Parexel

Clinical Trial Associate

• Provide logistical support to one or more global study management teams through all phases of clinical study management
• Develop and maintain relationships with study management team members, affiliate teams, and vendors
• Assist the Clinical Trial Manager with communication between the study management team and affiliates
• Coordinate global study supplies using designated systems
• Coordinate and organize study-related meetings and develop presentation materials
• Consolidate study information for trackers and databases
• Support protocol feasibility, country, and site selection processes
• Support technical and logistical study processes
• Track and maintain study information and documentation and report study progress
• Maintain study management data, team contact details, country contacts, and distribution lists
• Track Health Authority, IRB, and IEC submissions and approvals in CTMS; identify delays and escalate issues
• Provide submission and supplementary documentation to affiliates or Product Development Regulatory
• Maintain completeness of the study-level Trial Master File under CTM direction
• Identify and contribute to best practices and process improvements
• Incorporate learnings and recommendations from study debriefs and best practices

Senior Clinical Trial Associate

Compliance

• 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 processes
• Review study reports and quality documentation from manufacturing and quality control departments to ensure compliance with regulatory requirements
• Coordinate submission preparation with manufacturing, supply chain, quality control, quality assurance, and other regulatory departments
• Write and review submission content related to variations and responses to health authority questions
• Manage projects within Regulatory Information Management systems, ensuring the maintenance and accuracy of worldwide submissions
• Identify, escalate, and mitigate risks associated with regulatory procedures and activities across global markets
• Support post-approval regulatory activities and contribute to regulatory operations from submission planning through approval and market expansion
• Collaborate with cross-functional teams including manufacturing, quality, and supply chain partners

Regulatory Affairs Consultant – CMC Biologics, Plasma Products

Clinical Research

• Manage integration of project team activities
• Manage strategic study operations, including study sites, regulatory submissions, drug supply and use, subject enrollment, regulatory document flow, study timelines, budgets, financial information, performance metrics, and data flow
• Provide input on trial-level operational strategies from protocol design through the final clinical study report
• Provide input into global subject/patient recruitment plans
• Manage CRO and vendor identification and day-to-day operational activities, including setup, statement of work creation, and budget oversight
• Create and update critical trial-specific documents
• Support development of compound- and protocol-level training materials
• Review and provide input into budgets, timelines, and forecasts for assigned clinical studies
• Support trial-level inspection readiness activities, including risk identification and mitigation plans
• Participate in trial- and department-level process improvement activities
• Manage relationships between study sites and vendors
• Interface with internal key stakeholders
• Support onboarding of new team members
• Attend stakeholder meetings and provide operational updates and input

Clinical Trial Manager

• Lead cross-functional trial teams and execute end-to-end clinical trial delivery
• Build and deliver trial operational plans
• Oversee trial delivery, budgets, timelines, quality, milestones, and protocol deviation resolution pathways
• Identify, set up, and oversee CROs/vendors, statements of work, budgets, KPIs, and performance
• Ensure trial deliverables and milestones meet corporate and study-level goals
• Identify risks and implement mitigations and contingencies
• Ensure compliance with global health authority regulations, guidelines, and internal procedures
• Participate in Health Authority Inspections and internal QA audits
• Maintain inspection readiness and collaborate with R&D Quality on quality oversight
• Participate in trial- and department-level process improvement activities
• Mentor and support onboarding of new team members, particularly in Study Management
• Liaise with Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, and Medical Affairs
• Analyze budget variance and notify Finance of projected cost over/under expenditure
• Support and provide input into internal governance presentations and updates

Senior Manager, Clinical Trial Management – FSP

• Assist with organizing, updating and maintaining tracking systems and tools to support the conduct of clinical study from start-up to closeout
• Assist with the coordination and development of study management tools, monitoring tools, study manuals and training materials and presentations
• Schedule meetings, prepare and distribute meeting agendas, minutes, and follow-up action items for study teams
• Set up, organize and maintain study files and shared spaces in accordance with study requirements
• Coordinate and track study training
• Manage study sample and supply tracking and support interactions with vendors as needed
• Support the Study Management team with specific projects
• Communicate with study team members and identify and address study-related issues in collaboration with the study team
• Perform routine quality checks on trial-level documents to ensure completeness and accuracy
• Support timely, complete and compliant archiving in the TMF
• Participate in company, departmental and project team meetings, including Investigator Meetings
• Assist with basic financial and budget tracking activities related to the clinical trial

Clinical Trial Associate, Senior Project Specialist

Affiliate Manager

• Serve as a crucial liaison for investigative sites throughout a study's lifecycle
• Qualify and activate assigned sites and deploy client site strategies
• Support country and site selection activities, including site list review and site qualification
• Provide country/regional input on protocol feasibility, standard of care, and medical practices
• Conduct site start-up activities, including site qualification, activation checklists, ICF finalization, and SIV as applicable
• Coordinate site initiation training and complete documentation and systems required for activation
• Ensure follow-up completion after site qualification visits and SIV to prepare sites for FSFV
• Partner with CRAs to ensure site monitoring readiness and enrollment delivery
• Build and maintain relationships with site organizations, strategic partners, investigators, and site staff
• Coordinate communications and resolution of escalated site issues, including vendor, contract, and payment issues
• Manage investigational product and ancillary supply strategies and country requirements
• Support recruitment planning and delivery consistent with global, country, and local targets
• Partner with regulatory authorities and study start-up teams to complete country/local registries
• Provide site recommendations and local intelligence based on country, site, process, and performance knowledge
• Support study management with local import/export requirements for investigational products and supplies
• Review site reports and related issues
• Assure quality and consistency in monitoring delivery
• Support CRA-investigator relationships and escalate training or compliance concerns
• Complete required training, timesheets, expense reports, and CV updates
• Comply with Parexel processes, ICH-GCPs, and applicable requirements

Site Care Partner – Lead CRA

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP), applicable prevailing laws, GCP, and the Sponsor's standards
• Manage operational aspects of clinical trial activities at assigned investigator sites from site activation through database lock
• Serve as primary point of contact for assigned investigator sites
• Facilitate information flow between study team members, vendors, and investigator sites
• Perform investigator site development, coaching, and training of site personnel
• Provide protocol training and address protocol-related questions
• Support investigator meetings, enrollment, site activation, recruitment initiatives, and recruitment issue resolution
• Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring, and site closure
• Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit
• Submit required reports, documentation, updates, and tracking, including TMF documentation, site reports, protocol deviations, recruitment, clinical supply management, study progress, and metrics
• Identify and resolve investigator site issues and develop corrective and preventative actions
• Resolve data queries and conduct investigator site close-out activities
• Oversee investigational product receipt, handling, accounting, storage, and destruction
• Support database release as needed
• Maintain understanding of the product, protocol, and therapy area
• Support patient safety, eligibility, and clinical guidance to investigators
• Drive Quality Event remediation and audit CAPA activities when applicable

Clinical Research Associate II/Sr. Clinical Research Associate

Clinical Trial Coordinator

• Support Clinical Research Managers and study team members throughout the clinical trial lifecycle from study start-up to study closure
• Provide trial and site administration and operational support
• Collaborate with finance and budgeting representatives on study-related financial activities
• Coordinate and support study meeting planning activities
• Interact with internal and external stakeholders, including study sites and vendors, to support clinical study objectives
• Track and report negotiation activities related to study operations
• Ensure compliance with applicable financial procedures
• Maintain study tracking tools and systems
• Collate, distribute, and archive clinical trial documentation
• Assist with electronic Trial Master File reconciliation activities
• Support budgeting, agreement, and payment processes with relevant stakeholders

Clinical Trial Coordinator – FSP

• Ensure compliance with study protocols, ICH-GCP guidelines, regulatory requirements, and company procedures across assigned sites
• Evaluate site performance and recommend site-specific actions, escalating significant issues and supporting corrective action plans
• Verify informed consent processes are appropriately conducted and documented
• Assess patient safety and clinical data integrity by identifying protocol deviations, violations, pharmacovigilance concerns, and site-level risks
• Conduct remote and on-site monitoring according to the Clinical Monitoring Plan and Study Monitoring Plan
• Perform source document review and verification for accurate, complete clinical data
• Manage protocol deviation reporting, follow-up activities, and resolution of data queries
• Review investigational product accountability, storage, security, dispensing, administration, reconciliation, and documentation
• Document monitoring findings and study activities through monitoring reports, follow-up letters, communication logs, and required study documentation
• Ensure appropriately trained and delegated site personnel perform study activities
• Maintain tracking of observations, action items, site status, and study progress
• Review essential study records to maintain inspection readiness
• Participate in investigator, sponsor, monitoring, and project team meetings
• Collaborate with the primary Site Manager and stakeholders to support study objectives, deliverables, and timelines

Senior Clinical Research Associate – Oncology

• Manage investigator site relationships and assigned clinical trial sites
• Conduct site initiation, routine monitoring, remote/electronic monitoring, and site close-out activities
• Ensure clinical trials comply with monitoring plans, applicable laws, GCP, SOPs, and sponsor standards
• Serve as primary contact for assigned investigator sites and coordinate with study teams, vendors, and Site Care Partners
• Provide site personnel coaching, training, protocol training, and recruitment support
• Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit
• Submit Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment updates, supply management records, study progress, and metrics
• Identify and resolve site issues, including corrective and preventive actions
• Resolve data queries and support database release
• Oversee investigational product receipt, handling, accounting, storage, and destruction
• Support patient safety, eligibility, clinical guidance, quality event remediation, audits, and CAPA activities
• May undertake unblinded monitor responsibilities where appropriate

Clinical Research Associate II/Senior Clinical Research Associate

• Lead end-to-end performance and project management of assigned clinical trial protocols
• Manage study start-up activities, including site selection strategies, monitoring plans, and trial planning tools
• Review and contribute to patient recruitment and retention strategies
• Provide leadership, guidance, and direction to project team members across multiple locations and functions
• Evaluate project resource requirements and monitor resource utilization throughout the study lifecycle
• Address and resolve site issues, escalating risks and ensuring timely closure
• Monitor study timelines, patient recruitment, retention, and data cleaning activities
• Maintain oversight of quality standards and follow up on quality-related issues
• Drive process improvements to enhance study efficiency and operational performance
• Contribute to revenue recognition forecasting and project planning activities
• Collaborate on database lock activities and study close-out deliverables
• Ensure completion of administrative close-out procedures, study archiving, and client documentation requirements
• Manage complex oncology clinical trials for a pharmaceutical client
• Ensure compliance with ICH-GCP, local regulations, client requirements, and quality standards

Clinical Research Manager – Local Trial Manager

• Coordinate the design, planning, and execution of early-phase clinical trials with the Clinical Director and internal/external team members
• Oversee trials within and/or across programs or therapeutic areas
• Ensure excellence in execution and compliance to support study objectives and data validity
• Manage internal and external team performance to achieve project objectives
• Resolve project performance issues
• Ensure appropriate clinical safety assessment and risk management of compounds
• Conduct real-time oversight of ongoing trials to identify and mitigate patient, study design, data, or study conduct issues
• Review and interpret clinical trial data
• Potentially conduct on-site study monitoring, including site training and supervision of complex, novel endpoint/biomarker collection processes
• Apply knowledge of GCP, ICH guidelines, and regulatory requirements for clinical development
• Co-author clinical sections of protocols, clinical investigator brochures, and clinical study reports
• Develop study operational documents, including site monitoring plans, study operations manuals, and informed consents
• Manage trial and program projects, team activities, risk assessment, and contingency planning under accelerated timelines
• Build knowledge and skills to manage additional early drug development processes and procedures

Early Clinical Scientist – Translational Medicine

Software Engineer

• Provide technical expertise for the conduct of clinical trials
• Support programming activities related to the analysis and reporting of clinical study data with minimal supervision
• Potentially fill the Statistical Programming Lead role, or part of it, on small, non-complex projects
• Deliver high-quality service using client systems and following client processes
• Work closely with client teams and Parexel colleagues in a global environment
• Produce derived datasets, including SDTM and ADaM, tables, figures, and data listings of any complexity
• Quality-control low-medium complexity derived datasets, tables, figures, and data listings
• Develop and QC derived dataset specifications and other process-supporting documents
• Maintain complete traceability and regulatory compliance
• Participate in and contribute to programming community knowledge-sharing sessions

Statistical Programmer II – FSP

Data Analyst

• Perform clinical data validation activities on assigned projects with minimal guidance and supervision
• Support data validation activities, Data Management documents and data cleaning matrices
• Perform or lead data validation, cleaning, review and reconciliation activities during study conduct and database lock
• Manage queries, review manual/SAS listings and reconcile external vendor data
• Perform or support setup of Data Management documents and ensure proper documentation
• Lead or perform user acceptance testing on clinical database setups
• Review protocols and EDC entry screens when required
• Provide input on data management timelines and coordinate operational activities during database setup
• Track and review CRFs and support data entry where required
• Ensure compliance with SOPs, ICH/GCP Guidelines and applicable requirements
• Perform or lead functional quality-control activities on databases and patient data
• Maintain training compliance and address identified training needs
• Provide on-the-job training to staff and project teams
• Mentor other clinical data analysts
• Act as a process lead for a specific data validation activity when assigned

Clinical Data Analyst II

• Monitor and manage clinical sites in compliance with CFR and ICH/GCP guidelines
• Evaluate, initiate, monitor, and close clinical sites
• Identify and qualify potential investigators
• Perform pre-study, site initiation, interim monitoring, and close-out visits
• Assist with site start-up, essential document review, and collection
• Train investigators and site staff on protocols, procedures, documentation, and regulatory requirements
• Monitor protocol and GCP compliance
• Perform source data review and verify clinical data against source documents
• Ensure timely data entry and query resolution
• Perform drug accountability and ensure adequate drug supply
• Review research specimen documentation, storage, processing, and shipment
• Collaborate with drug safety on serious adverse event reporting
• Maintain complete and accurate site regulatory files and monitor IRB compliance
• Track and report study progress, protocol variations, issue resolution, and follow-up compliance
• Prepare visit reports, confirmation letters, and follow-up letters
• Maintain the Clinical Trial Management System (CTMS)
• Resolve site issues and action items or escalate them per the Clinical Monitoring Plan
• Assist Data Management and provide co-monitoring support
• Contribute to quality audits, department initiatives, study documents, and vendor management or data review activities
• Attend required staff meetings and training
• Complete required training, timesheets, expense reports, and CV updates