Parexel

Compliance

• Ensure timely performance of work within project scope to quality expectations of internal stakeholders and clients
• Act as Project Lead or Work Stream Lead
• Assure the work of the team is delivered on time and meets clients’ quality expectations
• Manage local submissions as Local Regulatory Contact (LRC)
• Coordinate regulatory submissions in participating countries as Regulatory Lead
• Participate in Regulatory Operations meetings, project team meetings
• Maintain relationships with other departments, clients, and regulatory agencies
• Involve in local, regional, and/or global projects

Senior Regulatory Affairs Associate – Clinical Trial Applications

Financial Planning and Analysis

• Process approvals and payments for invoices submitted by sites/vendors; ensure payments are within contractual agreements.
• Ensure appropriate coding processes are followed for efficiency and consistency.
• Identify out of balance accounting records and reconcile with site/vendor/ Parexel and the finance department.
• Communicate directly with the site and vendors to resolve invoice differences.
• Conduct Quality Control process reviews and remediate as needed.
• Maintain the clinical financial database.
• Ensure documentation is maintained to support an audit trail in the accounting system.
• Support the Clinical relationship with Finance.
• Interface with Accounting for the close/reconciliation process.
• Serve as the Clinical Finance representative for study teams.
• Provide data for clinical trial forecasting and budgeting process.
• Ensure current insurance information and documentation is conveyed appropriately to broker.
• Anticipate clinical trial budget revisions due to out-of-scope services, enrollment delays, etc.
• Process financial termination/closure of study sites.
• Process monthly clinical dashboard.
• Provide actual cost budget analysis.
• Manage special projects as required.
• Adhere to appropriate quality documents (e.g., SOPs, Training Guides), as applicable.

Clinical Finance Analyst II

• Manage end-to-end labeling lifecycle including preliminary assessment, implementation, and post-approval maintenance
• Provide innovation and technical expertise for the creation, maintenance, and implementation of labeling to meet country-specific regulatory requirements
• Execute labeling operations globally with precision and efficiency
• Participate in a 'follow the sun' model to ensure timely execution of labelling activities across time zones
• Prepare and review labelling documents for regulatory submissions and variations
• Maintain labeling databases and tracking systems
• Support global labelling harmonization initiatives
• Collaborate with regional regulatory teams to ensure compliance with local requirements
• Monitor regulatory intelligence related to labelling requirements

Regulatory Affairs Consultant, Labelling – German Speaker

• Provide end‑to‑end regulatory affairs support for partnered assets
• Maintain U.S. regulatory archive logs
• Support cross-functional clinical trial team meetings
• Draft administrative components of regulatory submissions
• Prepare, review, and submit periodic post marketing regulatory reports
• Maintain tracking and compliance with global post approval commitments

Senior Regulatory Affairs Associate – Generalist

Manager

• Lead the strategy, operations, and financial management of Parexel’s global network environment.
• Manage vendor relationships including contracts, performance, and escalations.
• Own and optimize financials across network, telecom, and AV (budgeting, forecasting, cost reduction).
• Drive standardization across global sites.
• Partner with Security on network segmentation, voice security, and compliance requirements.
• Act as escalation point for major incidents across network, voice, and AV.

Senior Manager, Enterprise Infrastructure – Networking

Research Analyst

• Drive study performance at the sites.
• Perform site monitoring and other onsite visit activities according to monitoring plan and in compliance with procedural documents.
• Provide the required monitoring visit reports within required timelines.
• Proactively identify study-related issues and escalates to Local Study Teams as appropriate.
• Contribute to the selection of potential sites and investigators.
• Train, support and advise Investigators and site staff in study related matters.
• Obtain and maintain essential documentation in compliance with ICH-GCP, Procedural Documents and local regulations.
• Manage study supplies, drug supplies and drug accountability at study sites.
• Perform source data verification according to SDV plan.
• Ensure data query resolution.
• Work with data management to ensure quality of the study data.
• Ensure accurate and timely reporting of Serious Adverse Events.
• Share relevant information on patient recruitment and study site progress within local Study Team.
• Update VCV and other systems with data from centers as per required timelines.
• Prepare for activities associated with audits and regulatory inspections in liaison with local Study Team Lead and QA.

Clinical Research Associate II – CART

Clinical Operations

• Assists FSP Clinical Operations Management with activities in support of contracted services
• Conducts direct performance management of assigned staff to support Client FSP Clinical Operations activities
• May serve as a central Point of Contact (POC) between Senior Management and key Client personnel for contracted FSP Clinical Operations activities
• Manages program issues, including problem identification, resolution, and escalation
• Oversees onboarding and offboarding of staff, as applicable

Associate Manager, Clinical Operations

Business Operations

• The Business Operations Associate serves as the internal coordinator for the work order, contract modification, contract management, and purchase order processes.
• Works closely with the Director, Clinical Portfolio Services, Business Operations and key stakeholders to follow tight financial controls.
• Responsible for project management, and coordination required to drive the business to efficient and effective financial and resource management processes.
• In partnership with FP&A, Procurement, Suppliers and Clinical Operations, ensure accurate, transparent, and timely contract and purchase order creation to support Clinical Operations.
• Enter contracts, track POs, and change orders for Functional Service Provider (FSP) engagements.
• Provides support to Clinical Business Operations team with budget, forecast and long-term planning, generating variance analyses for projects, and decision-making and insights development of forecasting and scenario support (e.g., what-if analyses, budget impacts).
• Report generation such as, but not limited to, FTE reporting and financial variance reports.
• Contribute to continuous improvement and maintain a focus on value-add services relating to resource planning and financial planning.

Business Operations Associate

Administrative Assistant

• Serve as a trusted partner to senior leaders, anticipating needs and proactively managing priorities
• Act as an extension of leadership by ensuring seamless day-to-day operations and enabling focus on high-value work
• Build strong working relationships with executives, stakeholders, and cross-functional teams
• Own complex, high-volume executive calendars with full autonomy
• Proactively prioritize meeting requests, balancing competing demands and shifting priorities
• Review and triage inbox requests, synthesizing information and making scheduling recommendations
• Manage complex domestic and international travel arrangements, often involving multi-stop itineraries
• Anticipate travel needs and make informed logistical decisions aligned with business priorities
• Ensure seamless execution of travel plans, including contingency planning for changes
• Bring structure and clarity to fast-moving, often ambiguous situations
• Track deadlines, commitments, and deliverables to ensure nothing falls through the cracks
• Manage expense reporting and supporting documentation in a timely and accurate manner
• Support event and speaking engagement preparation, including coordination of logistics, materials, and deadlines
• Manage competing priorities across multiple leaders and stakeholders
• Adapt quickly to last-minute changes, proactively resolving conflicts and rescheduling as needed
• Apply sound judgment to make decisions independently while knowing when to escalate
• Leverage tools such as Outlook, Teams, and expense systems (e.g., Concur) to manage workflows effectively
• Embrace new technologies, including AI-enabled tools, to improve efficiency and streamline processes
• Identify opportunities to optimize processes and enhance team effectiveness

Senior Administrative Assistant

Events

• Develop and implement a comprehensive global strategy for external events that aligns with the organization's overarching objectives and growth goals.
• Plan, manage, and execute a portfolio of events, including customer-facing experiences, industry conferences and sponsorship initiatives.
• Develop events that have a clear creative narrative, that align and drive strategy; secure thought leadership opportunities and plenary experiences that give lift to the event narrative; support script development/process to fully connect the event experience and inspire participants.
• Create production flows and schedules; provide onsite management for general sessions at events to include set up, technical direction, rehearsals, tear down, and other oversight as needed.
• Identify key opportunities for global engagement through events, conferences, and partnerships.
• Act as a brand ambassador, ensuring all events reflect Parexel’s identity and strategic priorities.
• Oversee all aspects of event production, including venue selection, vendor management, logistics, and on-site coordination.
• Collaborate with senior leaders to identify and amplify key stories and messaging.
• Manage flawless execution of complex events.
• Plan and produce the worldwide events calendar.
• Define and track event KPIs to measure success, gather feedback, and identify areas for improvement.
• Provide post-event analysis, reports, and recommendations to stakeholders.
• Develop, manage, and optimize budgets for global events, negotiate contracts, ensure financial sustainability, high-quality event delivery and adherence to organizational standards.
• Analyze cost-effectiveness and ROI of events, making strategic recommendations for improvements.
• Deliver transparency reporting on financial excellence.
• Collaborate with internal departments to ensure that all activities are conducted in compliance with policies, procedures, and local regulatory/legal requirements, company policies, and code of conduct.
• Identify and mitigate potential risks associated with large-scale events.

Senior Director, Events

Affiliate Manager

• Responsible for site start-up, activation, relationship management, recruitment, and quality assurance
• Contributes to site selection and provides local intelligence
• Ensures site support and resolves issues
• Collaborates with various functions to optimize communication
• Maintains site quality and patient safety utilizing data analytics
• Supports Country Specific Activities for clinical trial implementation
• Deploys client site strategies by qualifying and activating assigned sites
• Reviews and assesses site qualification outputs for site selection
• Maintains knowledge of assigned protocols
• Conducts study start-up activities including Site Qualification
• Ensures follow up activities’ completion post Site Qualification visit
• Partners with the Clinical Research Associate for monitoring readiness
• Builds relationships and operational quality at the site

Site Care Partner – Oncology

Recruitment

• Accountable for the delivery of the recruitment strategy and tactics against the approved plan, timeline, and budget.
• Coordinate with other patient recruitment team members, the clinical study team, and other functional lines to ensure all patient recruitment deliverables are met.
• Provide oversight for vendors contracted to deliver patient recruitment and retention services.
• Monitor if recruitment strategies are meeting clinical trial enrollment and timeline goals, including country and site segmentation needs and enrollment of diverse and underrepresented populations.
• Proactively identify recruitment and retention risks, provide recommended mitigations, and oversee execution of contingency plans.
• Partner with other recruitment team members, the clinical study team, other internal stakeholders, and vendors to appropriately manage escalations and resolve issues.
• Support the delivery of innovative solutions for patient recruitment and retention.
• Lead study close-out activities including analysis of lessons learned and best practices.

Patient Recruitment Specialist

• 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
• Monitor and maintain compliance with ICH-GCP and applicable international and local regulations
• Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis
• Conduct on-site visits for Qualification and Initiation visits
• Generate visit/contact report
• Evaluate overall compliance and performance of sites and site staff
• Ensure that assigned sites are audit and inspection ready
• Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships

Senior Clinical Research Associate

• Effectively communicate with internal and external customers as well as third-party vendors; prioritize effectively and respond to urgent requests within the team or from the sponsor
• Oversee and/or manage study start-up activities as applicable
• Provide inputs to project tools and study plans
• Develop site selection and monitoring plans
• Ensure all team members have access to study systems, tools, and documents
• Identify, organize and deliver (where appropriate) study specific training in collaboration with Project Leader and Project Specialists
• Provide leadership and direction to project team members
• Monitor study timelines, patient recruitment, retention, and data cleaning to ensure successful outcome of the project
• Participate in sponsor, investigator and team meetings
• Collaborate with project team on database lock activities and ensure compliance with applicable guidelines and procedures

Clinical Operations Leader – PM

• Responsible for all site management and supervisory activities in assigned oncology studies
• Work with industry leaders and subject matter experts
• Mentor junior CRAs
• Use world-class technology
• Opportunities to travel, work from home, and play a key role in the drug development process