Parexel

Data Analyst

• Design, deliver, and maintain interactive, study-level data visualizations that support Medical Data Review (MDR) and safety signal detection
• Create standardized yet customizable data visualization templates and provide study teams with high-impact graphical tools
• Serve as a partner and point of support for clinical scientists, offering training and ongoing consultation
• Ensure effective use of visual analytics in study workflows
• Ensure visual analytics are aligned with Risk-Based Quality Management (RBQM) principles
• Support documentation and quality control of visualization deliverables to ensure traceability and compliance

Real-time Visual Analytics Specialist

Research Analyst

• Contributes to the selection of potential investigators.
• Responsible for study start-up and regulatory maintenance, including submissions to EC/IRB and Regulatory Authorities.
• Trains and advises investigators and site staff in study related matters.
• Ensures sites are inspection ready and maintains regular communication with study teams.
• Initiates, monitors and closes study sites as per compliance.
• Conducts monitoring visits, remote data checks, and Quality Risk Assessments during the study.
• Ensures accurate and timely reporting of Serious Adverse Events.

Senior Clinical Research Associate

Manager

• Overall accountability for the entire Request for Proposals (RFP) process from receipt to delivery
• Analyze RFP documentation including study protocols and assign appropriate Subject Matter Experts (SMEs)
• Facilitate proposal development by coordinating strategic and operational areas while ensuring adherence to the Decisions Right policy
• Prepare and modify strategic proposals and budgets based on SME feedback and client requirements
• Manage the RFP process, identifying potential barriers and implementing effective mitigation strategies
• Obtain third-party quotes as needed and ensure alignment with RFP specifications and client communications
• Maintain accurate documentation in appropriate systems for metrics and KPI tracking
• Overall management responsibility for contract processes across specific or varied accounts
• Coordinate with Operations, Project Management, Legal, Business Development, and Finance to prepare, review, and negotiate contracts
• Develop account-specific contract standards including budget presentation, payment terms, and standard language
• Create, negotiate, and finalize contracts in accordance with departmental SOPs and guidance
• Amend project budgets in partnership with project and functional teams
• Develop contract strategies and delivery plans with clear accountability and timelines
• Proactively lead and facilitate client meetings to negotiate costs and terms
• Identify and manage contractual issues requiring input from finance, tax, or other internal stakeholders
• Ensure quality deliverables meet strict deadlines with proper rationale for cost changes

Proposals and Contracts Manager

Compliance

• CMC authoring for pharmaceutical products in medical imaging
• Author the CMC part of dossiers and manage worldwide submissions
• Delivery of regulatory submissions and prepare responses to health authority questions

Senior Regulatory Affairs Associate – Diagnostic Imaging, Interventional Radiology

Clinical Operations

• Strategic leadership of GCO Quality Management
• Collaborate with GCO leadership to develop and implement the strategy and direction for the GCO QM team
• Execute GCO QM mission and vision, including oversight of Global Support Centers
• Propose, lead, and implement GCO QM initiatives aligned with GCO priorities
• Provide end-to-end oversight of quality issue management including triage, severity, categorization, RCA, and closure
• Conduct trend analysis of GCO quality issues and audit findings
• Support audit and inspection preparation and execution
• Oversee planning, conduct, and reporting of site assessments

Director, Global Clinical Operations – Quality Management

• Provide GCP compliance support to clinical study teams under the direction of the Sr. Manager or the Associate Director
• Act as a Clinical Compliance member of clinical study teams for relevant Therapeutic Areas
• Develop strong relationships with R&D personnel across functions and teams providing coaching and compliance guidance as needed
• Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity to identify priority studies, compliance metrics for tracking, high-risk vendors, and key compliance activities (i.e., protocol review, vendor evaluations, inspection readiness)
• Identify and escalate significant quality and compliance issues to the Head of Clinical Quality & Compliance and relevant leadership, including the assessment of serious breaches
• Participate as a member of Contract Research Organization (CRO)/Vendor governance teams for assigned Therapeutic Areas/Studies.
• Establish a relationship with CRO Quality Team members for the ongoing review of quality and compliance issues
• Participate in vendor evaluations as a Subject Matter Expert (SME) as needed
• Support clinical teams/functions in drafting responses and CAPAs to internal and external audit findings
• Provide support and guidance for Quality Management System activities including self-reporting deviations, root cause analysis, and CAPA plan development and evaluation
• Identify and anticipate trends in quality issues and collaborate with functional management to ensure risk-managed solutions are implemented in a timely fashion
• Lead/manage inspection readiness activities and ensure project teams are trained and prepared for regulatory inspections.

Clinical Compliance Manager

• Provide quality leadership and direction to sponsor R&D stakeholders on GCP-related activities/issues and act as GCP expert/consultant for R&D colleagues.
• Act as a Clinical Compliance member of clinical study teams for relevant Therapeutic Areas.
• Develop strong relationships with R&D personnel across functions and teams providing coaching and compliance guidance as needed.
• Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity to identify priority studies, compliance metrics for tracking, high-risk vendors, and key compliance activities (i.e., protocol review, vendor evaluations, inspection readiness).
• Identify and escalate significant quality and compliance issues to the Head of Clinical Quality & Compliance and relevant leadership, including the assessment of serious breaches.
• Participate as a member of Contract Research Organization (CRO)/Vendor governance teams for assigned Therapeutic Areas/Studies.
• Establish a relationship with CRO Quality Team members for the ongoing review of quality and compliance issues.
• Participate in vendor evaluations as a Subject Matter Expert (SME) as needed.
• Support clinical teams/functions in drafting responses and CAPAs to internal and external audit findings.
• Provide support and guidance for sponsor Quality Management System activities including self-reporting deviations, root cause analysis, and CAPA plan development and evaluation.
• Identify and anticipate trends in quality issues and collaborate with functional management to ensure risk-managed solutions are implemented in a timely fashion.
• Maintain a high level of expertise in international GCP regulations and internal Policies and Procedures that may impact drug development.
• Provide support and guidance during and following internal audits and external regulatory inspections (as required).
• Provide expertise and consultative guidance on business initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial conduct and/or regulated drug development activities.
• Lead / manage inspection readiness activities and ensure project teams are trained and prepared for regulatory inspections.

Clinical Compliance Manager – FSP

Analyst

• The Investigator Contracts Lead (ICL) is responsible for direct site facing contract and budget negotiations through contract execution with assigned clinical investigator sites including initial agreements and amendments and oversight of other contracting professionals on assigned studies
• This also includes managing the Per-Subject Cost (PSC) process for assigned studies, managing escalation and resolution for budget and non-legal term issues from other ICL or preferred Contract Research Organizations (pCRO) and collaborating with other lines to plan site contracting timelines though start up.
• Exercise good judgment in balancing the risks to the sponsor in making budget and contractual decisions against the impacts to client clinical trial timelines.
• Follow processes to develop, negotiate, track, and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trials.
• Work with partners to develop and oversee the global site budget process.
• Work with clinical trial sites and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parameters.
• Lead study level site contracting activities and act as primary study point of contact for site contracting issues and timelines on assigned studies.
• Partner with Legal and other divisions to manage escalations in the site budgeting and contracting space.
• Partner with Legal, Finance, pCRO and other divisions to identify and implement areas of improvement in the site contracting space.
• Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface.

Investigator Contracts Lead, Contracts & Budgets Analyst

Operations

• Responsible for study, regional or specific country level activities from study startup through conduct and study close.
• Responsible for study management aspects of assigned studies, including vendor and budget management.
• Regional/Country/Study level implementation of Startup and Site Activation Plans.
• Responsible for regional/country/study level Recruitment Strategy.
• Support the development of study level plans.
• Communication with the local team and internal stakeholders and CRO partner to ensure efficient and timely study delivery.
• Responsible for study and/or country vendor management and oversight.

Country Study Operations Manager I

Data Scientist

• Responsible for acquiring, processing, and reviewing patient data
• Organizing clinical data forms, implementing data management plans
• Data management POC for DMTI and clinical studies
• Develop, implement, and conduct data quality checks as needed for work/studies
• Ensure collection, organization, curation, storage and safeguarding of patient data
• Track emerging study data and works closely with data science team
• Responsible for maintaining, updating, and organizing data transfer specifications across studies

Data Manager – FSP

Software Engineer

• Provide technical expertise for the conduct of clinical trials.
• Support various programming activities related to the analysis and reporting of clinical study data.
• Deliver best value and high-quality service working on client system and following client processes.
• Work closely with client teams and Parexel colleagues in global environment.
• Specialize in one of the following therapeutic area: hematology/oncology/cell therapy.
• Use SAS programming to produce derived datasets (ADaM), tables, figures, and data listings of varying complexity.
• Develop and QC derived dataset specifications and other process supporting documents.
• Ensure all work maintains complete traceability and regulatory compliance.
• Participate and contribute to knowledge-sharing sessions with programming community.

Statistical Programmer I – FSP

Affiliate Manager

• Deploys Global Site and Study Operations (GSSO) site strategies by qualifying and activating assigned site
• Supports processes to optimize country and site selection activities
• Collaborates with key stakeholders providing country/regional level input
• Maintains a knowledge of assigned protocols
• Conducts study start-up activities at the site level
• Ensures all site initiation activity including training per site activation checklist
• Partners with Clinical Research Associate (CRA) to ensure site monitoring readiness
• Responsible for relationship building and operational quality of the site
• Provides study support on escalated site issues

Site Care Partner I – FSP

• Provides operational leadership throughout the study lifecycle
• Leads and coordinates 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
• Provides quality oversight and coordination of regional and country operations
• Reviews consolidated pre-trial assessment (PTA) reports and feasibility outputs
• Ensures overall vendor oversight for vendors managed by SOMs
• Accountable for study management and oversight of all study management functions
• Develops and provides key inputs to clinical trial budget
• Ensures timely study closure and release of internal and external resources as appropriate if assigned to study post database lock
• Serves as technical expert for study management systems and processes

Global Study Manager II

• Deliver best value and high-quality service working on client system and following client processes
• Work closely with client teams and Parexel colleagues in global environment
• Specialize in one of the following therapeutic area: hematology/oncology/cell therapy
• Use SAS programming to produce derived datasets (ADaM), tables, figures, and data listings of varying complexity
• Develop and QC derived dataset specifications and other process supporting documents
• Ensure all work maintains complete traceability and regulatory compliance
• Participate and contribute to knowledge-sharing sessions with programming community