Clinical Research Associate
Parexel is hiring a Clinical Research Associate to support clinical development work, including activities related to clinical trials, regulatory, consulting, and market access.
Designing insights-driven clinical trials. Delivering trusted solutions. Accelerating life-changing medicines. As a leading global clinical research organization (CRO), we bring our diverse perspectives together to tackle each challenge with determination, excellence, and compassion, knowing there's no limit to what we can accomplish.
When you join Parexel, you become part of a team where collaboration is real, respect is fundamental, and empathy is woven into our fabric. Through it all, at the center of everything we do, is a patient whose life could change – forever. Our unique emphasis on the patient experience drives us forward, helping treatments reach those who need them most. And together, we'll do it With Heart™.
Benefits vary by country, but Parexel is passionate about our team’s overall wellness. Our Flexible Work Program offers the choice to work from where you want and how to accommodate personal responsibilities and interests outside of work. Our Recognition Program allows colleagues and managers to acknowledge teamwork, helping each other, and helping change the lives of patients. It is our priority to put people first so we can fulfill our mission and accomplish our best work.
We believe that investing in your professional and personal development is an investment in Parexel, and we want to help you realize your full potential and career. In order to ensure the highest quality of work for our clients and our patients’ safety, Parexel takes a targeted and balanced approach to support both the immediate training needs and the long-term development investment in our employees.
Parexel is hiring a Clinical Research Associate to support clinical development work, including activities related to clinical trials, regulatory, consulting, and market access.
Parexel seeks a senior regulatory affairs clinical consultant based in Japan (fully remote) to lead development regulatory strategy, manage PMDA advice/consultations, prepare and review J‑NDA/CTD dossiers (including eCTD), coordinate cross-functional teams (medical writing, translation, eCTD), and manage project timelines and client communication. Requires experience in NDA/CTD/eCTD preparation, PMDA interactions (support-level acceptable), or relevant clinical/non-clinical/CRO medical writing experience. Japanese and English business-level communication is required.
Under project leadership, support clients on CMC-related regulatory strategy for clinical development and marketing authorization in Japan, prepare submission dossiers (new applications, variations, minor changes), create PMDA consultation materials, respond to regulatory queries, assist MF/FMA procedures, GMP assessments, Cartagena Act filings, and perform change-management regulatory evaluations. Requires 3+ years CMC regulatory experience in pharma or CRO, university degree in pharmacy or natural sciences, and English business communication (TOEIC ~700).
Lead the implementation and integration of Microsoft Copilot and Azure AI services across enterprise applications. Build low-code solutions using Microsoft Power Platform (Power Apps, Power Automate, Power BI, Power Pages, Power Query) and integrate with SharePoint and Microsoft 365 to improve productivity and automate workflows. Requires 6+ years' software development experience and hands-on Power Platform experience.
Parexel is recruiting for its 2026 China campus talent pool (CDA/SP/PSA). The opportunity relates to clinical development functions including clinical trials, regulatory, consulting and market access. Positions are listed for China with Beijing/remote location mentioned. Parexel emphasizes improving global health and contributing to therapy development.
Parexel is hiring a Payment Specialist. The role is based in Beijing, China (remote). Parexel provides clinical development services including clinical trials, regulatory, consulting, and market access.
Parexel is hiring a Clinical Research Associate II (FSP) to support clinical development solutions including clinical trials, regulatory, consulting, and market access. The role is listed as China — Guangzhou (remote).
Senior Clinical Project Manager (FSP) role at Parexel. Location listed as Shanghai, China with remote indicated. Parexel provides clinical trial, regulatory, consulting, and market access services.
The Scientific Specialist develops, writes, edits, and quality-controls scientific content for medical communications projects. The role requires interpreting scientific data, applying therapy-area knowledge and industry guidelines (e.g., Good Publications Practice), managing project tasks and client interactions, and mentoring/peer-reviewing work of colleagues and freelancers.
Provide project coordination support to account teams for medical communications and publications projects: track timelines and deliverables, manage publications/MedEd tracking (Datavision, iEnvision, PubStrat), organize meetings and congress submissions, maintain documentation and dashboards, monitor budgets and risks, liaise with clients and faculty, and support proposal/budget/pitch development. Bachelor’s degree preferred.
Parexel is hiring a Biostatistician II to coordinate and lead statistical activities for clinical trials, including analysis plans, randomizations, statistical reports, QC of datasets/tables/listings, and support for DMC reviews. Role requires SAS programming experience and advanced statistical knowledge; PhD or MS in statistics (with corresponding experience) is specified. The position includes client interaction, occasional travel to meetings, and contribution to business development and study design.
Cross-check scientific information against cited references and ensure reference integrity; review/add anchor links and citation style; ensure alignment with latest local approved product label and flag off-label statements; QC essential information (ISI, brand/generic names, AE reporting), footnotes, terminology, branding, style, format, grammar, spelling and punctuation; create documentation and checklists for Asset Technical and MLR Review based on local guidelines.
Parexel is hiring a Study Manager (FSP). The company provides clinical development solutions including clinical trials, regulatory, consulting, and market access. Role locations listed as Beijing and Shanghai with remote work.
Parexel seeks a Clinical Project Manager (FSP) for work based in China (Beijing/Shanghai, remote). The role relates to clinical trials and clinical development and references regulatory, consulting, and market access activities. Employer: Parexel.
Parexel seeks a Senior Associate with a Master's/PhD and at least 3 years' experience in pharma, consultancy, HTA/access, or academia. The role involves designing evidence-generation plans, conducting statistical analyses (e.g., GLMs, survival analysis, NMA, Bayesian methods), developing technical documentation and economic models, and contributing to cross-functional Access/HTA strategies. Proficiency in R and GitLab is required; familiarity with SAS, Python, WinBUGS, or JAGS is a plus.
The role delivers application support and high-level production support including ticket resolution, system integrations, and on-call duties. It requires writing and delivering quality code for testing and validation, documenting issues and solutions, performing unit testing, and mentoring junior staff. Minimum qualifications include a bachelor’s degree in IT/Computer Science (or related) and 2–4 years of IT support experience; skills listed include SQL and Java.
Responsible for authoring global CMC variation submissions, annual reports, renewals, post-approval roll-outs and responses to health authority queries. Requires proven CMC regulatory writing and submission-management experience for biological products and vaccines (M3 authoring mandatory), strong stakeholder management, and at least 5 years' industry experience.
Senior CRA responsible for site activation, routine and close-out monitoring (on-site and remote), investigator engagement and training, AE/SAE handling, TMF and study documentation, enrollment support, data query resolution, investigational product oversight, and audit/CAPA activities. Requires minimum 3 years of site monitoring experience and substantial travel (60–80%) within the assigned area; bachelor’s degree in life sciences or equivalent required.
The Site Monitor II performs on-site and predominantly virtual monitoring per the Study Monitoring Plan, ensures protocol and regulatory compliance, manages site documentation in CTMS/EDC/TMF, follows up on CRF queries/SAEs, supports site training and readiness for inspections. Requires minimum 3 years' clinical monitoring experience and English proficiency.
Implements and monitors clinical trials (on-site and remotely), assesses and initiates investigative sites, performs SDV and source file reconciliation, reviews IP accountability and SAE reporting, updates trial tracking systems, facilitates audits, and mentors junior CRAs. Duties include communicating with sites, escalating and resolving site/trial issues, and supporting protocol amendments and site budget negotiations as needed.