Parexel

General

• Lead project delivery and oversight for Biotech clients globally.
• Develop and maintain formal project plans with milestones, budgets, and resources.
• Identify project risks and implement contingency plans.
• Establish quality standards and drive commitment to project deliverables.
• Own the client relationship and ensure high satisfaction.
• Manage project P&L, revenue recognition, and budgeting.
• Enable all stakeholders for successful study completion.
• Represent Project Leadership function in client meetings and presentations.

Clinical Project Leader – Biotech

Manager

• Provide technical expertise for the category throughout start-up to close out
• Support implementation of defined category strategies and service standardization
• Ensure compliance through the life of the studies assigned
• Proactively assess risk and conclude contingency plans to de-risk study start-up
• Review of the IRT vendor and category related specific sections of the protocol
• Contribute to development of Study Specification Worksheet (SSW)
• Ensure all submission documents are provided by vendor to countries participating in a study
• Support for program overview by providing study demands to VCE
• Ensure changes to country and site plans are consistently shared with vendors and VCE
• Document issues identified with vendor oversight / performance
• Drive root cause analysis of supplier performance issues
• Collaborate across sponsor’s departments to provide data for vendor qualification efforts
• Review and approve invoices against activity

IRT Vendor Start-up Manager – FSP

Director

• Lead the strategic transformation, modernisation and operational delivery of Quality Engineering (QE), testing, automation and quality assurance capabilities across Parexel’s global Data & Technology (D&T) organisation
• Own and execute the enterprise Quality Engineering strategy across Data & Technology, positioning QE as a strategic business enabler across Parexel
• Oversee enterprise-wide testing and QE delivery across regulated and non-regulated systems
• Establish standards for test planning, execution, automation, traceability, evidence management, defect governance, quality gates and release readiness
• Own enterprise automation engineering frameworks, standards and tooling strategies that increase automation coverage, reusability and efficiency
• Lead globally distributed QE delivery teams, including vendor-supplied resources, offshore teams and strategic partners
• Ensure QE practices align to regulatory expectations, GxP requirements and enterprise quality standards where applicable
• Build, lead and develop high-performing global QE and testing teams across multiple functions and geographies
• Partner with Business, senior D&T, Quality, Engineering and Operational leaders to align QE strategy with enterprise objectives
• Lead enterprise quality improvement programmes focused on efficiency, effectiveness, customer experience and speed to market

Associate Director, Software Quality and Testing

Associate

• Drafting & negotiating contracts — clinical study agreements, service agreements, team member agreements, and related documents.
• Interpreting site feedback within local legal and business frameworks to guide internal decision‑makers.
• Ensuring compliance with ICH‑GCP, local laws, and internal guidelines.
• Managing the full contract lifecycle — from first draft to final signature and archival.
• Building strong relationships with clinical trial sites and internal stakeholders.
• Spotting risks early and collaborating with the Site Contract Lead to resolve them.
• Tracking progress in real time and keeping teams informed.
• Driving process improvements to make contracting faster, clearer, and more efficient.

Site Contracts Associate I/II

Clinical Operations

• Tracking, scanning, filing, entry and return of Case Report Forms to clients for assigned projects
• Managing documents in the electronic document management system
• May have limited contact with investigator sites in context of supporting CRAs

Clinical Operations Assistant

Research Analyst

• Oversight of Monitoring Responsibilities and Study Conduct
• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality
• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
• During study conduct, serve as the primary point of contact for assigned investigator sites

Senior Clinical Research Associate / Clinical Research Associate II – Oncology

• Lead global clinical operations strategy and execution for assigned clinical trials.
• Drive study startup including site selection, monitoring strategy, and operational planning.
• Coordinate cross functional teams across geographies ensuring alignment on timelines quality and deliverables.
• Monitor study progress including recruitment retention data quality and timelines and take corrective action when needed.
• Identify risks early and implement mitigation and contingency plans.
• Provide leadership direction and performance feedback to project team members.
• Function as primary point of contact for sponsors on clinical operations topics.
• Ensure compliance with ICH GCP regulatory requirements and internal processes.
• Oversee maintenance and quality of study documentation and central files.
• Support audits inspections and study closeout activities including database lock and archiving.
• Provide strategic oversight of the integrated data delivery (IDD) framework and champion a proactive data-quality culture

Global Clinical Operations Leader – Clinical Trial Manager

Strategy

• Lead feasibility and strategy development to ensure optimal clinical trial delivery across countries, sites, and patient populations
• Deliver data-driven feasibility strategies to identify the right countries, sites, and patient populations
• Lead risk-based feasibility analysis and recommend solutions to mitigate delivery challenges
• Partner with Patient Recruitment Strategy and Site Alliance teams to create integrated strategies
• Create compelling, high-quality proposal content that differentiates Parexel
• Present strategic approaches in bid pursuit and capability meetings
• Collaborate with cross-functional teams to support winning new business
• Drive innovation in feasibility processes, data, and methodologies
• Contribute to therapy area strategy and continuous improvement initiatives
• Build strong partnerships across global teams and functions
• Engage with internal and external stakeholders, vendors, and key opinion leaders

Senior Feasibility & Strategy Leader

• Act as Parexel’s direct contact with assigned sites
• Assess and ensure overall integrity of study implementation and adherence to study protocol
• Build relationships with investigators and site staff
• Evaluate if on-site staff assignment is still accurate
• Apply working knowledge and judgment to identify potential data quality issues
• Monitor and maintain compliance with ICH-GCP and applicable regulations
• Perform site facilities assessments
• Ensure timely and accurate completion of project goals

Clinical Research Associate I/II

• Contributes statistical capabilities and methodological support at all stages of projects
• Works under the supervision of an experienced team member
• Designs, develops, and delivers client solutions across multiple projects
• Leverages competencies in statistical theory, data analysis and interpretation, regression analysis, and experimental design
• Acts as support biostatistician or statistical programmer to interact with the study team and the sponsor
• Supports in drafting statistical sections of protocols, performing sample size and power calculation for studies
• Contributes to the preparation of specifications for analysis datasets
• Reviews study protocols and provides input to statistics section

Health Economics Associate – Fixed-term Contract

• Perform site management activities to ensure compliance with the protocol, monitoring plan, ICH GCP, local regulatory requirements, and client SOPs.
• Conduct site qualification, initiation, interim, and close-out visits, both on-site and remotely.
• Partner with Clinical Trial Liaison (CTL) and other client functions to support site activation and deliverables.
• Establish and maintain productive professional relationships with investigator site staff, ensuring effective communication and problem-solving throughout study conduct.
• Perform drug accountability, reconciliation, and destruction, ensuring protocol compliance for storage and shipment requirements.
• Prepare and maintain Oversight Monitoring Plan.
• Conduct Oversight Monitoring Visits at sites, either independently or alongside CRO CRA.
• Ensure site regulatory files are current and verify timely submission of study documentation, including safety reporting.
• Identify and record protocol deviations, escalate non-compliance, and resolve study-related issues as necessary.
• Maintain ongoing communication with site personnel, study teams, CTLs, Central Monitors, and CRO CRAs.

Senior Clinical Research Associate

Compliance

• Develop import/export strategies for international projects
• Ensure compliance with global trade regulations
• Oversee trade activities and manage regulatory risks
• Collaborate with cross-functional teams to achieve project objectives

Global Trade Compliance Leader

• Serve as the primary technology advisor for multiple strategic client accounts
• Build and maintain strong relationships with senior client stakeholders
• Lead executive-level client interactions, including quarterly business reviews, strategy sessions, and roadmap discussions
• Partner with clients to understand their technology landscape, priorities, and long-term roadmap
• Align internal capabilities and solutions to client strategies and upcoming initiatives
• Act as the central point of coordination across IT, architecture, operations, commercial, and delivery teams
• Plan and facilitate structured meetings with clear agendas and objectives
• Partner with commercial and contracts teams to support proposals, estimates, and statements of work
• Maintain visibility across client engagements, including progress, risks, and key dependencies
• Identify opportunities to improve processes, solutions, and client outcomes

Director, Client Technology Partner

Software Engineer

• Design, code, test, correct and document complex programs and scripts
• Specify user/system interface and translate logical designs into physical designs
• Produce detailed design and document all work using required standards

Senior Power Apps Developer

• Manage all operational aspects of clinical trial activities at assigned investigator sites, ensuring timelines and quality deliverables are consistently met
• Serve as the primary point of contact for investigator sites, fostering collaborative relationships with site personnel, study teams, and vendors
• Conduct thorough site monitoring activities—both onsite and remote—to maintain protocol compliance and safeguard patient welfare
• Identify and resolve site issues promptly, develop corrective actions, and support quality event remediation
• Partner with study teams to facilitate investigator meetings, provide enrollment support, and drive recruitment initiatives
• Submit timely reports, maintain trial master files, track protocol deviations, and monitor clinical supply management
• May mentor Clinical Research Associates and coach site personnel on protocol requirements and best practices