Parexel

General

• Dirigir la estrategia de contratación de sitios de principio a fin y su ejecución para ensayos clínicos globales
• Actuar como el principal punto de contacto con los patrocinadores, incluido la asistencia a llamadas con patrocinadores a través de múltiples zonas horarias
• Supervisar y guiar los equipos de contratos de sitios asignados a proyectos, proporcionando liderazgo, dirección y apoyo

Site Contract Leader

Data Analyst

• Analyze scientific and operational data to support Data Surveillance process
• Review project-specific Quality Tolerance Limits
• Assist in developing Data Surveillance Plans (DSPs)
• Conduct defined project reviews
• Attend internal and external Data Surveillance meetings, presenting relevant findings to the project team
• Support the development of a robust Data Surveillance Plan
• Configure and maintain Data Surveillance technologies (e.g., CluePoints Central Monitoring Platform)
• Review relevant data to support reviews per the project specific Data Surveillance Plan
• Document findings from Data Surveillance activities
• Provide feedback and collaborate with technology teams
• Identify potential data quality trend, outliers and emergent issues
• Participate in Investigator and other external/internal meetings and audits & regulatory inspections
• Recognize impact of study non-compliance/issues/delays/data quality signals and communicate promptly

Data Surveillance Analyst

Associate

• 迅速に臨床試験が行えるように、ファンクショナルリーダーとして、施設との契約をリードする高度な専門職です。
• 治験契約に関する方針に従い、グローバルまたは日本での治験契約書ひな形の作成
• 治験にかかわる予算の算出、レビュー、治験施設契約担当者との交渉や、必要に応じて治験依頼者との会議に同席

Site Contracts Associate – 東京, 大阪

Medical writer

• Author clinical documents for regulatory submission
• Ensure document quality and adherence to guidelines
• Serve as primary client contact for medical writing projects
• Review and revise documents based on team feedback
• Manage timelines and mediate project-related issues

Medical Writer II

Manager

• Assist with developing, preparing, planning and execution of Patient Engagement activities
• Identify opportunities and execute initiatives to enhance Patient Centricity and build a patient-centric culture across OARS and Clinical Development & Operations
• Maintain and update Patient Engagement project management platforms to enable effective, timely and compliant PE across CD&O, as needed
• Track Patient Advocacy Group funding and engagements to ensure regular and timely communications, timely membership renewals, tracking of upcoming collaborations/events/activities as well as ensuring timely accomplishment of deliverables.
• Develop and manage new Patient Engagement Newsletter
• Assist in identifying opportunities to establish trusted relationships in diverse and underrepresented patient communities to pave the way for enhanced engagement of diverse patient populations to advance scientific and clinical development programs and improve health equity.
• Assisting with project management support for priority projects (eg: Framework project, Project 707)
• Manage Insight Committee including but not limited to the contracting, facilitation and onboarding of new InSight Committee members
• Support CTD & PE Ways of working (eg: reorganize CTD&PE Teams channel to improve accessibility and collaboration, Improve SharePoint layout and content to improve usability and awareness of team’s capabilities (in progress)
• Updating PAL activity tracker
• Supporting, leading and/or managing other key activities in support of the Clinical Trial Development & Patient Engagement Team, where needed

Patient Engagement Manager

Clinical Research

• Supervise, advise and review: Leverage your expertise.
• Develop complex analysis strategies and execute them using efficient programming techniques (software: SAS, R).
• Foster teamwork.
• Perform intricate statistical analyses and provide input to statistical reports.
• Share knowledge.
• Provide input to analysis plans, statistical reports, statistical sections of integrated clinical reports.
• Be a proactive advisor for all types of analysis from the proposal process through the project life cycle.
• Review analysis data sets and quality control all types of statistical analysis deliverables.
• Coach and mentor. Train and uplift junior members of the department.
• Liaise with other biostatistical and company departments to optimize global efficiency.

Senior Biostatistician

Compliance

• Lead end-to-end CTA project management across multiple studies and countries
• Plan, track, and deliver submissions aligned with timelines and regulatory requirements
• Manage risks, dependencies, and complexities in global regulatory environments
• Apply knowledge of EU CTR and ROW CTA requirements
• Manage core clinical and regulatory documentation
• Collaborate with cross-functional global teams
• Build and maintain stakeholder relationships and resolve conflicts
• Monitor KPIs related to timelines and deliverable quality
• Identify risks and lead quality investigations as needed

Regulatory Affairs Associate

• Provide high-quality, timely, scientific/strategic solutions to meet client needs.
• Understand client objectives and develop evidence delivery using innovative strategies.
• Lead conduct and analysis of research to shape strategic recommendations under guidance of Project Director.
• Execute SLR tasks: screening, data extraction, protocol design, quantitative feasibility.
• Prepare synthesis and review of findings.
• Develop SLR deliverables: reports, slide decks, manuscripts, abstracts, posters.
• Produce quality work aligned with expectations of Project Lead/Manager and clients.
• Work within broad project guidelines under Project Director/Technical SMEs.
• Take initiative to prioritize work while aligning with Project Lead and Line Manager.
• Follow and implement organization’s consulting models and methodologies.
• Identify internal/project issues, escalate with proposed solutions.

Health Economics Associate

Research Analyst

• Act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites
• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial
• Gains an in-depth understanding of the study protocol and related procedures
• Performs clinical study site management/monitoring activities in compliance with ICH/GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated Documents
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance

Clinical Research Associate, CRA

• Act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial
• Performs clinical study site management/monitoring activities in compliance with International Conference on Harmonization / Good Clinical Practices, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated Documents
• Gains an in-depth understanding of the study protocol and related procedures
• Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready
• Participates and provides inputs on site selection and validation activities
• Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased; Subjects’ right, safety and well-being are protected
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance
• Identifies, assesses, and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with Clinical Research Manager and Partner Line Manager
• Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines
• Contributes to CRA team knowledge by acting as process Subject Matter Expert, buddy/mentor and sharing best practices as appropriate/required
• Supports and/or leads audits/inspection activities as needed
• Performs co-monitoring visits where appropriate

Clinical Research Associate – Oncology

Data Scientist

• Provides technical expertise across all aspects of Data Management
• Serves as the primary Data Management point of contact for assigned studies
• Ensures contracted Data Management deliverables are met with a focus on quality and timeliness
• Manages study data delivery timelines, including Go-Live, Interim Deliveries, and Final Database Lock
• Collaborates closely with cross-functional teams across global geographies
• May provide mentorship to Assistant Data Managers and Data Management peers
• Reviews and analyzes study metrics to identify trends and summarize study health
• Reviews agreements to manage sponsor-specific metrics and performance indicators
• Attends cross-functional meetings and prepares meeting minutes and action logs
• Ensures compliance with Standard Operating Procedures and ICH/GCP guidelines
• Identifies quality issues, ensuring appropriate resolution and closure.
• Participates in internal, sponsor, and regulatory audits and inspections.

Data Management Lead

QA Engineer

• Lead, Perform and Report audits
• Manage GxP audits
• Collect and review responses to audit findings
• Act as point of consultancy for Operations and Quality with regards to the implementation of adequate CAPAs
• Lead and coordinate internal audit programs
• Arrange meetings with client and other key stakeholders as required
• Develop and optimize new and existing processes to maintain and improve quality

Senior Technology Auditor, QA

Principal

• Draft, review and negotiate site agreements including clinical study agreements, service agreements, and team member agreements
• Provide context to comments received from sites based on legal and business framework
• Manage the contract execution process
• Develop and maintain positive relationships with clinical trial sites
• Track and report on the statuses of site contracting activities

Principal Site Contracts Associate

• Support the execution of Parexel Quality's strategy and Parexel's QMS.
• Support execution of the strategic and tactical goals of QMSO for the key QMS elements.
• Work to continuously improve Parexel’s QMS.
• Maintain a familiarity with Parexel QMS-related systems.
• Provide coaching, mentoring and constructive feedback to QMSO staff as required.
• Manage projects and initiatives as assigned, including participants, reporting and escalations as needed.
• Support management of the QMSO budget.
• Support Corporate Quality in the attendance, preparation for and follow up of internal/external audits and inspections.
• Work with Corporate Quality to develop and/or update quality/process documents, tools, and templates.
• Provide technical knowledge and oversight and serve as an escalation point where appropriate.
• Maintain a positive, results oriented work environment.
• Present QMS to clients, auditors and regulatory inspectors.
• Lead cross functional improvements projects as required.

Quality Management System Lead

Data Engineer

• Lead and implement Data Receipt Agreements with vendors through cross-functional collaboration
• Program and configure import procedures for data ingestion using SAS, Workbench, or alternative technologies
• Design and execute reconciliation checks to ensure accurate data transfer
• Program offline listings and custom reports to provide actionable insights
• Aggregate data across multiple sources and manage external data effectively
• Handle missing values, raw data files, data structures, and SAS dataset operations
• Review and analyze data outputs to provide insights to study teams and clients
• Ensure first-time quality on all deliverables
• Manage electronic data timelines and coordinate with project teams
• Lead programming teams to successful study completion within timelines and budget
• Deploy and manage data management technology (Workbench, SAS, R, etc.)
• Maintain comprehensive study documentation in accordance with SOPs, guidelines, and work instructions
• Ensure traceability and regulatory compliance across all activities
• Document deviations and communicate them to project teams
• Participate in creating standards through tools (SAS macros, libraries, processes)
• Develop and implement project-specific tools and templates
• Improve efficiencies through standardized project structures and naming conventions
• Support business development and bid defense meetings