Parexel

Manager

• Act as a subject matter expert for the configuration, implementation, and execution of Central Monitoring RBQM system across studies
• Maintain Central Monitoring Key Risk Indicators and Quality Tolerance Limit Libraries within Central Monitoring RBQM system
• Coordinate with functional and cross functional stakeholders to develop configuration specifications for Central Monitoring in RBQM system
• Provide operational expertise, training, and guidance as a point of escalation
• Conduct central monitoring reviews in support of study central monitor
• Participate in ongoing improvements in standardizing technologies, systems, processes, and training materials

Manager, Central Monitoring, Data Analysis

Data Analyst

• Lead a large clinical study or a series of related studies with minimum guidance
• Represents Data Management on the CTWG for assigned studies
• Provide mentoring and training to lower-level Data Management staff assigned to your studies
• Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts
• Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design
• Be able to perform a thoroughly detailed review of eCRF data requirements
• Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines
• Lead the development of data edit check specifications and data listings
• Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards
• Able to resolve EDC system issues with team members
• Develop or lead the development of the Data Management Plan for a clinical study
• Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications
• Provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed
• Perform reconciliation of header data from external data sources against the clinical database
• Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
• Lead database upgrades/migrations including performing User Acceptance Testing
• Maintain study workbooks and data management files
• Perform database lock and freeze activities per company SOPs
• Participate in regular team meetings and provide input when appropriate
• Provide input into the development of data management SOPs, Work Instructions, and process documents; take a leadership role in the development of assigned documents
• Contribute to a professional working environment including the application of the sponsor’s Code of Business Conduct and Ethics
• Assist with the training of new employees and/or contractors

Senior Clinical Data Analyst – Phase I Experience Required

• Lead a large clinical study or a series of related studies with minimum guidance
• Represents Data Management on the CTWG for assigned studies
• Provide mentoring and training to lower-level Data Management staff assigned to your studies
• Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies
• Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design
• Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines
• Lead the development of data edit check specifications and data listings
• Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards
• Develop or lead the development of the Data Management Plan for a clinical study
• Perform database lock and freeze activities per company SOPs
• Provide input into the development of data management SOPs, Work Instructions, and process documents

Senior Clinical Data Analyst – FSP

• Lead the planning and oversight of clinical samples and external data sources for assigned studies, ensuring effective management of related procedures and deliverables, including: Understand trial-specific requirements for external data sources and logistics; advise on provider contracting.
• Develop Sample Management Plan and data transfer agreements; coordinate with third-party vendors on study documentation.
• Review and provide feedback on study documents (e.g., Clinical Monitoring Plans, informed consent forms).
• Support vendor system setup (e.g., labs, imaging).
• Ensure study team are informed of data flows and reconciliation requirements.
• Perform reconciliation between EDC and external data sources; provide sample shipping manifests where applicable.
• Proactively identify transfer/data issues, plus trends and provide proposals to remedy the in scope third party data/deliverables.
• Identify and resolve data transfer issues; monitor trends and recommend corrective actions.
• Assess risks to timelines for data deliverables; develop mitigation strategies and recommendations.
• Provide input into vendor budgets and change orders; support invoicing as needed.
• Maintain proactive communication with study team and external vendors regarding deliverables and status.
• Maintain study documentation in the eTMF.
• Coordinate closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management and Regulatory to ensure operational excellence on assigned product/program.
• Participate in regular Clinical Data Operations team meetings and provide input when appropriate.
• Contribute to or lead department process improvement initiatives which could include the development of data management SOPs, Work Instructions, and process documents.
• Onboard and/or train new employees and/or contractors.
• Maintain current professional knowledge of regulatory requirements and industry best practices in relevant areas of CDM, Third Party Vendors and related data sources/deliverables, technology advances and quality assurance.

Manager, Centralized Data and Sample Management

Software Engineer

• Work with Project Lead ADS to develop, validate, and maintain datasets and statistical outputs for clinical trials, including Study Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets, and tables, listings, and figures (TLFs), ensuring programming accuracy, traceability, and compliance with internal processes and regulatory expectations
• Develop and support programming outputs across a wide range of data types, including exploratory biomarker data and real-world data
• Collaborate on Exploratory Data Analyses (EDAs), enabling insight generation to inform drug development strategies and enhance scientific communication

Statistical Programmer II

Medical Director

• Lead Medical Excellence in Clinical Trials
• Serve as Medical Monitor for gastroenterology studies, ensuring scientific integrity and patient safety
• Provide expert medical oversight throughout the clinical trial lifecycle—from protocol development through study completion
• Review and approve critical study documents including protocols, Medical Monitoring Plans, safety reports, and Informed Consent Forms
• Conduct real-time medical data review, evaluate protocol deviations, and ensure medical accuracy across all study deliverables
• Build and maintain consultative relationships with pharmaceutical sponsors
• Deliver medical expertise during client meetings, bid pursuits, and proposal development
• Provide therapeutic area training to study teams and site personnel
• Respond to complex medical and protocol-related questions from sites and study teams
• Participate in early engagement activities and feasibility assessments
• Contribute medical insights to protocol design and drug development programs
• Support pharmacovigilance activities including medical review of serious adverse events
• Collaborate with cross-functional project teams and business development initiatives

Medical Director, Gastroenterology

Project Manager

• Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables.
• Develop and maintain a high-level global regulatory plan tracker.
• Serve as the project manager for meetings, ensuring productivity and effective materials management.
• Assist in the preparation of materials for health authority engagements.

Regulatory CMC Project Manager

Compliance

• Own the client relationship and communicate client expectations.
• Cooperate with Finance Business Partner for systems functionality.
• Lead kickoff meetings and set team expectations.
• Manage project budget and ensure quality standards are met.
• Oversee project closeout procedures and team management.

Regulatory Affairs Project Lead – MAAs

Financial Planning and Analysis

• Lead the monthly investigator payment forecast cycle and support project analysis requirements.
• Collaborate with clients and clinical team members to explain financial impact of clinical conduct.
• Manage variance analyses for projects and identify risks in project forecasts and budget.
• Present updates on financial status of investigator payments for assigned projects.

Investigator, Financial Analyst II

Consultant

• Contributes statistical capabilities and methodological leadership at all stages of projects, from planning to completion.
• Works with junior team members in designing, developing, and delivering client solutions across multiple projects
• Keeps up to date with the changing Access/HTA landscape and academic research to ensure current access trends and methodologies are incorporated into evidentiary plans
• Engages in ongoing thought leadership and innovation objectives in the field of advanced analytics

Health Economics Consultant – HTA Statistician, Network Meta-analysis

Full-stack Engineer

• Design, build, and manage CI/CD tools integration and operations, with full automation of CI/testing leveraging Azure DevOps.
• Develop and automate scalable Continuous Integration pipelines for efficient software delivery.
• Actively participate in the design and implementation of systems and tools across the cloud data stack, including Databricks, Azure Data Factory (ADF), and Azure DevOps.
• Build dashboards to monitor the health and performance of data pipelines and environments.
• Collaborate with internal development and QA teams to ensure end-to-end quality and reliability.
• Write and maintain infrastructure documentation for clarity and consistency.
• Troubleshoot and resolve issues along the CI/CD pipeline.
• Work directly with third-party vendors and infrastructure engineering teams to address and fix issues impacting the DevOps and Data ecosystems.

Software Engineer – AMS

Research Analyst

• Oversight of Monitoring Responsibilities and Study Conduct
• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock
• Serve as the primary point of contact for assigned investigator sites during study conduct
• Facilitate information flow between members of the study team, vendors and assigned investigator sites
• Perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol

Senior Clinical Research Associate II – FSP

Clinical Research

• Production and/or QC of derived datasets and both simple and advanced statistical outputs using efficient programming techniques
• Understand and apply moderately advanced statistical methods
• Coordinate and lead a project team to successful completion of a project within given timelines and budget
• Interact with clients as key contact with regard to statistical and contractual issues
• Assist in the production of analysis plans, statistical reports, and other process supporting documents
• Provide training in statistical analysis to internal clients
• Proactively participate in and/or lead process/quality improvement initiatives

Biostatistician II

• Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures;
• Perform programming validation to ensure quality of analysis datasets and programming outputs.
• Provide programming support for project teams, including development of programming strategies, standards, specifications, and programmed analysis.
• Support the electronic submission preparation and review.
• Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; assess impact on programming activities.
• Interact with vendors regarding project standards, programming conventions, programming specifications and file transfers.
• Provide leadership for ensuring quality of deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices.
• Identify opportunities for increased efficiency and consistency within team and our interactions with strategic vendors.
• Independently lead and / or perform programming assignments with minimal supervision.
• Support improvement initiatives.

Senior Statistical Programmer

• Oversee clinical trial protocols and monitor data quality
• Collaborate with cross-functional teams to ensure compliance
• Support project managers in delivering projects on time
• Provide regular updates and reports to stakeholders