Parexel

Compliance

• Provide quality leadership and guidance to R&D stakeholders on GCP-related activities
• Serve as a subject matter expert for clinical compliance matters
• Act as a Clinical Compliance representative on clinical study teams across assigned therapeutic areas
• Build collaborative partnerships with cross-functional stakeholders and provide ongoing coaching and compliance guidance
• Conduct risk assessments of clinical trial activities and identify priority studies, key compliance activities, compliance metrics, and high-risk vendors
• Identify, assess, and escalate significant quality and compliance issues, including support for serious breach evaluations
• Participate in CRO and vendor governance activities for assigned studies and therapeutic areas
• Maintain working relationships with CRO quality teams to review and address quality and compliance matters
• Support vendor evaluations as a subject matter expert
• Develop responses and CAPAs associated with internal and external audit findings
• Provide guidance on deviation reporting, root cause analysis, and CAPA development and evaluation
• Identify trends in quality and compliance risks and implement effective, risk-based solutions
• Support internal audits, regulatory inspections, inspection readiness activities, and project team training

Clinical Compliance Manager – FSP

Clinical Research

• Manage clinical sites from identification through closeout
• Serve as the primary point of contact for assigned clinical sites
• Conduct qualification, site initiation, monitoring, and termination visits at assigned clinical sites
• Prepare timely visit and contact reports
• Manage site quality and delivery
• Address site questions and resolve issues
• Oversee study integrity and build relationships with investigators and site staff
• Review trial performance and safeguard study participants' rights, safety, and well-being
• Develop patient recruitment strategies to support enrollment timelines
• Ensure compliance with SOPs, study protocols and amendments, Good Clinical Practice, and regulatory requirements
• Evaluate reported data quality and integrity, site performance, and investigational product accountability
• Monitor regulatory documentation completeness and quality
• Perform site document verification

Clinical Research Associate – CRA II/Senior, Metabolic

• Manage Quality Events, Quality Issues, deviations, and related investigations with relevant stakeholders
• Act as Deviation Owner and support CAPA definition, implementation, tracking, effectiveness assessment, and closure
• Support internal and external audits, audit readiness activities, and remediation of audit findings
• Ensure quality records, supporting documentation, and evidence are complete, accurate, traceable, and inspection ready
• Support third-party governance and oversight from a quality and compliance perspective
• Contribute to third-party Quality Risk Assessments for GMA activities, including non-interventional studies, real-world evidence/data activities, Research Collaborations, and partnerships
• Follow up on identified risks and mitigation actions
• Identify, assess, and escalate risks from third-party due diligence, qualification, and oversight
• Ensure compliance with SOPs, business guidance documents, quality standards, and regulatory requirements
• Support Research Collaboration and selected non-vendor third-party due diligence and assessment activities
• Coordinate with internal stakeholders and third parties to obtain due diligence information and documentation
• Maintain and continuously improve TPM due diligence tools, including TPIAT
• Lead or contribute as a subject matter expert to the design, revision, implementation, and improvement of GMA V&TPM quality, compliance, governance processes, standards, procedures, and guidance
• Provide V&TPM quality and compliance expertise, guidance, and training
• Collaborate with ESP Quality Assurance, Medical QA, GMA Medical Governance & Risk Management, Procurement, Vendor & Partner Governance, and other stakeholders

Vendor & Third-Party Management Quality and Compliance Manager

Procurement

• Manage Quality Events (QEs), Quality Issues (QIs), deviations, and related investigations with relevant stakeholders
• Act as Deviation Owner, as appropriate, and support CAPA definition, implementation, tracking, effectiveness assessment, and closure
• Support internal and external audits, audit readiness activities, and remediation of audit findings
• Ensure quality records, supporting documentation, and evidence are complete, accurate, traceable, and inspection ready
• Support third-party governance and oversight activities from a quality and compliance perspective
• Support and contribute to third-party Quality Risk Assessments (QRAs) for GMA activities, including non-interventional studies, real-world evidence/data activities, Research Collaborations, and partnerships
• Follow up on identified risks and mitigation actions
• Identify, assess, and escalate risks arising from third-party due diligence, qualification, and oversight activities
• Ensure compliance with applicable SOPs, business guidance documents, quality standards, and regulatory requirements
• Support Research Collaboration and selected third-party non-vendor due diligence and assessment activities
• Ensure due diligence and assessment documentation is accurate and complete in TPM systems and tools
• Coordinate with internal stakeholders and third parties to obtain required due diligence information and documentation
• Support maintenance and continuous improvement of TPM due diligence tools, including TPIAT
• Lead or contribute as a subject matter expert to the design, revision, implementation, and improvement of V&TPM quality, compliance, governance processes, standards, procedures, and guidance
• Provide quality and compliance expertise, guidance, and training to operational teams and stakeholders
• Collaborate with Quality Assurance, Medical QA, Medical Governance & Risk Management, Procurement, Vendor & Partner Governance, and other stakeholders

Vendor Management Quality and Compliance Manager - FSP

• Manage clinical sites from identification through closeout
• Conduct qualification visits, site initiation visits, monitoring visits, and termination visits at assigned clinical sites
• Prepare timely visit and contact reports
• Serve as the primary point of contact for assigned clinical sites
• Address site questions and resolve issues to support successful study execution
• Oversee study integrity and build relationships with investigators and site staff
• Review trial performance and safeguard study participants’ rights, safety, and well-being
• Develop patient recruitment strategies with clinical sites to support enrollment timelines
• Ensure compliance with standard operating procedures, study protocols and amendments, Good Clinical Practice, and applicable regulatory requirements
• Evaluate reported data quality and integrity, site performance, and investigational product accountability
• Monitor regulatory documentation completeness and quality
• Perform site document verification

Clinical Research Associate, CRA II/Senior – Ophthalmology

• Manage clinical sites from identification through closeout
• Serve as the primary point of contact for site teams
• Conduct qualification, site initiation, monitoring, and termination visits at assigned clinical sites
• Prepare timely visit and contact reports
• Manage site quality and delivery throughout the study lifecycle
• Address site questions and resolve issues supporting study execution
• Oversee study integrity and maintain relationships with investigators and site staff
• Review trial performance and safeguard participant rights, safety, and well-being according to protocol
• Develop patient recruitment strategies with clinical sites
• Ensure compliance with standard operating procedures, study protocols and amendments, Good Clinical Practice, and regulatory requirements
• Evaluate reported data quality and integrity, site performance, and investigational product accountability
• Monitor regulatory documentation completeness and perform site document verification

Clinical Research Associate – Senior, Oncology

General

• Lead site activation planning and strategy development for assigned clinical studies, overseeing milestones and deliverables from site feasibility through last site activation
• Develop, coordinate, and execute study critical path plans, including site feasibility, site selection, Regulatory Green Light, site initiation, site activation, system setup, Trial Master File and Expected Document List management, ethics committee and regulatory authority or Ministry of Health strategy, informed consent form customization, risk mitigation, activation requirements, tools, documents, and reporting
• Monitor and report site activation progress across multiple studies, identify potential delays and risks, and lead cross-functional teams in resolving complex activation challenges
• Provide guidance to site activation team members and serve as a liaison among project management, site start-up teams, site activation functions, and clinical operations leadership
• Manage client relationships and communications regarding site activation timelines and deliverables, and serve as the Study Start-Up Subject Matter Expert for designated client accounts
• Provide strategic guidance, best practice recommendations, and technical expertise to support study initiation and site activation outcomes
• Support business development activities by contributing site activation expertise to proposals and bid pursuit meetings
• Implement standardized site activation processes and best practices, analyze activation metrics, and drive process optimization and quality initiatives
• Ensure compliance with regulatory requirements and company Standard Operating Procedures, and contribute to site activation procedures and templates
• Lead use of Clinical Trial Management System, Electronic Data Capture, Interactive Response Technology, and Trial Master File systems to optimize site activation workflows
• Oversee documentation, data integrity, system maintenance, timeline planning, and resource allocation across the assigned portfolio

Site Activation Leader

• Conduct source data verification and ensure clinical trial data is submitted to data management promptly
• Identify study conduct issues and ensure appropriate closure
• Manage investigator site workload to run studies efficiently and meet objectives
• Ensure studies comply with ICH/GCP, local laws, and client SOPs
• Maintain patient safety and report safety issues according to regulatory requirements
• Inform principal investigators and site staff of issues
• Develop corrective and preventive actions with investigators and site personnel
• Manage sites from selection through study closeout
• Train site staff on protocols, amendments, and client processes
• Maintain sufficient knowledge of the product, protocol, and therapy area
• Interact with healthcare professionals and support client credibility
• Ensure monitored data meets quality standards and is entered into client systems promptly
• Report study progress after site visits and catalog and close issues
• Maintain accurate site-level clinical trial registry information
• Obtain and maintain Investigator Initiation Package, Site Master File, ELARA, and/or Trial Master File documentation
• Quality-control relevant documents and maintain monitoring logs
• Generate site monitoring reports
• Complete required training, timesheets, expense reports, and CV updates
• Comply with Parexel processes, ICH-GCP, and applicable requirements

Clinical Research Associate II

Affiliate Manager

• Lead or support operational activities from study start-up through close-out for assigned studies and investigator sites
• Ensure compliance with study timelines, prevailing laws, Good Clinical Practices, and client standards
• Initiate and coordinate start-up activities and essential document management toward high-quality Investigator Initiation Packages and site initiation approval
• Resolve or escalate site issues and coordinate supporting roles for timely site activation
• Prepare, validate, and submit regulatory documents, including IIP, IRB approval forms, and FDA 1572/Attestation Forms
• Support Central Investigator Review Board packages and country-required committee submissions
• Coordinate communications and responses between clients and central ethics committees
• Support investigator sites through local IRB preparation, submission, and approval workflows
• Prepare, handle, and distribute clinical documentation and reports
• Support and implement Shared Investigator Platform activities aligned with client strategy
• Manage essential documents and updates throughout study conduct, including protocol amendments, FDA 1572/Attestation revisions, and ethics committee annual approvals
• Maintain IRB/Ethics Committee activities
• File documents to the Trial Master File and assist with periodic quality reviews
• Update and maintain clinical trial systems tracking site compliance and performance
• Support investigator sites and study teams with audit and inspection responses
• Maintain ongoing communication with study teams and investigator sites
• Provide country- and site-level functional updates and establish tools for efficient status reporting
• Disseminate ethics approvals and communicate local site approvals to stakeholders
• Conduct site personnel awareness sessions as needed
• Identify and resolve site issues and coordinate corrective and preventive actions
• Serve as a Site Activation Partner point of contact or subject matter expert as assigned
• Represent the SAP function on systems, processes, and global initiatives
• Mentor new hires on processes and systems
• Complete required training, timesheets, expense reports, and CV updates
• Maintain knowledge of and comply with Parexel processes, ICH-GCP, and applicable requirements

Site Activation Partner I – FSP, Fixed-Term 7 months

• Lead or support operational activities from study start-up through close-out for assigned studies and investigator sites
• Initiate and coordinate activities and essential document management for Investigator Initiation Packages and site activation
• Register and maintain investigator sites and client stakeholders in client registries and systems
• Interact with investigator sites to confirm start-up readiness and review site profiles, essential documents, contracts, supplies, payments, and IRB information
• Resolve and escalate site issues within required timelines
• Prepare, validate, and submit regulatory documents for internal approval
• Coordinate supporting roles and activities to ensure timely site activation
• Support Central and local IRB/Ethics Committee packages, submissions, communications, and approvals
• Assist with non-clinical trial supplies, tracking, clinical documentation, filing, and archiving
• Support electronic Investigator Site File readiness and manage access before Site Initiation Visits
• Coordinate in-scope document translations
• Manage study documents and updates throughout study conduct, including protocol amendments, FDA 1572/Attestation revisions, and annual Ethics Committee approvals
• File documents to the Trial Master File and support quality reviews and audits/inspections
• Maintain clinical trial systems tracking site compliance and performance
• Communicate study, country, and site updates, approvals, issues, delays, and escalations to stakeholders
• Provide site personnel awareness sessions on client requirements and compliance
• Complete assigned training and adhere to EP and client SOPs and processes
• Learn and potentially implement site activation processes across more than one country
• Potentially serve as study Point of Contact, Subject Matter Expert, global initiative representative, or mentor

• Initiate and coordinate clinical trial site activation activities and essential document management
• Compile high-quality Investigator Initiation Packages leading to site initiation approval
• Prepare, validate, and submit regulatory documents including IIP, IRB approval forms, and FDA 1572/Attestation Forms
• Coordinate supporting roles and activities to ensure timely site activation
• Support central and local ethics committee packages, submissions, approvals, and communications
• Support investigators with local IRB workflows from preparation through approval
• Prepare, handle, and distribute clinical documentation and reports
• Support and implement activities in the Shared Investigator Platform
• Coordinate essential documents and updates throughout study conduct, including protocol amendments, FDA 1572/Attestation revisions, and annual ethics approvals
• Maintain IRB/Ethics and other committee activities
• File documents to the Trial Master File and assist with periodic quality reviews
• Update and maintain clinical trial systems tracking site compliance and performance
• Support investigator sites and study teams with audit and inspection responses
• Maintain communication with study teams and investigator sites; provide country/site updates
• Disseminate ethics approvals and communicate site approvals to stakeholders
• Conduct site personnel awareness sessions as needed
• Identify and resolve investigator site issues and support corrective and preventive actions
• Act as a subject matter expert or point of contact for site activation, systems, processes, and global initiatives
• Support mentoring of new hires
• Complete required training, timesheets, expense reports, and CV updates
• Maintain compliance with Parexel processes, ICH-GCP, and applicable requirements

Site Activation Partner I – Temporary Contract

• Prepare, submit and maintain Clinical Trial Applications (CTAs) acting as Local Regulatory Contact (LRC) and/or Regulatory Lead (RL)
• Support CTIS submissions, amendments, notifications and regulatory interactions with regulatory authorities
• Manage post-authorisation activities, including variations, renewals, transfers and other lifecycle maintenance procedures
• Review and update product information documents (SmPC, PIL, labelling texts) and artwork materials in compliance with local and EU requirements
• Coordinate with internal project teams, clients and regulatory authorities to ensure timely and compliant submissions
• Track regulatory commitments, maintain documentation and support regulatory strategy implementation
• Work under the general direction of a Project Lead and/or Technical SME, ensuring client work is delivered on time and meets quality expectations
• Potentially act in a client-facing role with guidance and support from line management

Senior Regulatory Affairs Associate – CTA, MAA

• Lead or support operational activities from study start-up through close-out for assigned studies and investigator sites
• Initiate and coordinate activities and essential document management for Investigator Initiation Packages and site initiation approval
• Register and maintain investigator sites and client stakeholders in required registries and systems
• Interact with investigator sites to confirm readiness for start-up and review site profiles, essential documents, contracts, clinical supplies, payments, and IRB status
• Resolve and escalate site issues and concerns
• Prepare, validate, and submit regulatory documents, including IIP, IRB approval forms, and FDA 1572/Attestation Forms
• Coordinate supporting roles and activities for timely site activation
• Support central and local IRB submissions, ethics committee communications, approvals, and workflows
• Assist with non-clinical trial supplies, tracking, clinical documentation, filing, and archiving
• Support eISF readiness and manage site and monitor access before Site Initiation Visits
• Coordinate document translation with preferred vendors
• Manage post-activation documents and updates throughout the study lifecycle, including protocol amendments and ethics approvals
• Maintain IRB/Ethics Committee activities and file documents to the Trial Master File
• Update clinical trial systems tracking site compliance and performance
• Support site audits and inspections
• Maintain communication with study teams and investigator sites and provide country/site updates
• Disseminate ethics and local site approvals to study teams and stakeholders
• Conduct awareness sessions on client requirements and documentation compliance as needed
• Identify and resolve investigator site issues and coordinate corrective and preventative actions
• Complete assigned training and adhere to Parexel and client SOPs and processes
• Potentially serve as study point of contact, subject matter expert, global initiative representative, or mentor

Site Activation Partner I

Clinical Operations

• Lead local Ethics Committee and Regulatory Authority submissions, including initial submissions and protocol amendment submissions
• Independently prepare and manage submissions to Ethics Committees and Regulatory Authorities
• Complete and maintain XML documentation as required for submissions
• Prepare informed consent forms using approved templates
• Ensure compliance with ICH/GCP, country regulations, sponsor policies and procedures, quality standards, and adverse event reporting requirements
• Apply in-depth knowledge of the local regulatory environment, submission processes, and approval pathways to support study startup activities
• Manage investigational medicinal product-related local supply activities, including coordination with vendors providing background medications and standard of care supplies
• Review and validate translated study documents
• Support protocol performance and compliance activities across assigned studies within France
• Collaborate with study teams and stakeholders to facilitate timely regulatory approvals and study progress

Regulatory & Submissions Lead – Clinical Operations Manager

• Act as the primary site contact and site manager throughout all phases of a clinical research study
• Take overall responsibility for allocated sites
• Develop strong site relationships and ensure continuity throughout all trial phases
• Perform clinical study site management and monitoring activities in compliance with ICH-GCP, sponsor SOPs, local laws and regulations, protocol, site monitoring plan, and associated documents
• Gain in-depth understanding of the study protocol and related procedures
• Coordinate and manage tasks with sponsor roles to achieve Site Ready
• Participate in site selection and validation activities
• Perform remote and on-site monitoring and oversight activities
• Conduct validation, initiation, monitoring, and close-out visits
• Prepare timely, clear, comprehensive, and accurate visit and non-visit contact reports
• Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out
• Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, deviations, regulatory documentation, audits/inspections, and site performance
• Identify, assess, resolve, and escalate site performance, quality, or compliance problems
• Collaborate with internal functional teams, vendors, IRBs/IECs, and regulatory authorities
• Maintain information and documentation in CTMS, eTMF, and other systems
• Act as a process subject matter expert, share best practices, and provide training
• Support or lead audit/inspection activities
• Mentor or buddy junior CRAs and perform co-monitoring visits
• Contribute to business initiatives and projects
• Complete required training, timesheets, expense reports, and CV updates

Clinical Compliance Manager – FSP

Clinical Research Associate – CRA II/Senior, Metabolic

Vendor & Third-Party Management Quality and Compliance Manager

Vendor Management Quality and Compliance Manager - FSP

Clinical Research Associate, CRA II/Senior – Ophthalmology

Clinical Research Associate – Senior, Oncology

Site Activation Leader

Clinical Research Associate II

Site Activation Partner I – FSP, Fixed-Term 7 months

Site Activation Partner I – FSP, Fixed-Term 7 months

Site Activation Partner I – Temporary Contract

Senior Regulatory Affairs Associate – CTA, MAA

Site Activation Partner I

Regulatory & Submissions Lead – Clinical Operations Manager

Senior Clinical Research Associate