Parexel

Research Analyst

• Oversight of Monitoring Responsibilities and Study Conduct
• Ensuring regulatory, ICH-GCP and protocol compliance.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject as required.
• Manages reporting of protocol deviations and appropriate follow up.
• Documents activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP.

Senior Clinical Research Associate – Oncology

Operations

• Support Payment / Procurement and Finance Processes
• QC Reagents and Materials Procurement & Logistics Support
• Vendor Management and Information Maintenance
• Contract Management
• Manage Systems / Accounts and Access Management
• Support Meeting and Event Administrative Coordination
• HR and Administrative Support
• Office Supplies and Daily Administration

RA Ops Specialist

Clinical Research

• Manage external vendors and contract research organizations
• Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, and Laboratory Manual
• Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards, and source documents
• Assist with protocol development and study report completion
• Manage monitoring activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols
• Provide guidance, direction, and management to CRAs
• Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports
• Coordinate study supplies
• Negotiate contracts with vendors of clinical trial services
• Review Informed Consent Forms, CRFs, and study-related materials
• Plan and participate in investigator meetings
• Assist and support the data query process
• Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines
• Ensure trial master file is current and maintained
• Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials

Junior Clinical Trial Manager

Compliance

• Ensuring compliance with Health Authority drug promotion and promotional labeling regulations
• Reviewing, approving, or rejecting promotional programming
• Collaborating with Commercial Operations Marketing, Legal, and Medical personnel
• Monitoring and applying trends in regulation of advertising and promotional labeling
• Providing regulatory leadership and guidance to marketing teams
• Preparing and submitting advertising and promotional labeling materials to Health Authorities

Regulatory Affairs Consultant – Advertising & Promotional Labeling

Clinical Operations

• Responsible for performance and compliance for assigned protocols.
• Manages country deliverables, timelines, and results for assigned protocols.
• Oversees Clinical Trial Coordinators as applicable.
• Coordinates and liaises with Clinical Research Managers, Clinical Research Associates, and more.
• Develops local language materials including local language Informed Consents and translations.
• Influences investigators, external partners, and country operations to adhere to budget targets.

Clinical Operations Manager – FSP

Attorney

• Provide contract management to support clinical trials
• Review and negotiate Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), and Informed Consent Forms (ICFs)
• Build strong working relationships with CRO contracting staff
• Track and drive contracts to execution

Senior Site Contracts Leader – Research and Development, Legal

Software Engineer

• Serve as Statistical Programming Lead on assigned projects.
• Lead programming teams to deliver high‑quality outputs within agreed timelines and budget.
• Drive project planning activities including start-up, resource allocation, and development of global programs and tracking tools.
• Review statistical analysis plans (SAPs), mock shells, and database specifications.
• Partner closely with sponsors, Biostatistics Leads, Data Management, and other stakeholders.
• Monitor scope, resources, productivity, and project financials.
• Support issue resolution and ensure smooth day‑to‑day study execution.
• Develop and QC SDTM, ADaM datasets, analysis outputs, tables, listings, and figures.
• Create and QC dataset specifications, study-level documentation, and regulatory submission materials.
• Ensure all programming activities meet corporate quality standards, SOPs, ICH‑GCP, and regulatory requirements.
• Demonstrate consistent first-time quality in deliverables through rigorous QC practices.
• Maintain and deepen knowledge of global clinical and regulatory standards.
• Mentor team members and provide project-specific training.
• Lead knowledge-sharing initiatives across the department.
• Maintain study documentation to ensure traceability and regulatory readiness.
• Participate in audits and inspections as needed.
• Contribute to process improvement, technology assessments, and operational optimization.
• Provide expert programming consultancy to sponsors.
• Represent Statistical Programming on cross-functional initiatives and external meetings.

Principal Statistical Programmer

Artificial Intelligence

• Define and evolve Parexel’s enterprise AI strategy, roadmap, and investment portfolio.
• Identify priority use cases aligned to business value, feasibility, and regulatory constraints.
• Conduct AI maturity assessments and establish long‑term capability-building plans.
• Define standards for model lifecycle management, validation, auditability, and transparency.
• Ensure compliance with GxP, global regulatory guidance, and responsible AI principles.
• Drive scalable architecture for GenAI, ML operations, retrieval‑augmented generation, and secure model hosting.
• Lead AI product teams delivering enterprise and function‑specific solutions.
• Align AI programs with broader Data & Technology strategy and transformation goals.
• Build and lead a global organization of AI product managers, engineers, data scientists, and AI governance specialists.

Vice President, AI Enablement

ServiceNow

• Manage day‑to‑day administration of the ServiceNow platform, including user management, roles, groups, ACLs, and data integrity.
• Monitor system performance, scheduled jobs, integrations, and overall platform health.
• Maintain CMDB accuracy and support discovery, service mapping, and asset management activities.
• Apply platform upgrades, patches, and hotfixes while ensuring minimal disruption.
• Enforce governance, best practices, and compliance with organizational standards.
• Design and implement solutions using ServiceNow modules such as ITSM, ITOM, ITAM, CSM, or others as required.
• Build and customize applications, workflows, business rules, UI policies, client scripts, and integrations.
• Develop and maintain REST/SOAP integrations with external systems.
• Create and enhance catalog items, record producers, and automation workflows.
• Implement custom UI pages, dashboards, and reporting solutions.
• Work closely with stakeholders to gather requirements and translate them into technical solutions.
• Participate in Agile ceremonies, sprint planning, and backlog refinement.
• Provide technical guidance, documentation, and knowledge transfer to internal teams.
• Troubleshoot issues, perform root cause analysis, and implement long‑term fixes.
• Support governance processes, including change management and release management.

Senior ServiceNow Administrator

• Responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements
• Monitoring will be conducted in line with the Study Monitoring Plan (SMP)
• Collaborate with the Site Manager to assure that the site complies with the protocol and is inspection ready
• Conduct monitoring activities using different methods, both on site and remote
• Conducts source document review and verification of appropriate site source documents and medical records

Senior Clinical Research Associate – Oncology Experience Essential

IT Support

• Lead GxP Audits: Independently plan, conduct, and report on audits across all clinical research phases, including project audits, system audits, supplier qualifications, TMF audits, and pharmacovigilance audits
• Deliver Quality Results: Complete high-quality audit reports within timelines and budgets, including complex for-cause and co-audits with clients
• Drive Compliance: Support Serious Breach investigations, provide regulatory guidance on GxP requirements, and facilitate client audits and regulatory inspections
• Ensure Follow-up: Review CAPA responses, escalate delays, and consult with Operations and Quality teams on implementation
• Contribute to Excellence: Help develop and improve Parexel procedures, systems, and audit strategies

Audit Specialist – Sponsor Audits, Inspections

Conversion Rate Optimizer

• Manage integration of project team activities
• Manage strategic study operations including study sites and tracking systems for regulatory submissions
• Provide input on trial level operational strategies for clinical trials
• Manage aspects of CRO/vendor identification and day-to-day operational management activities of CROs and other vendors

UK Clinical Trial Manager – CRO Oversight – FSP

Medical Director

• Independently deliver all medical support required for successful delivery of the projects
• Actively listen and address client feedback and suggestions regarding medical study-related activities
• Provide medical expertise in Proposal Development Teams

Senior Medical Director, Oncology

Director

• Define and lead the technology quality strategy
• Oversee lifecycle validation activities for all D&T systems
• Ensure compliance with Technology SOPs
• Lead the definition, deployment, and continuous improvement of technology delivery processes
• Oversee and execute testing activities across multiple frameworks
• Govern the process for reviewing vendor validation packages
• Collaborate with D&T and business executive leadership

Executive Director, D&T Quality Validation, Process

• Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.
• Assess change controls and provide regulatory assessments of quality changes in production and quality control.
• Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
• Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
• Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
• Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
• Identify, escalate, and mitigate risks associated with regulatory procedures and activities.