Parexel is hiring Project Leader and Senior Project Leader roles (home-based, US) in its Biotech Division to lead global clinical trial teams. Responsibilities include leading project teams, managing day-to-day operations, project scheduling, resource and budget management, coordinating team activities, and supporting the full clinical development process through regulatory submissions. Therapeutic experience sought includes neurology, oncology/hematology, respiratory, cardiology, general medicine and GLP-1/obesity.

Parexel is recruiting a Country Study Operations Manager I to lead country-level study activities (start-up through close) for trials with limited complexity or portions of larger studies. The role includes oversight of pCROs/CTMs/SCPs, site activation and recruitment planning, TMF/ISF oversight, regulatory and ethics submissions support, vendor management, quality and audit readiness, and implementation of decentralised trial tools (eConsent, eISF, remote SDV/SDR). Candidates must be based in Brazil, Mexico or Argentina, have experience with US/Canada, be fluent in English, and have the minimum relevant clinical trial operational experience stated in the posting.

Full-scope Start-up Associate role focused on site activation and maintenance for clinical trials: act as primary contact for assigned sites, conduct site qualification and readiness activities, prepare and submit IRB/IEC and MoH/RA packages, manage TMF/CTMS/eTMF records to First Time Quality, and ensure sites are audit-ready and compliant with ICH-GCP. Degree-level education in a health-related discipline or equivalent nursing qualification is preferred.

Parexel is hiring a Clinical Research Associate (I/II/Senior) to manage site selection and start-up, perform remote and onsite monitoring (SDR/SDV/CRF review), maintain regulatory documentation (EC/IRB submissions, eTMF, ISF), ensure ICH-GCP compliance and SAE reporting, and support risk-based quality management. Requires proficiency in English, fluency in local language(s), a relevant bachelor’s degree, and ability to travel nationally/internationally as required.

Parexel seeks a Clinical Operations Assistant to support Clinical Research Associates and project teams across Latin America. Responsibilities include tracking, scanning, filing and returning Case Report Forms, managing documents in the electronic document management system, site payments, site supplies, and trial master file related tasks, with limited contact with investigator sites. Role is fully home based in Brazil, Mexico, or Colombia; fluency in English, MS Office skills, study site experience, and a university degree in healthcare or science are required.

Provides regulatory support including preparation/co-ordination of local documentation (Module 1), management of post-authorization activities (variations, renewals, PSURs), health authority interactions, impact assessments and support for HA inspections. Works within project teams, may lead small projects or work streams, participates in consulting and business development activities. Requires more than 3 years industry experience in Australia (including New Zealand experience) and a Bachelor’s degree in a scientific/technical discipline; extensive working knowledge of English.

Parexel FSP is hiring Site Care Partners in Argentina (Buenos Aires/remote). The SCP I is the primary client contact for investigative sites and is accountable for site start-up through activation, ongoing site support, recruitment/enrollment delivery, quality and patient safety, and issue resolution. Role expects approximately 5+ years' experience (Senior CRA background), requires English proficiency, and involves travel up to 75%.

Parexel’s FSP seeks Clinical Research Associate II and Senior CRA I/II for remote roles covering Mexico, Brazil and Argentina. Responsibilities include virtual and on-site monitoring in line with the Study Monitoring Plan, ensuring data integrity, data quality, protocol and ICH GCP compliance, site management and close-out. Minimum experience: CRA 1 year, Senior CRA 3 years, Senior CRA II 5 years. Degree or equivalent nursing/health qualification preferred. English is required.

Parexel seeks Senior Clinical Research Associates for FSP activities supporting site activation, monitoring (onsite and remote), close-out, AE/SAE management, TMF documentation, and resolution of protocol/site issues. Minimum 3 years monitoring experience required; oncology experience preferred. Significant travel (60–80%) within the area; candidates must be fluent in English and the local language.

Role requires ~4-6 years' experience handling lifecycle management of approved small molecules and biologics (including vaccines and monoclonal antibodies). Responsibilities include authoring and reviewing CMC components of MAAs and variations (EU DCP/MRP/National), responding to health authority queries, preparing annual reports/renewals, GMP/site registrations, conducting regulatory impact assessments, maintaining submission plans, and using RIMS such as Veeva Vault. Familiarity with EU labeling (QRD) and excipients is expected.

Acts as the principal labeling strategist within Global Regulatory Affairs, driving development and maintenance of dCCDS/CCDS, USPI and SmPC, providing labeling input to clinical development and Therapeutic Area teams, and leading Global Labeling Committee assessments. Requires a university degree in life sciences and a minimum of 10 years' biotech/pharmaceutical industry experience (including 6 years labeling/regulatory); fluency in English.

Parexel is hiring a Labelling Strategy Regulatory Affairs Consultant to lead maintenance and alignment of the Company Core Data Sheet (CCDS), USPI and EU SmPC for assigned products; lead Global Labeling Committee assessments and manage exceptions between CCDS and regional labels; liaise with clinical, safety, regulatory and commercial stakeholders. Requires a life sciences degree, minimum 7 years industry experience including at least 4 years in labeling/regulatory roles, and fluency in English.

Senior CRA accountable for site activation, monitoring, issue resolution and close-out of investigator sites to ensure patient safety and trial quality per GCP and sponsor standards. Requires minimum 3 years' site monitoring experience (preferably 2 years in oncology), a life sciences degree or equivalent, fluency in English, and ability to travel 60–80% (valid driver’s license and passport required).

As a Regulatory Affairs Consultant (Regulatory Intelligence), you will monitor, analyze, and translate local, regional, and global regulatory changes into actionable insights for global and local regulatory teams. The role involves impact assessments, preparing briefings/newsletters, external engagement with regulators and industry forums, and collaboration with functions such as Quality, Pharmacovigilance, and Medical Affairs. The position can be fully home based or office based and requires fluency in English.

Parexel seeks Clinical Research Associates to monitor clinical trial sites via on-site and remote visits, build relationships with investigators, manage site-level study documentation and visit reports, collaborate with cross-functional teams, implement corrective actions, and ensure sites remain audit- and inspection-ready. Role is home-based with eligibility limited to candidates residing in São Paulo, Rio de Janeiro, Curitiba, or Porto Alegre. Requires a bachelor’s degree in life sciences/pharmacy/nursing or related field, fluent English and Portuguese, minimum 1 year CRA experience, ability to travel, and a valid driver’s license.

Implements and monitors clinical trials at investigative sites (on-site or remotely), assesses site qualification, verifies clinical data and SAE reporting, and ensures IP accountability. Maintains trial documentation and tracking systems, facilitates audits, mentors junior CRAs, and supports related clinical operations tasks such as protocol amendments and site budget negotiation.

Provide medical monitoring and act as the medical representative on project teams for oncology clinical trials, including review of adverse events, safety and lab data, AE coding, preparation of regulatory reports and clinical documents, and presentation at meetings. Requires MD, board certification/fellowship in oncology (or equivalent), at least 2 years' adult oncology experience, prior medical monitoring/industry physician/PI experience preferred, and willingness to travel up to 10%.

Parexel seeks a Senior Regulatory Intelligence Associate to monitor, analyze, and translate local, regional, and global regulatory developments for biological products. The role involves impact assessments, preparing briefings and recommendations for global and local regulatory teams, external engagement (conferences, forums, meetings with authorities), and cross‑functional collaboration to inform regulatory strategy. Location is Mexico (remote); fluency in English and Spanish is required.

Parexel is hiring a Clinical Research Associate II (fully decentralised in the UK). The role conducts qualification, initiation, monitoring and termination visits; manages site relationships and recruitment strategies; reviews data quality, drug accountability and regulatory documentation; and ensures compliance with protocol, SOPs, GCP and applicable regulations. Requires site management/clinical research experience, ability to perform monitoring independently, a relevant degree and strong communication and computer (CTMS/EDMS/MS Office) skills.

Parexel seeks Project Leader and Senior Project Leader candidates to lead global biotech clinical trial projects (Neurology/Psychiatry/Rare Disease). Responsibilities include leading project teams, managing day-to-day operations, scheduling, resources, budgets, team coordination, and supporting the full clinical development process through regulatory submissions. Minimum 2+ years' experience leading global clinical trials in a PM role; advanced degree preferred.