Parexel

Analyst

• Analyze scientific and operational data to support the Data Surveillance process
• Review project-specific Quality Tolerance Limits
• Assist in developing Data Surveillance Plans (DSPs) and conduct defined project reviews
• Attend internal and external Data Surveillance meetings, presenting relevant findings to the project team
• Document findings from Data Surveillance activities in the DS Findings Form
• Provide feedback and work with Technology teams to identify potential solutions
• Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines
• Collaborate with DS Team Members to correlate findings from various sources
• Support documentation of actions in Clue Points Issue Management system
• Complete, share, and file Central Monitoring Report

Data Surveillance Analyst

Compliance

• Develop, publish, and support the publishing of regulatory submissions to global health authorities in alignment with established standards, requirements, and organizational commitments.
• Ensure all submissions are prepared in high-quality, compliant formats.
• Perform related activities as needed and provide support to both internal and external stakeholders.

Regulatory Affairs Associate

Operations

• Responsible for study and country level activities from start up through conduct and study close.
• Responsible for study management aspects of assigned studies, including vendor and budget management.
• Regional/Country/Study level implementation of Start-up and Site Activation Plans.
• Responsible for country/study level Recruitment Strategy.
• Communication with the local team and internal stakeholders and CRO partner to ensure efficient and timely study delivery of the agreed plans.
• Responsible for study and/or country vendor management and oversight including follow up and coordination of vendor deliverables.

Country Study Operations Manager – France

Medical Billing and Coding

• Responsible for coding assigned clinical trials
• Coding medical review - Responsible for review of coded data for coding consistency, accuracy, and compliance with coding guidelines
• Prepares and forwards coding reports for medical review
• Collaborates effectively with cross-functional teams to ensure accurate, consistent, and timely medical coding that aligns with project goals and regulatory requirements

Clinical Coder – FSP

Research Analyst

• Responsible for site management and monitoring of clinical trials
• Ensure patient safety and quality study execution
• Manage operational aspects from site activation to database lock
• Serve as the primary contact for investigator sites
• Monitor site level adverse events and resolve protocol-related issues

Clinical Research Associate – FSP

Director

• Works within a matrix environment, accountable for all operational aspects of 1 or more ERMTs
• May oversee a team of Vendor Startup Managers (VSM) or Imaging Operation Managers (IOM)
• Functions as a point of escalation for supplier issues
• Leverages knowledge and understanding of service category(s) and suppliers
• Leads business review meetings with vendors based on Key Performance Indicators (KPI)
• Manages escalated global vendor issues
• Ensures compliance with all required SOPs and business guidance documents

Vendor Alliance Lead Associate Director

• Responsible for site management, monitoring, and close-out of assigned clinical trials investigator sites
• Ensure patient safety and quality study execution in accordance with applicable laws, GCP, and client standards
• Manage investigator site relationships to ensure effective delivery of clinical trials
• Resolution of all protocol-related issues for assigned investigator sites
• Conduct onsite, remote/electronic monitoring as needed and ensure compliance with protocol

Senior Clinical Research Associate – FSP

Clinical Operations

• Manage clinical projects and ensure timely execution
• Collaborate with cross-functional teams to deliver successful project outcomes
• Oversee project timelines, budgets, and resources

Clinical Project Manager – FSP

• Responsible for site management, site monitoring and close-out of assigned clinical trials investigator sites
• Ensure patient safety and quality study execution in accordance with applicable prevailing laws, GCP, and client standards
• Manage investigator site relationships to ensure effective delivery of clinical trials
• Monitor site level adverse events and collaborate with the Drug Safety Unit
• Identify and resolve investigator site issues within required timeframes

• Ensure compliance with ICH GCP and local regulations
• Act as PAREXEL’s direct contact with assigned sites
• Evaluate site recruitment plans and implement corrective actions
• Conduct remote visits and on-site training as required
• Maintain positive, collaborative work environment

• Responsible for site management, monitoring, and close-out of assigned clinical trials
• Ensure patient safety and quality study execution
• Manage investigator site relationships and enhance company’s image

Senior Clinical Research Associate, Clinical Research Associate II

• Managing labeling ensuring compliance with regulatory requirements
• Support marketing authorization submissions and lifecycle management
• Coordinate artwork development and version control
• Collaborate with cross-functional teams for labeling accuracy

Regulatory Affairs Associate – Labeling, Marketing Application

• Act as a labeling strategist within Global Regulatory Affairs (GRA)
• Drive the maintenance of the Company Core Data Sheet (CCDS), the US Prescribing Information (USPI) and the EU Summary of Product Characteristics (SmPC) for product portfolio
• Ensure optimal alignment of the company position, labeling requirements, and commercial opportunities for a therapeutic area
• Manage the exception process between the CCDS and the USPI and EU SmPC
• Collaborate with relevant Subject Matter Experts and stakeholders
• Ensure consistent communication to the Global Labeling Associates, regions and countries regarding updated CCDSs for assigned portfolio of products
• Maintain compliance by leading the assessment and Global Labeling Committee review of proposed exceptions
• Represent Global Labeling on respective product Global Regulatory Affairs Strategy Teams

Regulatory Affairs Consultant – Labelling Strategy

Affiliate Manager

• Responsible for managing labeling ensuring compliance with regulatory requirements
• Support marketing authorization submissions, lifecycle management, and post-approval variations requiring labeling updates
• Prepare, review, and update product labeling according to requirements from Health authorities
• Ensure localized labeling content complies with each country’s standards
• Coordinate artwork development and version control with internal teams and external vendors
• Support Marketing Authorization Applications (MAAs), renewals, and variations that involve labeling changes
• Prepare labeling sections of the dossier per local format
• Work closely with RA, QA, supply chain, artwork teams, and local affiliates to ensure labeling accuracy and timely updates
• Act as liaison between global teams and local representatives
• Build networking within the industry and maintain client relationships

Regulatory Affairs Associate – Labeling VAR Coordination

• Act as the principal labeling strategist within Global Regulatory Affairs (GRA)
• Drive the development of Labeling strategies
• Ensure optimal alignment of the company position and labeling requirements
• Provide strategic input into the GRA Therapeutic Area Team from a labeling perspective
• Collaborate with various stakeholders and SMEs
• Lead the assessment and review of proposed exceptions
• Represent Global Labeling on product Global Regulatory Affairs Strategy Teams

Data Surveillance Analyst

Regulatory Affairs Associate

Country Study Operations Manager – France

Clinical Coder – FSP

Clinical Research Associate – FSP

Vendor Alliance Lead Associate Director

Senior Clinical Research Associate – FSP

Clinical Project Manager – FSP

Senior Clinical Research Associate – FSP

Clinical Research Associate – FSP

Senior Clinical Research Associate, Clinical Research Associate II

Regulatory Affairs Associate – Labeling, Marketing Application

Regulatory Affairs Consultant – Labelling Strategy

Regulatory Affairs Associate – Labeling VAR Coordination

Senior Regulatory Affairs Consultant – Labelling Strategy