Jobs at Parexel

Provides senior-level statistical programming expertise for clinical trials using SAS. Leads programming teams, produces and quality-controls SDTM and ADaM datasets, tables, figures, listings, and submission documentation. Coordinates timelines, budgets, resources, sponsors, and cross-functional stakeholders while ensuring compliance with SOPs, ICH-GCP, CDISC, 21 CFR Part 11, and regulatory standards. Also mentors staff, supports audits and inspections, and contributes to process improvement and technical consulting.

Supports clinical research activities at Parexel, contributing to clinical trials and the development of therapies intended to improve patient health. The provided description emphasizes Parexel’s clinical development work, regulatory services, consulting, market access, empathy, and commitment to patient outcomes.

Conduct clinical trial site qualification, initiation, monitoring, and termination visits. Build site relationships, resolve issues, protect patient safety, support recruitment, ensure protocol and regulatory compliance, evaluate data quality and drug accountability, and verify regulatory documentation. Requires Finnish fluency, conversational Swedish, clinical research or site management experience, and a relevant degree or equivalent nursing qualification.

Conducts on-site and remote monitoring of oncology clinical trial sites, builds investigator and site relationships, manages study documentation and visit reports, collaborates with cross-functional teams, implements corrective actions, and ensures audit and inspection readiness. This home-based role supports clinical trial quality and compliance across study phases and requires English and Spanish fluency, travel, and a relevant bachelor’s degree.

Manages Early Phase Risk and Compliance Leads supporting clinical units and trials. Oversees risk identification, scoring, mitigation, regulatory compliance, inspection readiness, audits, quality agreements, and quality-system improvements. Partners with Quality Assurance, clients, and senior leadership while managing, mentoring, and developing staff. Requires extensive clinical research experience, people-management experience, ICH-GxP expertise, and strong communication and project-management skills. Hybrid role with travel up to 10%.

Provide project-level support to Project Lead and team across project phases. Set up project tools per SOPs, produce reports and analyses, highlight issues, and collate monthly project financial metrics.

Leads APAC market business development across Japan, China, and South Korea. Manages and develops a geographically dispersed team, establishes regional growth strategies, analyzes pipeline and performance metrics, standardizes processes, and partners with marketing, sales, and business units. Supports strategic opportunities, customer engagement, conferences, and complex commercial initiatives. Requires life sciences or healthcare industry experience, business development or sales leadership expertise, and strong stakeholder management skills.

Oversee local clinical trial delivery from site identification through closeout, leading CRAs and CSAs, coordinating monitoring, regulatory submissions, budgets, risk management, essential documents, and investigator relationships. Ensure compliance with ICH-GCP and local regulations, support patient recruitment, resolve study issues, and perform site monitoring as needed. Requires clinical research experience, team leadership, project management, regulatory knowledge, and a life sciences degree.

Leads early-phase clinical trials and programs, managing sponsor relationships, study start-up, site selection, contracts, budgets, vendors, risks, compliance, financial activities, and project closeout. Oversees project teams and PM Assistants while ensuring operational excellence, timely delivery, quality standards, regulatory compliance, and effective communication throughout the clinical research lifecycle.

Provide strategic regulatory affairs support for Germany and Austria across mRNA therapeutics and vaccines. Responsibilities include regulatory strategy, compliance operations, product information and artwork management, promotional review, market access support, authority interactions, project leadership, regulatory training, and process innovation using Generative AI. The role requires deep German, Austrian, and European pharmaceutical regulatory expertise, fluent German and English, and at least weekly on-site presence in Munich.

Conduct and oversee clinical trial monitoring activities from site activation through database lock. Manage investigator-site relationships, ensure compliance with protocols, GCP, regulations, and monitoring plans, resolve site and data issues, monitor adverse events, support recruitment and database release, and maintain required documentation. The role also involves audit and CAPA support, investigator training, risk mitigation, cross-functional collaboration, and significant travel.

Designs and delivers global pharmacovigilance solutions, supporting pre-sales proposals, budgets, commercial development, post-award account management, client relationships, and delivery oversight. The role requires strong stakeholder and consulting skills, process improvement expertise, and the use of automation to improve safety-service quality, efficiency, and scalability. This individual contributor partners with cross-functional teams throughout the client lifecycle, from proposal development through operational execution and account management.

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.

Lead and support site start-up through close-out: compile Investigator Initiation Packages, coordinate regulatory and ethics submissions, manage site activation timelines and clinical trial systems, resolve site issues, and collaborate with regulatory and country teams to ensure ICH/GCP and local compliance.

Supports clinical research activities at Parexel, contributing to clinical trials and the development of therapies that improve patient health. The description emphasizes collaboration, empathy, and commitment to clinical development outcomes.

Analyzes clinical and operational data to support risk-based quality management and data surveillance. Develops surveillance plans, configures monitoring technologies, evaluates trends and outliers, identifies data quality issues, documents findings, and supports project reviews, meetings, audits, and regulatory inspections. The role requires programming in SAS, R, or SQL, data analysis expertise, familiarity with centralized monitoring and SDTM, and strong communication skills.

Supports regulatory operations and submission execution for pharmaceutical products in Hong Kong and Macau. Responsibilities include preparing and tracking clinical trial applications, import permits, marketing applications, variations, and renewals; coordinating with internal teams, partners, and Health Authorities; maintaining regulatory records; supporting inspections and audits; developing local procedures; and monitoring regulatory updates.

Leads enterprise data engineering strategy and global teams responsible for real-world data movement, lakehouse architecture, ingestion, transformation, storage, optimization, governance, security, and standardized data products. Partners with technology, analytics, and business stakeholders across clinical, safety, financial, and corporate domains. Oversees delivery prioritization, roadmaps, quality, reliability, team development, and scalable cloud data solutions using Azure Databricks, SQL, Python, and CI/CD.

Leads the design and implementation of clinical data management solutions, including vendor data transfers, ingestion, reconciliation, validation, reporting, and data quality controls. Ensures compliance with ICH-GCP, 21 CFR Part 11, SOPs, and regulatory standards. Coordinates technical teams, manages project timelines and scope, mentors staff, develops documentation and standards, and contributes technical expertise to business development activities.

Analyzes clinical and operational data to support data surveillance, risk-based quality management, and quality tolerance limit reviews. Develops surveillance plans, configures monitoring technologies, creates KRIs and statistical parameters, identifies trends and data quality signals, documents findings, and escalates study issues. Collaborates with clinical, technology, and project teams, supports monitoring meetings and audits, and ensures compliance with ICH-GCP, regulations, and company procedures.