Parexel

Project Manager

• Develop and execute supply strategies for IMP/NIMP, ANS, and laboratory samples
• Ensure GLP, GDP, GMP compliance across all participating countries
• Manage project timelines, budgets, and operational resources
• Oversee third-party providers and negotiate contracts
• Conduct risk assessments and develop mitigation plans
• Serve as regulatory point of contact and resolve client issues
• Lead process improvements and system optimization

Supply & Logistics Project Manager – Clinical Trials

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
• Provide study teams with high-impact graphical tools to support early development decision-making
• Serve as a partner and point of support for clinical scientists, offering training and ongoing consultation
• Create and maintain standardized data visualizations to support Medical Data Review and safety signal detection
• Apply defined visualization standards to generate outputs aligned with Risk-Based Quality Management (RBQM) principles and Critical to Quality (CtQ) endpoints
• Work under guidance to implement visual analytics within timelines tied to First Patient In (FPI) or predefined safety milestones
• Support documentation and quality control of visualization deliverables to ensure traceability and compliance
• Participate in training sessions and incorporate feedback from experienced Real-time Visual Analytics Specialists
• Address moderately complex statistical or data issues, balancing scientific rigor with appropriate flexibility.

Real-time Visual Analytics Specialist

Manager

• Responsible for performing important project planning activities in support of team deliverables and the PRD portfolio.
• Coordinate, monitor and report project schedule and resource management information.
• Partner with key team members to manage the project and achieve milestones.

Manager, Project Planner – FSP

• Oversee the planning, execution, and support of clinical site management contracting activities performed by SCBAs
• Recruit, manage and lead SCAs across their respective region
• Ensure SCAs are adequately trained and support training needs
• Ensure SCAs achieve expected quality compliance standards
• Allocate study assignments and coordinate the activities of SCBAs
• Ensure SCBAs meet expected study timelines and study objectives
• Support SCBAs with resolution of significant legal, budget, or payment related issues
• Perform periodic review of SCBA processes to ensure maximum efficiency without adversely affecting customer service
• Identify opportunities to improve processes, efficiency, and team effectiveness
• Encourage innovation and continuous learning within the team

Site Contracts and Budgets, Line 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

Director

• Responsible for hands-on development of high-quality, client-ready RWD Strategy-related materials
• Attend and represent RWD Strategy for Europe opportunities with clients
• Identify opportunities where RWD will be a value-add
• Responsible for the execution of a global RWD acquisition strategy
• Perform return-on-investment assessments that inform decision-making
• Operate governance frameworks for regional RWD partners and suppliers
• Ensure that data access and use is fully operational
• Monitor KPIs used to ensure impactful use of data
• Monitor partner capabilities and services
• Provide input for system architecture and contribute to capability presentations

Director RWD Strategy

Compliance

• Support the coordination, preparation, and delivery of regulatory submissions and lifecycle management (LCM) activities in accordance with submission strategies defined by the RRL and coordinated by the Regional Submission Coordinator (Lead).
• Assist in organizing submission team meetings (e.g., Kick-off Meetings) and follow up on agreed actions.
• Coordinate, request, and track documentation from Subject Matter Experts (SMEs) to support submission readiness and timelines.
• Support the preparation and maintenance of the Submission Content Plan (SCP) under the guidance of the RSC Lead.
• Ensure timely dispatch of non-eCTD submission packages to LRRs and RPRs and track dispatched documentation per country.
• Provide hands-on operational support for labeling activities, performing assigned tasks under the guidance of the RSC Lead.
• Prepare annotated labeling documents for regulatory review in collaboration with RRLs, LRRs, and RPRs.
• Initiate and coordinate mock-up requests in the Artwork Management System.
• Track print releases as required.
• Support change control activities related to local labeling updates.
• Ensure appropriate archiving of labeling documentation and that approved labeling is accurately and timely stored in DocNet.
• Support the creation, maintenance, and accuracy of submission and regulatory records in regulatory systems (e.g., Veeva RIMS, Apollo).
• Upload Module 1 and non-eCTD submission documents to DocNet and ensure completeness and traceability.
• Update regulatory systems with Health Authority interactions, including uploading questions received from Health Authorities in the appropriate records.
• Support data quality and consistency across systems and documentation repositories.
• Provide regular status updates to the Regional Submission Coordinator (Lead) on assigned activities, timelines, and potential issues.
• Support tracking of submission milestones, deliverables, and dependencies.
• Escalate operational issues or delays to the RSC Lead with appropriate context and proposed mitigation actions.
• Collaborate effectively with cross-functional teams including CMC, labeling, quality, and regulatory stakeholders.
• Perform assigned activities in compliance with applicable SOPs, work instructions, and regional regulatory requirements.
• Support inspection readiness by ensuring accurate, complete, and well-organized submission and labeling documentation.
• Maintain awareness of regional regulatory processes relevant to assigned activities and follow guidance provided by the Lead and RRLs.

Regulatory Submission Coordinator

• Provides operational leadership throughout the study lifecycle
• Leads and coordinates the execution of a clinical trial globally
• Provides quality oversight and coordination of regional and country operations
• Drives decision making and works closely with the Clinical Study Team Lead
• Ensures development of study level plans
• Approves and oversees drug supply management
• Monitors vendor contracts for out of scope activities and budget spend
• Provides ongoing assessment of subject enrollment
• Serves as technical expert for study management systems and processes

Global Study Manager II

Clinical Research

• Manages all operational aspects for implementation of one or more clinical trials and all activities from study start-up through database lock, ensuring Good Clinical Practices (GCP) and relevant SOPs are met
• Manages study-related service providers and serves as the primary point of contact for contracted CROs, study staff, and contract labs as appropriate
• Identifying potential risks and resolving issues with CROs; and ensuring study feasibility is performed as appropriate
• Participates in CRO selection process, validates clinical scope of work, supports auxiliary service outsourcing, provides input into vendor management plan, reviews quality metrics, and shares lessons learned as required
• Manages and executes vendor kick off meetings, face-to-face meetings, team training, and trial WebEx as required for trial execution
• Reviews and oversees the development, review, and operational aspects of site investigator grants and grant payment in accordance with sponsor process requirements
• Coordinates and manages investigator meetings including development of the agenda, management of slide development and review, coordination of meeting planner activities, and presenting at investigator meeting
• Leads and/or supports clinical operational team meetings in support of the respective clinical trial including drafting agenda, collecting minutes, filing minutes in the TMF, tracking action items, providing ongoing status of trial enrollment and timelines, outlining vendor related deliverables, communicating risk/issues, and managing input from other internal and external partners

Senior Clinical Trial Manager

• Coordinate the preparation, compilation, and submission of new drug applications and lifecycle management (LCM) activities in alignment with submission strategy
• Coordinate closely with Global Submission Coordinators to ensure completeness of core documentation
• Organize submission team meetings and facilitate effective communication among all stakeholders
• Open required records in submission planning tools and Regulatory Information Management Systems
• Prepare Submission Content Plans (SCP) based on country-specific regulatory requirements
• Coordinate, request, and track documentation from relevant SMEs to ensure timely and complete submission readiness
• Provide regular updates to the submission team on status and timelines
• Draft M1 documents as required and coordinate their review with LRR or RPR
• Support labeling preparation
• Upload M1 documents in archiving system

Senior Regulatory Affairs Associate – Regional Submission Coordinator

Research Analyst

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices
• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through database lock, ensuring relevant timelines and quality deliverables are met
• Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
• Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
• Serve as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks, when applicable

Senior Clinical Research Associate – Sponsor Dedicated

• Accountable for centralized monitoring activities for global and/or complex trials
• Analytical data review of key risk and/or operational performance data
• Present findings as an integral member of the Clinical Study team
• Collaborate on Study Quality Risk Assessment
• Lead the creation of the Central Monitoring Plan
• Work with data analysts to configure, implement, and execute the Central Monitoring RBQM system
• Conduct study-level Central Monitoring Reviews

Manager, Central Monitoring – Senior Central Monitoring Associate

• Responsible for hands-on development of high-quality client-ready RWD Strategy-related materials
• Identify opportunities where RWD will be a value-add
• Responsible for the execution of a global RWD acquisition strategy within the region
• Monitor partner capabilities and services
• Develop and maintain working relationships with relevant stakeholders

• 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 – FSP

• Contributes to the selection of potential investigators
• Responsible for study start-up and regulatory maintenance
• Ensures the sites are always inspection ready
• Manages study supplies and drug accountability at study site
• Performs monitoring visits and Source Data Review