Jobs at Parexel

Leads oncology solution strategy for Parexel’s clinical research business, partnering with enterprise accounts and strategic business units to develop competitive proposals, risk assessments, operational strategies, and client solutions. Provides oncology expertise across pre- and post-sales activities, supports bid pursuits and discovery sessions, communicates with senior stakeholders, identifies market opportunities, and informs product development. The role requires global clinical research experience, strategic drug development planning, and up to 30% travel.

Supports clinical scientists and study teams in the scientific and operational conduct of clinical trials. Responsibilities include adjudication support, medical monitoring, imaging data reconciliation, meeting materials, protocol deviation management, stakeholder coordination, and compliance with ICH-GCP and company procedures. Oncology experience is required, while pharmaceutical experience and two years of medical monitoring experience are preferred. The role requires advanced Excel skills, strong communication, English proficiency, and willingness to travel for key meetings.

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.

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.

Conducts qualification, initiation, monitoring, and termination visits for metabolic, MASH, and obesity clinical trials. Manages sites from identification through closeout, maintains site relationships, supports recruitment, resolves issues, verifies regulatory documentation, evaluates data quality and investigational product accountability, and ensures compliance with protocols, Good Clinical Practice, and applicable regulations.

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.

Conducts oncology clinical trial site monitoring from qualification through closeout, including initiation, monitoring, and termination visits. Manages site relationships, evaluates data quality and investigational product accountability, supports patient recruitment, resolves site issues, and ensures compliance with protocols, Good Clinical Practice, SOPs, and regulatory requirements. Serves as the primary contact for clinical sites while protecting participant safety and study integrity.

Conducts ophthalmology clinical trial monitoring from site qualification through closeout. Manages site relationships, performs onsite visits, verifies regulatory documentation and clinical data, supports patient enrollment, resolves site issues, and ensures compliance with protocols, Good Clinical Practice, regulatory requirements, and study procedures. Evaluates site performance, investigational product accountability, participant safety, and data quality while collaborating with investigators, site staff, clients, and internal teams.

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.

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.

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.

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.