Provide methodological and statistical support across real-world data projects (EHR, claims, registries). Responsibilities include sample size/power calculations, drafting statistical sections of protocols, developing SAPs, statistical programming for tables/listings/figures, QC of TLFs, and contributing to clinical study reports. Requires 2-4 years' experience, a relevant master's degree, and skills in SAS, R, SQL and/or Python.

Parexel seeks a Senior Regulatory Project Manager to partner with Global Regulatory Leads to shape and execute globally aligned regulatory strategies and plans across development and post‑marketing. Responsibilities include translating strategy into integrated plans, leading execution, facilitating Global Regulatory Subteam (GRST) meetings, managing timelines and risks, and preparing dashboards/reports for senior stakeholders. Requires a BA/BS in a scientific/healthcare discipline (advanced degree or PMP preferred), minimum 7 years industry experience (≥5 years in regulatory or regulatory program management), prior marketing application experience, and experience with eCTD, Veeva RIM, and Smartsheet.

Lead and contribute to global CMC regulatory strategies and post-approval activities for commercial biologics and vaccines, including authoring/reviewing CMC Modules 1-3, dossier gap analyses, and managing lifecycle maintenance (variations, supplements, manufacturing/analytical changes, site transfers). Requires 7+ years' relevant CMC regulatory experience supporting approved biologic and/or vaccine products and knowledge of FDA, EMA, and international regulatory requirements; experience with eCTD/Veeva preferred.

Senior eClinical Business Lead responsible for advising on RTSM/IRT and DHT study design, translating protocol requirements into user requirements and system configurations, assessing integrations and risks, partnering on UAT, and ensuring regulatory and data standard compliance. Role requires 5+ years of relevant experience, strong stakeholder collaboration, and familiarity with CTMS, CDISC SDTM, eCOA/ePRO, and ICH-GCP.

Parexel seeks a Senior Clinical Research Associate / CRA II with minimum 3 years monitoring experience (preferably 2 years in Oncology) to perform on-site and remote monitoring, site activation and close-out, SAE reporting, TMF documentation, protocol training and investigator site management for oncology clinical trials on the US West Coast (remote). Role requires travel within the area, a valid driver’s license and passport.

Manager responsible for leading and mentoring a global team that handles end-to-end site payment management, ensuring timely fund setup and invoice payments, implementing process improvements, and producing regular reporting. Requires minimum 7 years' professional experience (CRO, finance/accounting or comparable) and at least 1 year of management experience; advanced English proficiency expected.

Parexel is hiring a Data Surveillance Analyst to support Data Surveillance Plans and conduct central data reviews using tools such as CluePoints. Responsibilities include creating data import mappings, setting up KRIs and statistical parameters, reviewing project data against Quality Tolerance Limits, documenting findings in issue management systems, and presenting findings to project teams. Requirements: university degree in a relevant field, fluent English, basic SAS experience, familiarity with RBQM and centralized monitoring, basic SDTM knowledge, and proficiency with CTMS/EDMS/MS Office.

Responsible for clinical trial site activation and post-activation document management (IIP, IRB/ethics, FDA 1572, TMF), preparing and submitting regulatory and ethics documents, maintaining clinical systems (CTMS, eTMF, eISF), supporting site audits/inspections, and communicating status to study teams. Requires minimum 2 years relevant clinical site management experience, knowledge of ICH-GCP, and fluency in English.

The role conducts on-site and remote monitoring (qualification, initiation and routine visits), manages site relationships and documentation (TMF, regulatory files), monitors data quality and safety (CRF, queries, SAEs), supports site training and supply/accountability, updates CTMS and other clinical systems, and ensures audit/inspection readiness. Position requires site management or equivalent clinical research experience and a degree or equivalent nursing qualification.

Parexel FSP is hiring an Investigator Contracts Lead II (Spain, remote) to lead direct site-facing contract and budget negotiations, manage the Per-Subject Cost process, handle escalations with pCROs and partners, and oversee other contracting staff on assigned studies. Requires at least 7 years of experience in clinical study budgets and contracting, experience with clinical trial agreements, and fluency in English.

Parexel seeks a Medical Director with an MD and psychiatry residency to provide medical monitoring, lead clinical development activities (phase 1–3) in neuropsychiatric indications, author protocol and regulatory documents, participate on safety and study teams, and interact with senior management. Requires 5+ years in pharmaceutical clinical development and experience in schizophrenia, bipolar disorder, ADHD, and major depressive disorder.

Parexel seeks a Medical Director with an MD and psychiatry residency to provide medical monitoring and clinical leadership for neuropsychiatric indications. Responsibilities include global clinical lead/medical monitor duties, protocol and regulatory document authorship, clinical data and safety review, eligibility review, and cross-functional coordination with clinical operations. Requires extensive psychiatry drug development experience (Phase I-III) in indications such as schizophrenia, bipolar disorder, ADHD, and major depressive disorder and at least 5 years in a pharmaceutical clinical development role.

Lead business analysis for clinical research operations: analyze processes, gather and document requirements, design future-state processes and system solutions (EDC, CTMS, eTMF), support testing and training, and mentor junior analysts. Requires 5+ years of BA experience (minimum 3 years in clinical research), knowledge of regulatory standards (GCP, ICH, FDA, EMA), and experience with tools such as JIRA, Confluence, and Visio.

The Global Study Manager II provides operational leadership and accountability for study management, site management, pCRO and vendor deliverables across a study's lifecycle. Responsibilities include study start-up through database release, vendor and CRO oversight, budget and TMF oversight, inspection readiness, monitoring and enrollment oversight. Requires clinical research/study management experience, knowledge of GCP, and fluency in English.

Responsible for managing the RFP-to-delivery process including proposal and budget preparation, contract drafting and amendments, obtaining third-party quotes, negotiating costs/terms with clients, and maintaining documentation and KPI data. Requires familiarity with clinical study operations, pricing structures, Salesforce and MS Office. Preferably 2 years' related experience and a Bachelor's degree; role is remote within India locations listed.

Vice President, Regulatory Science — Clinical Pharmacology SME role at Parexel offering strategic advisory services to biopharmaceutical clients on clinical pharmacology, PK/PD, pharmacometrics, translational medicine, and regulatory development plans; expected to lead client engagements, advise on dose selection and exposure-response analyses, support regulatory submissions, and represent clients in Health Authority interactions. Role is remote (United States) and includes domestic and international travel.

The role delivers qualitative COA-related research and consulting activities (e.g., qualitative interview studies and analysis) under the direction of project leads and technical SMEs. Requires ~2+ years relevant clinical/consulting experience, proficiency with qualitative analysis software (e.g., Atlas.TI), a bachelor’s in a scientific/technical discipline, strong communication and client-facing skills, and may support project execution, presentations, and business development. Locations listed include the United States, India, and the United Kingdom (remote).

Parexel is recruiting a Regulatory Strategy Senior Associate (remote, Canada) to support regulatory pathway recommendations, agency engagement planning, regulatory submissions and compliance oversight. Requires 4+ years in regulatory affairs or clinical development, experience with vaccines/biologics, FDA regulation knowledge, and familiarity with ICH-GCP and submission tracking systems.

Parexel seeks a General Manager, FSP Operations to lead a large-scale strategic customer relationship, overseeing operational delivery, financial performance, team development, and account growth. Requires 10+ years of leadership in CROs, pharma, biotech or FSP environments, strong financial and stakeholder management skills, and experience with clinical research technologies (CTMS, EDC, EDMS, IWRS/IRT).

Parexel seeks a Regulatory Strategy Consultant (remote, US) to lead regulatory strategy across programs and portfolios, manage authority engagement and high-impact submissions, and contribute to long-range development and lifecycle plans. Requires 10+ years' experience in regulatory affairs or clinical development, experience with vaccines/biologics, and deep knowledge of ICH-GCP, FDA, and international regulatory requirements.