Parexel

Project Manager

• Oversee the management and leadership of Parexel's Patient Safety pillar
• Provide oversight of processes and functions related to the delivery of a program or portfolio of Patient Safety Services
• Lead operational level planning with significant business oversight
• Drive ‘positive change’ throughout Parexel through continuous process improvement programs
• Make significant contributions to the leadership of the Business Unit and the development of the strategy and direction of the BU
• Act as a mentor, support and direct functional team to develop robust patient engagement strategies
• Facilitate functional team metrics collection and case study creation to support the Patient Safety organization

Executive Director – Project Management, Patient Safety

Director

• Lead strategy, design, and roadmap for enterprise reporting and analytics aligned to operational, clinical, financial, and safety needs
• Drive the creation of standardized enterprise metrics, KPIs, and dashboards
• Ensure consistent definitions and alignment with Data Governance and MDM
• Lead engineering teams responsible for ingestion, transformation, storage, and optimization of enterprise data in the Enterprise Data Lake
• Oversee performance, reliability, security, and lifecycle of data lake environments
• Ensure all data domains have scalable engineering pipelines aligned with governance requirements
• Lead teams responsible for API engineering, backend integration, and enterprise data flow
• Drive high-quality, validated data preparation and staging for reporting and analytics
• Build, mentor, and lead global teams across data engineering, data modeling, visualization, and integration engineering

Executive Director – Data Aggregation, Reporting

Compliance

• Drive the labeling development and strategy, in-line with overall global strategy.
• Provide labeling expertise for Company Core Data Sheet (CCDS) and local labeling (USPI, SmPC and other).
• Evaluate and communicate strategies and anticipate risks associated with labeling content and timelines.
• Lead or contribute to cross-functional teams to align the development and maintenance of global labeling for assigned compounds.
• Partner with Global Regulatory Affairs to ensure all labeling is aligned with product global strategy.
• Support global Health Authority interaction strategy regarding all aspects of labeling.
• Collaborate with global colleagues and partners as needed.
• Develop clear communications for senior management and labeling stakeholders.

Regulatory Affairs Consultant – Global Labeling Lead

• Partner with a large global biopharmaceutical client and lead regulatory CMC strategy for peptide and oligonucleotide therapeutics
• Drive global regulatory strategy and submission activities for complex synthetic and nucleic acid–based products
• Collaborate closely with R&D, CMC, clinical, and quality teams to ensure compliance with international standards and accelerate successful product approvals

CMC Regulatory Affairs Consultant, Peptides and Oligonucleotides

• Serve as the primary D&T executive partner for the global Site & Study Startup function.
• Drive system enhancements that improve startup predictability, data capture, cycle times, and risk identification.
• Provide technology, analytical models, and data tools for feasibility assessments.
• Enable real‑time access to feasibility insights, performance history, and site data across data platforms.
• Oversee integrations between Site & Study Startup systems and broader D&T ecosystem systems.
• Build and scale reporting capabilities that measure startup progress, activation risks, feasibility metrics, and regulatory timelines.
• Lead a global team of product owners, business analysts, solution architects, and technologists supporting Site & Study Startup systems and processes.

Executive Director – Data & Technology

Research Analyst

• APEX Clinical Research Associate (CRA) providing foundational clinical research training
• Perform billable project tasks to support CRAs and Clinical Operations Leads
• Collaborate with CRAs for observational and co-monitoring support
• Address and resolve site issues and questions
• Manage site quality and delivery from site identification through to close-out

Clinical Research Associate, APEX

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
• Co-chair AI governance and define standards for model lifecycle management, validation, auditability, and transparency
• Ensure compliance with GxP, global regulatory guidance, and responsible AI principles
• Partner with Quality, Legal, and Compliance to operationalize risk management for AI systems
• Oversee enterprise AI platforms, tooling, and data pipelines
• Drive scalable architecture for GenAI, ML operations, retrieval‑augmented generation, and secure model hosting
• Evaluate and integrate vendor platforms while ensuring data privacy and clinical-grade security
• Lead AI product teams delivering enterprise and function‑specific solutions
• Establish repeatable implementation frameworks, delivery methodologies, and KPIs
• Identify value-add vendor partners and co-develop and deploy AI based capabilities
• Drive user adoption programs, training pathways, and change management across global teams
• Serve as executive AI advisor to senior leadership including Clinical Development, Commercial, Regulatory, Legal, Quality, and Operations
• Align AI programs with broader Data & Technology strategy and transformation goals
• Represent Parexel externally with partners, clients, and industry bodies
• Build and lead a global organization of AI product managers, engineers, data scientists, and AI governance specialists
• Develop talent pathways and partnerships to ensure cutting‑edge expertise

Vice President, AI Enablement

Clinical Operations

• Serve as the senior D&T leader accountable for all technology capabilities supporting Clinical Operations, including operational systems, workflows, and data pipelines.
• Ensure system reliability, user readiness, and operational optimization for global Clinical Operations teams.
• Align technology and process improvements with Clinical Operations’ goals for efficiency, accuracy, and cycle‑time reduction.
• Oversee integrations between Clinical Operations systems and the broader D&T ecosystem (data lake, reporting, enterprise integration platforms).
• Ensure accurate and timely data flows across operational technologies used in clinical execution, safety, regulatory, and cross-functional processes.
• Oversee maintenance, upgrades, validation, and enhancement of Clinical Ops–related platforms.
• Ensure alignment with validation, SDLC, compliance, and quality frameworks.
• Ensure system retirement, consolidation, and introduction of new capabilities follow enterprise standards.
• Represent Clinical Operations in enterprise governance forums, including Data Governance, Portfolio Planning, and Operational Excellence bodies.
• Lead intake and prioritization discussions for all Clinical Operations technology requests, in coordination with PMO/Portfolio teams.
• Ensure Clinical Operations-related initiatives align with broader D&T strategy, organizational restructuring decisions, and operational goals.
• Lead a global team of managers, business systems analysts, product owners, and engineers supporting Clinical Operations.
• Create career development paths aligned with operational, data, and system leadership needs.
• Build a culture of excellence, accountability, and collaboration across operations and technology staff.

Executive Director, Data & Technology – Clinical Operations

• Play a crucial part in coordinating various Global regulatory submissions ie. INDs, IMPDs, BLA/NDS/MAA post-approval commitments
• Assist in the preparation and coordination of global regulatory submissions, ensuring all submissions are complete, accurate, and compliant with regulatory requirements
• Manage submission timelines and coordinate with cross-functional teams to gather necessary documentation
• Support the team in conducting regulatory assessments of manufacturing changes, analyze the potential impact, and assist in preparing documentation to support manufacturing change assessments
• Facilitate effective communication between cross functional teams and regulatory authorities
• Participate and facilitate project team meetings to provide regulatory input and updates
• Maintain accurate and up-to-date regulatory documentation

Regulatory Affairs Associate

Clinical Research

• Provide leadership and direction to the trial team and be accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI’s.
• Responsible for steering and directing clinical trial activities, including patient and site engagement activities.
• Direct communication and interaction with multiple internal and external stakeholders, and team members on a global, multi-country or regional basis.
• Accountable for the accurate planning and operational feasibility of trial timelines; oversee trial preparation to ensure trial team members are aligned and on track.
• Supports development of trial level documents owned by other functions.
• Verifies and provides input into the country allocation and oversees trial feasibility.
• Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation.
• In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting.
• Prepare and implement amendments of core documents, including training material updates/retraining as needed.
• Responding for timely, complete and compliant archiving of all relevant global documents in the TMF, including all required documents from vendors.

Global Clinical Trial Lead – Senior Clinical Trial Manager

• Responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level.
• Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the majority of activities to supplement on site visit requirements.
• Collaborate with the Site Manager to assure that the site complies with the protocol and is inspection ready.
• Conduct monitoring activities using different methods, e.g., both on site and remote, where allowed by country regulations.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company Standard Operating Procedures (SOPs)/processes.

Senior Clinical Research Associate – Oncology Experience Preferred

• Working as a Site Monitoring Lead you will be a key member of the global Clinical Trial Team
• SMLs are accountable for authoring the monitoring risk assessments and plans
• Ensuring sponsor oversight, trend analysis, signal detection and delivery of your assigned trials in close collaboration with the CRO partner
• Safeguard the protection of the trial subject, reliability of the trial results, compliance with study protocol, sponsor obligations, ICH-GCP and applicable regulations
• Coordinating timely cleaning and delivery of clinical trial data with Trial Team and countries

Site Monitoring Lead – Clinical Operations Lead

Accountant

• Proactively take responsibility for all aspects of transactional accounting and reporting.
• Prepare and process GL monthly journals entries with sufficient support documentation providing a clear audit trail.
• Ensure all balance sheet accounts are reconciled and analysed on a monthly basis.
• Perform Accrual entries on an aged basis and document review on a monthly basis.
• Manage the timely review/reversal of Accruals and collaborate with the cross functional team for resolution.
• Manage the clearing process for specific large balances.
• Coordinate the completion of the monthly/quarterly/yearly intercompany account reconciliation and resolutions.
• Prepare monthly reports, quarterly and year end packages.

Senior GL Accountant

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP)
• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites
• Serve as the primary point of contact for assigned investigator sites
• Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities

Senior Clinical Research Associate – FSP

• Contribute to preparation (including authoring where relevant) and delivery of regulatory submissions from a global and regional perspective.
• Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada Switzerland, Australia.