Responsible for managing site activation timelines and documentation, maintaining site relationships, ensuring regulatory and TMF compliance, supporting inspection readiness, and working cross-functionally to address regional challenges for sites in the US and Canada.

The Clinical Laboratory Study Manager supports precision medicine studies by managing biosample process planning (collection, storage, shipping, destruction), vendor selection and oversight, sample tracking and LIMS activities, and coordination with data management/biostatistics for data transfer and reporting. Requires a bachelor's degree (life sciences preferred) and a minimum of 6 years clinical research experience; programming skills (Python/R/Perl/SQL) and regulatory knowledge (ICH/GCP, FDA) are referenced when acting in programming or technical lead capacities.

Parexel is seeking a Contracts Manager to own the contract process for specific accounts, act as primary client contact during negotiations, create and finalize budgets and contractual documents (Start-up Agreements, Work Orders, Change Orders), maintain contractual records, and work closely with Operations, Project Management, Legal and Finance. Role can be home or office based in the UK or Ireland; fluency in English and experience in contract management or proposal development within clinical trials/life sciences is required or preferred.

Parexel seeks a remote CMC Strategy Senior Associate / Consultant to lead and contribute to CMC regulatory strategies, author and review Modules 1-3, perform dossier gap analyses, and support global submissions (US, EU, international) for biologics and vaccines. The role requires collaborative stakeholder management, experience in regulated biopharmaceutical environments, and minimum 3 years' CMC regulatory experience (5+ years for Consultant level). Preference given to candidates able to work Eastern Time hours.

Remote Senior PK Analyst role (based in listed countries) requiring 4+ years' programming experience in R and SAS to derive PK/PD parameters, program and validate NONMEM and derived datasets, and produce tables/listings/figures/statistical appendices. Role involves working to SOP/ICH/GCP standards, mentoring junior analysts, and contributing to process and quality improvements.

Responsible for performance and compliance of assigned country protocols (ICH/GCP), executing and overseeing clinical trial submissions and approvals, managing budgets and contracts, coordinating local vendors/sites and mentoring Clinical Trial Coordinators. Requires bilingual English/French, 5+ years clinical research or combined experience, and the ability to work hybrid (office presence in Montreal/Kirkland ~2 days/week).

Senior Regulatory Affairs Associate (Safety Labelling) to plan, coordinate and deliver global and regional safety labelling activities and regulatory submissions across the product lifecycle. Responsibilities include assessing safety information and submission needs, authoring and maintaining Module 1 and product information (including CCDS/CCSI), managing dossier compilation and submissions, coordinating translations/readability testing, liaising with health authorities and stakeholders, and maintaining RIMS and regulatory records. Requires a scientific degree and fluent English.

Parexel is hiring a Senior Regulatory Affairs Associate (Artwork Coordinator) to manage the progression of approved labelling content into compliant packaging and artwork (PILs, cartons, labels, foils, booklets). Responsibilities include artwork coordination, change-control leadership, translations coordination, documentation and systems use, cross-functional liaison with regulatory, labelling, graphics and operations teams, and mentoring junior staff. Role is home or office based in Croatia, Poland, Hungary, Czech Republic, Romania or Serbia. Fluent English required.

Parexel is hiring a Senior Clinical Research Associate (remote, UK) to oversee sponsor-dedicated oncology study monitoring (remote and on-site). Responsibilities include ensuring ICH-GCP and protocol compliance, source data verification, informed consent review, investigational product accountability, identifying and managing deviations, documenting monitoring findings, and collaborating with site personnel and study teams. Advanced/fluent English and oncology monitoring experience including RECIST are required.

Parexel seeks a Regulatory Affairs Consultant (FSP) with 7+ years' industry experience and deep Australia regulatory expertise. The role owns regulatory strategy, leads high-impact submissions (MAA/CTD/eCTD), manages health authority interactions and lifecycle management, and coordinates cross-functional teams to deliver regulatory outcomes.

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to define and lead global labeling strategy and execution (CCDS, TPL, regional labels, HA responses) across development and post-approval lifecycle. The role requires 7+ years industry experience with significant global labeling leadership, strong medical/technical writing skills, CTD experience, and familiarity with systems such as Veeva RIMS, eDMS, Docubridge, and Trackwise. The position is US-based remote with preference for candidates able to cover EST hours.

Parexel seeks Senior Regulatory Affairs Associates and Regulatory Affairs Consultants to develop and execute U.S. regulatory strategies for vaccine and biologic programs, manage FDA interactions and regulatory submissions (IND, NDA, BLA, sNDA, sBLA), support labeling and post-approval activities, and collaborate with global and cross-functional teams. Required: degree in life sciences/pharmacy and ~5+ years (senior) to 8+ years (consultant) of U.S. regulatory experience with strong knowledge of FDA/CBER requirements.

Parexel seeks Senior Regulatory Affairs Associates and Regulatory Affairs Consultants (remote, Canada) to develop and execute Canadian regulatory strategies, manage Health Canada interactions, prepare and support regulatory submissions (CTAs, NDSs, SNDSs), and handle labelling and post-authorization activities for vaccine and biologic programs. Roles require strong knowledge of Health Canada requirements, regulatory writing, cross-functional collaboration, and relevant industry experience.

Parexel is hiring a Manager, Applications Support to oversee help desk operations and lead a team delivering technical support and customer service for browser-based and client applications. The role includes managing 24x7 shift operations, resolving complex technical issues, driving continuous improvement, using ticketing and knowledge management systems, and collaborating with cross-functional teams. Required: bachelor's/master's degree and 9+ years in help desk or technical support.

Parexel seeks a 0.5 FTE Senior Clinical Research Associate based in Belgium (remote) to monitor oncology clinical trials within a sponsor-dedicated model. Responsibilities include remote and on-site monitoring, source document verification, informed consent checks, investigational product accountability, protocol deviation management, and maintaining inspection-ready site documentation. Requires clinical research monitoring experience in oncology, knowledge of RECIST and ICH-GCP, strong stakeholder and communication skills, and English fluency.

Parexel FSP seeks a Clinical Trial Coordinator to support clinical trial administration, regulatory and site start-up, TMF and document management, clinical supply and labeling coordination, safety reporting, budgeting and contract/payment tracking, and IRB/ethics submissions. Minimum 1–2 years' clinical research or relevant healthcare experience, bachelor's degree or equivalent, bilingual in English and French, strong MS Excel and general IT skills, knowledge of ICH-GCP and good documentation practices. Role is remote in Quebec, Canada with requirement to attend sponsor office in Montreal/Kirkland approximately twice weekly.

Parexel is recruiting an Associate Medical Safety Director to provide medical leadership for oncology product safety across client projects. Responsibilities include signal detection and management, oversight of safety deliverables and aggregate reports (PBRER/PSUR/DSUR), medical monitoring and adverse event review, regulatory interactions and audits, and mentoring colleagues. The role requires a medical degree and substantial oncology and pharmacovigilance experience.

Senior Statistical Programmer responsible for creating SAS programs to produce analysis datasets and tables/listings/figures, performing programming validation, supporting e-submission preparation, and reviewing planning documents. Requires a bachelor's in a quantitative/life science field, proficiency in SAS, several years of clinical/statistical programming experience, and knowledge of CDISC standards (SDTM/ADaM), XML, Pinnacle 21 and eDC.

Parexel is hiring a bilingual (French & English) Clinical Research Associate responsible for conducting QV, SIV, monitoring and close-out visits, ensuring protocol/GCP/SOP compliance, reviewing data quality and drug accountability, developing site recruitment strategies, and maintaining regulatory documentation. Requires 18+ months of direct onsite CRA monitoring experience and a bachelor’s degree or equivalent in biological science, pharmacy or other health-related discipline. Experience with CTMS, EDMS and MS Office is required.

Parexel is hiring a Senior Manager, Global Commercial Operations and Enablement (US remote) to lead sales operations, CRM governance (Salesforce), global sales enablement, campaign execution, and analytics for Inside Sales and MBD teams. Requires 6+ years in sales operations/commercial enablement within CRO, life sciences, or related services; proficiency with Salesforce, sales enablement tools (e.g., Highspot), commercial intelligence platforms, and analytics tools (Power BI/Tableau). Base pay range listed as $120,000–$150,000.