Parexel

Manager

• Provide leadership and direction to the trial team
• 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; and oversight of trial preparation to ensure trial team members are aligned and on track
• Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring)
• 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
• Supports budget oversight, including regular clinical quality monitoring, SMC/DMC management and safety reporting
• Prepare and implement amendments of core documents, including training material updates/retraining as needed.
• Support authority/ethics response to requests as applicable
• Ensures timely cleaning and delivery of clinical trial data
• Coordinates and supports trial medical writer in providing the CTR.
• Responsible for timely, complete and compliant archiving of all relevant global documents in the TMF
• Support results/documents disclosure of global registries.

Global Study Manager II

Analyst

• Negotiate and maintain Clinical Trials Agreements (CTA), site budgets, Confidential Disclosure Agreements, Consultant Agreements, and other applicable contracts
• Oversee CRO or Functional Service Provider in the development of clinical site budgets
• Ensure compliance of contracts with Fair Market Value (FMV) principles and guidelines
• Track contract progress and complete required follow-ups
• Collaborate and coordinate with cross-functional teams
• Develop, maintain, and analyze tools and systems to manage contract lifecycle
• Provide guidance and direction to new clinical operations and/or outsourcing team members
• Assist management with process improvement projects
• Prepare agendas and meeting planning

Senior Analyst, Site Contracts and Budgets

Communications

• Provide skilled, proactive project coordination support to assigned account team(s) and allocated projects
• Ensure efficient project management with minimal supervision
• Maintain internal project tracking systems
• Maintain internal/client databases and documentation
• Prepare for team meetings, including scheduling, material preparation, and minute-taking
• Maintain client publication/medical affairs tracking tools (e.g., Datavision, PubStrat, Veeva Vault)
• Assist with financial tracking of projects, including preparing hour reports and invoice schedules
• Coordinate arrangements for client, authors, and faculty/KOL meetings
• Organize own workload, prioritizing work through regular discussions with Manager
• Organize travel and accommodation for team members, make arrangements for client visits and off-site meetings

Medical Communications Program Coordinator

Research Analyst

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices.
• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through database lock, ensuring relevant timelines and quality deliverables are met.
• Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites.
• Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution.
• Serve as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks, when applicable

Senior Clinical Research Associate – FSP

• Provide operational leadership throughout the study lifecycle
• Oversee and execute study management, site management, preferred Contract Research Organization, and vendor deliverables for all study management deliverables in a study
• Lead and coordinate the execution of a clinical trial globally from sourcing strategy and study specification development for requests for proposals to fully outsourced studies and ancillary vendors
• Drive decision making and work closely with the Clinical Study Team to provide input to operational strategy
• Supervise and/or mentor country trial managers and possibly other junior GSMs
• Ensure development of study level plans, including the study monitoring and study training plans
• Develop, review, or approve the study startup, study monitoring, protocol recruitment, and training plans and other documents, guidelines, and plans
• Champion the implementation and use of harmonized, consistent processes, and excellence in study management deliverables

Global Study Manager – FSP

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices.
• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through database lock, ensuring relevant timelines and quality deliverables are met.
• Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites.
• Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution.
• Serve as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks, when applicable.

Senior Clinical Research Associate

Project Manager

• Provide leadership for the project management team within D&T - Business Engagement & Enablement
• Ensure excellence in project delivery, portfolio governance, and execution of the company’s technology and business transformation initiatives
• Lead, mentor, and develop a team of global Project Managers, ensuring strong delivery discipline, stakeholder management, and adherence to methodology
• Foster a culture of accountability, collaboration, honesty, transparency and continuous improvement
• Ensure compliance with the enterprise portfolio governance model, including intake, prioritization, business case evaluation, and ongoing performance monitoring
• Partner with stakeholders to ensure portfolio aligns to business strategy, technology roadmap, and capacity constraints
• Define, maintain, and continuously improve the project management methodology, lifecycle processes, templates, KPIs, and associated governance frameworks

Senior Director, Project Management, D&T – Business Engagement & Enablement

Data Scientist

• Contributes statistical capabilities and methodological leadership at all stages of projects.
• Works with junior team members in designing, developing, and delivering client solutions across multiple projects.
• Directs project teams in the design, development, and delivery of client solutions across multiple projects.
• Provides high level input to the development of client deliverables including the provision of support to the delivery team.
• Manages existing business accounts and identifies new business opportunities for Parexel.
• Mentors and develops members of the team to help achieve best in class status.

Principal Consultant, Advanced Analytics – Data Science, AI

Clinical Research

• Coordinate and lead a project team to successful completion of a project within timelines and budget
• Interact with clients as key contact with regard to statistical and contractual issues
• Perform QC of derived datasets, tables, figures and data listings produced by other members of the department
• Check own work in an ongoing way to ensure first time quality
• Understand and apply advanced statistical methods

Senior Biostatistician

Compliance

• Understand regulatory frameworks and procedural requirements
• Provide regulatory input on documentation for submissions
• Liaise with cross-functional team members

Regulatory Affairs Associate

Inside Sales

• Work strategically with Marketing and Sales Teams to generate marketing campaigns for all lines of the Parexel business including promoting webinars, customer days and other marketing-driven events.
• Analyze potential opportunities and develop strategies to support increasing client awareness and engagement; monitor actions and results against plans
• Schedule introductory business development calls between sales team members and target company decision-makers.
• Work closely with Sales Associates and Account Executives to ensure smooth transfer of information and accounts.
• Collaborate with Director of Market Development, senior Sales staff, and Subject Matter Experts to develop market strategies to generate leads with new clients; re-engage past clients, and within current core accounts across all Parexel service lines.
• Respond to Parexel web leads / inbound requests as first point of contact to conduct needs assessment
• Track all activity with prospects and clients in Parexel’s CRM system
• Other responsibilities as assigned

Inside Sales – Market Development Analyst

• Lead investigations and CAPA management for labeling-related deviations, driving root-cause analysis, trend identification, and cross-functional remediation
• Oversee E2E labeling process updates, escalation management, and process-to-system alignment
• Serve as CAPA Owner for process improvements and ensure clear communication of changes to stakeholders
• Support business partners and Safety Data Exchange Agreement obligations, ensuring roles, responsibilities, and clear process management are established to comply with contractual terms and conditions
• Act as Business Contact for Veeva RIMS, TrackWise, QDocs, and related systems
• Oversee system enhancements, issue resolution, and workflow maintenance
• Ensure effective process-to-system handoffs to support compliant and efficient labeling operations
• Lead preparation and coordination for audits and inspections, ensuring a 'permanently inspection-ready' environment
• Maintain the Global Labeling Audit & Inspection Storyboard and develop supporting process flow maps
• Produce required system outputs and documentation, and support key SMEs and stakeholders during inspection interviews
• Serve as Veeva COP (Community of Practice) process expert and drive continuous improvement initiatives
• Ensure consistency of E2E labeling process handoffs across functions and regions
• Partner with Regulatory, Pharmacovigilance, Quality, and Manufacturing to address systemic issues and strengthen interdependencies
• Develop and deliver Global Labeling training materials
• Contribute Global Labeling perspective to regulatory intelligence reviews and process impact assessments

Senior Regulatory Affairs Associate – Labeling Compliance

Data Engineer

• Support project teams in the design, development, and delivery of RWD solutions across multiple databases.
• Manage the inflow of diverse healthcare data sources and ensure data quality.
• Develop technical specifications and transform data into a common data model.
• Publish validated datasets for enterprise-wide use.
• Provide reports, presentations, and technical explanations to epidemiologists, analysts, and programmers.
• Communicate with data vendors and ensure accountability for data quality.
• Help ensure quality standards and evaluate new methodologies.
• Perform SQL querying, transformation, and quality control.
• Apply SAS, Python, and programming tools to support analytical workflows.
• Work with real-world healthcare datasets (Optum, PharMetrics, Flatiron, registry data).
• Support OMOP data model conversions.
• Leverage AI tools such as Databricks Genie and MS Copilot.
• Work independently or as part of a team.

RWD Data Engineer

IT Support

• Respond to and resolve user requests and incidents through the service desk ticketing system
• Provide first-level troubleshooting for hardware, software, network, and peripheral issues
• Configure and install computer equipment, software applications, and peripherals
• Perform basic diagnostics to identify technical problems and determine appropriate solutions
• Escalate complex issues to appropriate IT teams following established procedures
• Document all support activities, including problem details and resolution steps
• Follow up with users to ensure satisfactory resolution of technical issues
• Create, modify, and disable user accounts according to established procedures
• Reset passwords and assist users with account access issues
• Manage user permissions and access rights based on role requirements
• Maintain accurate records of user account activities and changes
• Support onboarding and offboarding processes for employees by managing their IT assets and accounts
• Ensure compliance with security policies for account management
• Install, configure, and update software applications used in clinical research environments
• Set up workstations, laptops, tablets, and mobile devices for new and existing users
• Perform basic hardware repairs and replacements (memory, hard drives, peripherals)
• Conduct regular maintenance activities to ensure optimal system performance
• Support audio/visual equipment for meetings and presentations
• Assist with inventory management of IT assets and equipment
• Prepare devices for deployment with standard configurations and software packages
• Provide basic training to users on standard software applications and systems
• Create and maintain end-user documentation and quick reference guides
• Assist users with questions about software functionality and best practices
• Promote self-service options and knowledge base resources to users
• Educate users on IT policies, security practices, and proper equipment usage
• Support remote users with connectivity and access issues
• Participate in routine system maintenance activities under supervision
• Assist with basic network troubleshooting and connectivity issues
• Monitor system alerts and notifications for potential issues
• Perform scheduled backups and verify their completion
• Support disaster recovery and business continuity testing
• Maintain organized IT work areas, equipment storage, and repair facilities
• Assist with physical inventory audits of IT assets
• Maintain accurate records of all support activities in the service desk system
• Document common issues and solutions for knowledge base articles
• Generate basic reports on support metrics and service levels
• Update technical documentation for supported systems and processes
• Record hardware and software inventory changes
• Document user training activities and materials
• Maintain logs of recurring issues for trend analysis
• Ensure adherence to IT security policies and procedures
• Assist with basic security measures such as antivirus updates and patches
• Report potential security incidents to appropriate personnel
• Support compliance with data protection regulations in clinical environments
• Maintain confidentiality of sensitive information and systems
• Follow established procedures for handling regulated systems
• Participate in security awareness activities and training

IT Support Specialist I

• Works effectively within a team environment but may work independently delivering services within their area of competence
• Works within broad project guidelines as directed by the project lead and/or technical SMEs
• Takes initiative to prioritize work to achieve specified project outcomes while confirming alignment with project lead and line manager
• Applies information provided by the project lead or senior colleagues to complete assigned project activities
• Produces quality work that meets the expectations of project lead and the client
• Serves as a Project Lead for small scale projects or a Work Stream Lead on larger projects when serving as a Project Lead
• Responsible for project planning and set-up and routinely interacts with the assigned Project Specialist (PS) or Project Manager (PM)
• Ensures that the project team delivers to meet the client expectations for quality and timeliness
• Ensures that appropriate risk identification and issue-escalation procedures are in place
• Ensures and/or manages project financials including provision of accurate revenue forecasts
• Identifies new opportunities through Change In Scope or add-on business from existing work
• Interacts professionally at all working levels within a client organization and within PAREXEL.