with Medidata Rave and related clinical trial systems.

Manages end-to-end RFP, proposal, budgeting, and contract processes for clinical research clients. Coordinates subject matter experts and cross-functional teams, leads contract negotiations, establishes account-specific standards, mitigates proposal and contracting risks, facilitates client meetings, and maintains accurate documentation and KPI data. Requires knowledge of clinical trial processes, pricing, cash flow, revenue recognition, and contract management in a regulated environment.

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.

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.