Jobs at Parexel

Coordinates clinical-study sourcing for depots, investigational medicinal products, couriers, medical devices, and ancillary supplies. Responsibilities include supplier research and evaluation, quotations, purchase requests, contracting, import/export documentation, returns, quality issue resolution, risk mitigation, sourcing ticket management, and supply planning. The role advises internal stakeholders, analyzes sourcing data, supports compliant procurement, manages supplier relationships, and mentors junior team members in a remote, fast-paced clinical research environment.

Supports global pharmaceutical labeling operations, including regulatory-compliant document development, artwork and change-management coordination, regulatory tracking, regional implementation, version control, SOP maintenance, and stakeholder training. The role ensures labeling governance and compliance across the product lifecycle while collaborating with regulatory, operations, artwork, and regional teams.

Manages global clinical trial operations from protocol design through study closeout, including CRO and vendor oversight, regulatory tracking, recruitment, budgets, timelines, risk mitigation, trial documentation, training, and stakeholder coordination. Supports inspection readiness, process improvement, team onboarding, and operational strategy across Phase I-IV studies.

Provides CMC regulatory strategy and post-approval support for biologics and plasma products. Develops submission plans, assesses manufacturing and quality changes, reviews technical documentation, coordinates global regulatory submissions, manages regulatory information systems, and mitigates compliance risks. Requires pharmaceutical regulatory affairs experience, biologics CMC expertise, and knowledge of global post-approval requirements.

Provides operational and administrative support for clinical trials from study start-up through closeout. Responsibilities include maintaining tracking systems and study files, coordinating training and meetings, managing sample and supply tracking, supporting vendors and study teams, performing document quality checks, archiving in the TMF, and assisting with budget tracking. Requires knowledge of clinical operations, ICH-GCP, eTMF systems, and essential trial documents.

Leads end-to-end global clinical trial delivery across Phases 1–4, overseeing cross-functional teams, CRO vendors, budgets, timelines, quality, compliance, risk mitigation, inspections, and operational milestones. The role also supports governance, process improvement, mentoring, and stakeholder coordination across clinical development functions. Approximately 10% travel is required.

Monitors and manages clinical trial sites from qualification through closeout, ensuring protocol, GCP, regulatory, data, safety, documentation, and investigational product compliance. Conducts site visits, trains investigators, reviews source data and essential documents, tracks action items, maintains CTMS records, supports audits and study teams, and collaborates with sites and functional groups. Requires substantial travel and Phase I monitoring experience.

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.

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.