Worldwide Clinical Trials

Director

• Develop and implement an enterprise-wide resource optimization strategy and playbook focused on labor efficiency, productivity improvement, and global delivery optimization
• Establish scalable methodologies, frameworks, and best practices that improve workforce effectiveness and operational performance
• Identify, evaluate, and prioritize opportunities to optimize capacity, improve resource alignment, and enhance delivery outcomes
• Leverage data, automation, technology, and AI-enabled solutions to advance resource optimization initiatives and drive business value
• Build and manage financial models that size opportunities, establish targets, and measure productivity gains, cost avoidance, and realized value
• Partner with Finance and Human Resources to validate assumptions, track benefits realization, and quantify business impact
• Drive the development of dashboards and reporting tools that provide visibility into initiative progress, key metrics, and outcomes
• Lead cross-functional execution by aligning stakeholders, removing barriers, accelerating implementation, and driving accountability for results
• Facilitate enterprise-wide communication and coordination to ensure successful delivery of strategic transformation initiatives

Director, EPMO Resource Optimization – North America, Europe

Associate

• Arrange and track system access for project team, including Project Managers, Lead CRAs, and CRAs
• Maintain and quality audit project portals to assure the most recent document revisions are available
• Assist the project team with preparation and shipment of clinical trial documentation, including the Investigator Site File
• Maintain version and quality control of project documentation and submit it to the trial master file
• Track and maintain project-related information, including the site medical question and answer log
• Provide administrative and project tracking support to the clinical project team
• Ensure tasks for assigned projects with Project Delivery services are performed timely and accurately

Clinical Trials Associate

Data Analyst

• Collect and analyze site and patient enrollment actuals and forecasts with Central Planning and Clinical Operations teams
• Develop, maintain, and continuously improve forecasting models used outside of Medidata Payments
• Integrate forecasting data and processes with Medidata Payments forecasts
• Partner with Revenue Recognition teams to align forecasting with audit and financial reporting requirements
• Create accurate, client-ready forecast deliverables according to sponsor contractual requirements
• Analyze forecast performance through plan-versus-actual results and budget variances
• Communicate over-forecast and under-forecast risks to Project Analysts and Global Project Leads
• Support audit activities, change order processes, and study closeout reconciliations
• Prepare final forecasting and reconciliation reports for client delivery and project review

Grants Payments Data Analyst

Recruitment

• Lead and continuously enhance global recruitment strategies and processes to support evolving business needs
• Manage, coach, and develop a team of recruiting professionals, ensuring high performance and effective delivery
• Partner with HR Business Partners and hiring managers to anticipate workforce needs and deliver proactive recruitment solutions
• Advise stakeholders on creative and effective talent attraction, sourcing, and selection strategies
• Analyze recruitment data, performance metrics, and market trends to identify opportunities for continuous improvement
• Champion a consistent, positive, and high-quality candidate experience across all stages of the hiring process
• Personally lead recruitment efforts for senior-level and business-critical positions, including sourcing, screening, and offer management
• Serve as the owner of recruitment systems, ensuring tools and processes remain effective, current, and aligned with business requirements
• Build and manage strategic relationships with external recruitment partners and service providers
• Mentor and develop recruiting professionals and strengthen external partnerships

Manager, Talent Acquisition – Contract

• Develop and implement an enterprise-wide resource optimization strategy and playbook focused on labor efficiency, productivity improvement, and global delivery optimization
• Establish scalable methodologies, frameworks, and best practices to improve workforce effectiveness and operational performance
• Identify, evaluate, and prioritize opportunities to optimize capacity, improve resource alignment, and enhance delivery outcomes
• Leverage data, automation, technology, and AI-enabled solutions to advance resource optimization initiatives and drive business value
• Build and manage financial models that size opportunities, establish targets, and measure productivity gains, cost avoidance, and realized value
• Partner with Finance and Human Resources to validate assumptions, track benefits realization, and quantify business impact
• Drive development of dashboards and reporting tools providing visibility into initiative progress, key metrics, and outcomes
• Lead cross-functional execution by aligning stakeholders, removing barriers, accelerating implementation, and driving accountability
• Facilitate enterprise-wide communication and coordination for strategic transformation initiatives
• Collaborate with global teams across multiple time zones

Director, EPMO Resource Optimization

Manager

• Serve as the primary point of communication and accountability for study start-up and maintenance activities
• Oversee functional group activities involved in site activation to ensure critical-path activities are completed on time and within budget
• Compile, manage, track, and analyze site activation activities
• Support feasibility and site identification activities as needed
• Expedite Site Qualification and Selection processes
• Communicate Site Activation and Regulatory project status to sponsors and project teams
• Prepare risk assessments and mitigation plans
• Ensure study activities are included in work order budgets and track out-of-scope activities through change orders
• Develop and maintain site activation project plans
• Contribute to SOPs, best-practice guidelines, training, and coaching
• Provide input to departmental process improvement initiatives
• Establish and interpret site activation metrics to drive corrective action and achieve KPIs
• Support business development through proposals and bid defense meetings
• Report and escalate issues to leadership to resolve risks and protect deliverables
• Comply with SOPs, ICH GCP, and applicable regulations
• Liaise with functional contributors and vendors
• Perform other duties as assigned

Site Activation Manager

Project Manager

• Oversee and be accountable for the successful conduct of assigned projects
• Manage recruitment, training, development and performance reviews of personnel
• Develop business strategy and acquire new business in cooperation with business and senior management
• Develop and maintain effective client relationships
• Manage alliance partnerships
• Fulfill Sub-TA Head responsibilities
• Collaborate with scientific and therapeutic leaders across all clinical trial aspects
• Bridge project teams and provide innovative solutions within the Rheumatology therapeutic area

Senior Director, Project Management – Rheumatology

Paralegal

• Maintain employment litigation trackers
• Coordinate litigation holds and preservation activities
• Maintain custodian lists and legal hold documentation
• Support eDiscovery and information governance initiatives
• Manage matter files, deadlines, and litigation-related documentation
• Assist with document collection, organization, and production
• Coordinate communications and information requests with outside counsel
• Support mediation, arbitration, litigation, and settlement administration
• Coordinate review of global PSC and legal templates by local counsel
• Maintain severance and investigation trackers
• Organize and maintain employment law precedent materials and template libraries
• Assist with policy implementation and template review initiatives
• Assist with HR Compliance initiatives
• Support employment-related due diligence activities
• Support integration project plans, issue logs, and action trackers
• Coordinate document requests and information gathering
• Support employee transfer and harmonization projects related to acquisitions and corporate reorganizations
• Assist with employment integration efforts across multiple jurisdictions
• Maintain trackers, reporting dashboards, and project plans
• Monitor deadlines and follow-up items
• Coordinate meetings and action items across stakeholders
• Track outside counsel engagements and legal spend information
• Report directly to the Senior Employment Legal Counsel
• Support the Company's global employment law function and PSC organization

Litigation & Employment Paralegal, US

Clinical Research

• Perform feasibility studies for potential sites
• Conduct pre-study, study initiation and interim monitoring visits in adherence to protocol requirements
• Function as Lead CRA for global studies and coordinate CRAs
• Develop Clinical Monitoring Plans as requested
• Review site visit trip reports and provide feedback and edits
• Mentor and guide less experienced CRAs and site staff
• Design study-specific tools and templates
• Participate in study team, investigator and bid defense meetings
• Create and conduct training for study team members or colleagues
• Work with Project Management to evaluate deliverables and study milestones
• Compile regulatory and ethical submission documentation
• Coordinate study material shipment and receipt by sites
• Document site visit findings through written reports
• Provide input into protocols and CRFs
• Assess, monitor and train site staff on protocol adherence
• Review subject safety information and informed consent
• Conduct source document verification for compliance, patient safety and data veracity
• Review paper or electronic CRFs and assist with data query resolution
• Assist with Investigator Site File maintenance
• Maintain regular communication with sites
• Update site-related documentation for filing in the Trial Master File
• Ensure site compliance with investigational product receipt, accountability and return or destruction
• Conduct accompanied site visits for CRA assessment or training
• Complete final site close-out visit and report
• Perform other assigned duties

Senior Clinical Research Associate

• Manage research activities at sites participating in Worldwide’s clinical research projects
• Identify potential sites to participate in clinical research
• Perform study start-up activities, including collecting regulatory documents and supporting contract and budget negotiations
• Train sites to collect data properly and report potential safety-related events
• Manage site activities during study maintenance
• Close down research activities at sites once studies conclude
• Conduct study initiation visits (SIVs)
• Ensure compliance with informed-consent procedures, safety-event reporting, and applicable regulatory requirements
• Perform most site-management efforts remotely

Senior Clinical Research Associate – Oncology

• Manage research activities at sites participating in Worldwide’s clinical research projects
• Identify potential sites for clinical research participation
• Perform study start-up activities, including collecting regulatory documents and supporting contract and budget negotiations
• Train sites to collect data properly and report potential safety-related events
• Manage site activities during study maintenance
• Close down research activities at sites after study completion
• Conduct study initiation visits (SIVs)
• Ensure compliance with informed consent, safety-event reporting, and applicable regulatory requirements

• Perform feasibility studies for potential sites
• Conduct pre-study, study initiation, interim monitoring, site management, and study close-out visits
• Function as Lead CRA for global studies and coordinate CRAs
• Develop Clinical Monitoring Plans
• Review site visit trip reports and provide feedback
• Mentor and guide less experienced CRAs and site staff
• Design study-specific tools and templates
• Participate in study team, investigator, and bid defense meetings
• Create and conduct training for study team members or colleagues
• Work with Project Management to evaluate deliverables and study milestones
• Compile regulatory and ethical submission documentation
• Coordinate shipment and receipt of study materials
• Document site visit findings in written reports
• Provide input into protocols and CRFs
• Assess, monitor, and train site staff on protocol adherence
• Review subject safety information and informed consent
• Conduct source document verification
• Review CRFs in paper or electronic data capture systems and assist with data query resolution
• Assist sites with Investigator Site File maintenance
• Maintain regular communication with sites
• Update site-related documentation for Trial Master File filing
• Ensure site compliance with investigational product receipt, accountability, and return or destruction
• Conduct accompanied site visits for CRA assessment or training
• Complete final site close-out visits and reports
• Perform other duties as assigned

Senior Clinical Research Associate – CVM/IMID

• Provide leadership and direction to clinical site management team members from study start through closure
• Serve as Site Management’s primary point of contact and representative for clinical monitoring and site activities within the project
• Act as the primary sponsor contact
• Manage monitoring deliverables to achieve the study budget
• Identify out-of-scope activities

Senior Clinical Trial Manager – Oncology

• Assist in building and own a forecast model for needs outside of Medidata Payments
• Develop forecasting processes and link them with Medidata Payments forecasts
• Gather current site enrollment and patient enrollment data
• Collaborate with Revenue Recognition, Clinical Payments, Investigator Grants Payments, Project Analyst, Central Planning, and Clinical Operations teams
• Confirm adherence to financial audit requirements
• Create client-ready forecast deliverables
• Perform forecast analysis, including plan versus actuals and total budget needs
• Notify stakeholders of over-forecast or under-forecast variances
• Support year-end and interim audit processes
• Support the Clinical Operations process
• Stay current with local and global revenue regulations
• Ensure accurate and timely client reporting
• Perform final study closeout reconciliation and provide client-ready reports

General

• Support strategic feasibility assessments during proposal phases, including Study Burden Analysis and Patient and Site insights
• Develop bespoke Patient and Site support strategies and articulate their value propositions
• Present at bid defenses and client meetings as needed
• Develop and maintain collaborative relationships with internal stakeholders
• Capture, collate, and share patient experience data and insights to inform strategy and planning
• Evaluate Patient Pathway and trial burden for new study opportunities and communicate associated risks and support needs
• Maintain and develop strategic relationships with Patient Advocacy groups in assigned therapy areas
• Incorporate indication-specific representation and inclusion aspects into strategic customer recommendations
• Build FDA Diversity Action Plans, UK Patient and Public Involvement projects, and other patient engagement projects
• Maintain relationships with external vendors providing Patient and Site engagement, recruitment, and retention support services
• Translate patient engagement strategies into operational and tactical plans with project teams
• Establish metrics and measure the impact of patient and site support strategies on clinical trial delivery performance
• Maintain industry trend knowledge and communicate potential impacts to stakeholders
• Perform other duties as assigned

Director, EPMO Resource Optimization – North America, Europe

Clinical Trials Associate

Grants Payments Data Analyst

Manager, Talent Acquisition – Contract

Director, EPMO Resource Optimization

Site Activation Manager

Senior Director, Project Management – Rheumatology

Litigation & Employment Paralegal, US

Senior Clinical Research Associate

Senior Clinical Research Associate – Oncology

Senior Clinical Research Associate – Oncology

Senior Clinical Research Associate – CVM/IMID

Senior Clinical Trial Manager – Oncology

Grants Payments Data Analyst

Patient Engagement Lead