Parexel

Administration

• Lead and manage ongoing regulatory submissions and maintenance activities
• Prepare, review, and track regulatory documents for submission to Ethics Committees, IRBs, and Regulatory Authorities
• Ensure timely and compliant submission of all required documentation
• Oversee the setup, population, and maintenance of the ISF with meticulous attention to detail
• Manage oversight and follow-up of budget and contract amendments
• Demonstrate solid understanding of local regulatory and Ministry of Health procedures, including ethics and regulatory processes
• Work closely with CRAs, study teams, and regulatory specialists to ensure seamless coordination between clinical operations and regulatory functions
• Contribute to the production and maintenance of study documents, ensuring template and version compliance

Senior Clinical Study Administrator

Manager

• Manage and conduct study start-up activities in compliance with client procedures, ICH-GCP guidelines, and local regulations
• Prepare, review, track, and manage site regulatory documentation at country and site levels
• Ensure timely collection and uploading of essential documents into the eTMF (electronic Trial Master File) in accordance with ICH-GCP standards
• Coordinate with regulatory authorities and IEC/IRB for submission of applications and required documentation during the start-up period
• Maintain, review, and report on site performance metrics and study progress
• Update CTMS (Clinical Trial Management System) and other systems with data from study sites according to required timelines
• Follow up on outstanding actions with study sites to ensure timely resolution
• Collaborate closely with CRAs and Local Study Teams to ensure regulatory and documentation compliance
• Support quality control checks to verify that all essential documents are collected and verified prior to site activation
• Contribute to clinical and operational feasibility assessments of potential studies
• Participate actively in Local Study Team meetings and provide regular updates to line management
• Support study selection processes by identifying and assessing potential sites and investigators (as needed)
• Take ownership of country-level start-up activities after feasibility completion through site activation
• Lead and manage initial clinical trial submissions, ensuring timely preparation, coordination, and follow-up with regulatory authorities and ethics committees
• Oversee start-up related budgets and support budget tracking during the start-up phase
• Manage and track Import License submissions and ensure timely approvals where applicable
• Monitor and coordinate Investigational Product (IMP) and study equipment delivery to ensure site readiness
• Drive site activation readiness by ensuring all regulatory, contractual, and logistical requirements are completed
• Proactively identify and mitigate risks or delays impacting study start-up timelines.

Study Start-Up Manager

Research Analyst

• Monitor clinical trial sites through on‑site and remote visits
• Build and maintain strong relationships with investigators and site staff
• Collaborate with cross‑functional teams to meet project timelines
• Manage site‑level study documentation, systems updates, and visit reports
• Implement corrective actions when needed to maintain study integrity
• Ensure sites are always audit- and inspection-ready

Clinical Research Associate II

Content Writer

• Lead end-to-end signal management activities
• Perform and oversee qualitative and quantitative signal analysis
• Ensure compliance with global pharmacovigilance regulations
• Provide oversight and author aggregate safety reports
• Manage timelines, resources, budgets, and risks
• Supervise and mentor line reports

Senior Manager, Medical Writing Services

Systems Engineer

• Own and optimize Microsoft 365 services (Teams, SharePoint, Exchange, OneDrive, Copilot)
• Drive adoption of M365 Copilot and modern collaboration tools
• Lead clear, end-user focused communication for M365 changes and updates
• Ensure platform performance, security, and compliance
• Partner with business and IT to deliver M365 solutions aligned to needs
• Establish standards, documentation, and best practices
• Act as escalation point for complex issues and mentor team members
• Track usage and adoption to drive continuous improvement

Principal Systems Engineer

Affiliate Manager

• Act as direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
• Build relationships with investigators and site staff.
• Support on request country specific feasibility and/or site pre-qualification and qualification activities.
• Manage country and site level TMF issues ensuring documents’ First Time Quality (FTQ).
• Develop strategy to configure, distribute, collect, and review high quality country and/or site specific documents.
• Customize, review, and negotiate country/site specific Informed Consent Forms (ICF).
• Prepare and submit IRB/IEC and MoH/RA applications, resolving conflicts.
• Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.

Site Activation Partner

Compliance

• Work on a variety of assignments, diverse product types for clients
• Creating opportunity for clients throughout the product lifecycle
• Sharing scientific, technical, regulatory, and/or commercial expertise
• Leading teams of respected SMEs
• Meeting new situations and learning
• Provide mentoring and guidance to other RS employees

Senior Vice President, Technical - Clinical Regulatory Affairs

Clinical Operations

• Direct line management of FSP Clinical Operations managers and staff, and oversight of Client accounts.
• Supporting FSP Clinical Operations business objectives, ensuring on-time/high quality deliverables.
• Resourcing Client projects with qualified staff, and working to retain and develop staff.
• Promoting new business by participating in project bids and Client presentations as appropriate.
• Responsible for execution and oversight of Program Management activities related to one or more programs.
• May serve as central point of contact (POC) for and between Senior Management and key Client personnel for contracted FSP Clinical Operations activities.
• Plans and manages logistics, infrastructure, and resources related to FSP services to meet Client needs/timelines/ deliverables.
• Collaborates with Client to implement and operationalize short- and long-term strategies.
• Develops and manages Communication and Escalation plans/processes, as applicable.
• Oversees Client Governance as required; prepares/presents at meetings as applicable.
• Oversees performance management of staff who support contracted FSP activities and collaborates with FSP Clinical Operations Management to ensure staff are technically proficient and able to satisfy Client expectations and deliverables.
• Manages compliance with Client Key Performance Indicators (KPIs), utilizing applicable tools and systems to collect, track, and analyze associated data.
• Leads Client-specific FSP meetings with internal program team, ensuring that contractual requirements related to FSP Clinical Operations activities are met and monitored on an ongoing basis.
• Oversees and/or manages issue escalation and resolution, including corrective and Preventive Actions (CAPA) development when necessary.
• Manages and oversees FSP Clinical Operations functional and associated management staff dependent upon Client structure and services.
• Coordinates and manages resourcing process including hiring, selection, and onboarding/offboarding of staff which may include development of interview tools, as well as conducting interviews with potential candidates.

Associate Director, FSP Clinical Operations / FSP Program Lead

Software Engineer

• Effectively designs and codes R and SQL programs for assigned project(s), consistently meeting project objectives
• Clean and validate Real-World Data (RWD) to ensure consistency and reliability
• Implement programming based on RWE protocols using a variety of RWD sources, including Optum and Flatiron
• Leverage advanced statistical and epidemiological methodologies to deliver robust and reliable analyses
• Create, review, and approve programming plans at both study and project levels
• Demonstrate advanced knowledge of programming, epidemiological methodology implementation, and system development life cycle concepts
• Maintain clear documentation of analytical programming and operational definitions to support reproducible and auditable RWE studies
• Develop dashboards, reports, and presentations to effectively communicate findings
• Collaborate with study team members to meet study timelines and recurring reporting deadlines

Senior RWE/RWA Programmer

• Responsible for managing and maintaining regulatory data, supporting EMA submissions, and ensuring compliance with European regulatory requirements.
• Hands-on experience with xEVMPD, Veeva Vault RIM, and lifecycle management activities across authorized and investigational medicinal products.
• Validate, maintain, and manage regulatory data for medicinal products in compliance with EMA guidelines.
• Perform xEVMPD submissions via EMA Gateway and monitor acknowledgements using Register/AgXchange, EV Web, and Veeva Vault.
• Support Product Lifecycle Management (PLM) activities, including variations, renewals, and regulatory updates for CAPs and non-CAPs.
• Execute Post-Marketing Surveillance (PMS) and Product Update Information (PUI) activities, ensuring timely and accurate submissions.
• Prepare and manage EMA deliverables such as eAF (electronic Application Forms) and eSMP (electronic Summary of Product Characteristics).
• Handle submission and maintenance of regulatory documents including SmPC, PIL, and Health Authority communications.
• Work on regulatory procedures such as xEVMPD, IDMP, CTA, MAA, and lifecycle management activities.
• Utilize Veeva Vault RIM for submissions, tracking, and regulatory data management.
• Ensure accurate data aggregation, mapping, and consistency across multiple regulatory systems and documents (RIMS, DMS).
• Collaborate with cross-functional teams to ensure compliance and timely regulatory submissions.

Senior Regulatory Affairs Associate

• Maintenance (from initiation through close out): Act as Parexel’s direct contact with assigned sites
• Assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites
• Build relationships with investigators and site staff
• Facilitate and support site with access to relevant study systems
• Evaluate if on-site staff assignment is still accurate
• Address and resolve issues at sites
• Collect, review, and approve updated/amended site documentation
• Monitor and maintain compliance with ICH-GCP and applicable international and local regulations
• Ensure timely and accurate completion of project goals
• Maintain a positive, results-orientated work environment.

Clinical Research Associate I – II

Medical writer

• Author clinical documents for submission to regulatory authorities
• Gather, review, analyze, and evaluate resources for clinical document preparation
• Ensure work is complete and of high quality before team distribution
• Serve as primary client contact for medical writing projects
• Attend and complete mandatory training

Medical Writer I

• Author Clinical Documents including model informed consents and clinical study reports
• Ensure document quality and adherence to regulatory guidelines
• Manage medical writing projects and client communications
• Provide medical editing review of documents
• Attend and complete training as required

Operations

• Supports Global Study Managers and the larger study management delivery of the study by leading specific parts of the project
• Oversees the preferred Contract Research Organization (pCRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) for assigned studies
• Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution
• Ensures compliance to relevant global and local, internal and external requirements, and regulations
• Provides protocol level guidance and support to responsible local study team members as applicable

Country Study Operations Manager I

Supply Chain

• Supporting the development and applying the study specific supply chain strategy including the sourcing and distribution strategy for clinical trial supply
• Plan and monitor inventory according to strategy, quantities and forecast
• Develop supply schedule and provide feedback to depots
• Perform UAT in close cooperation with e-Logistics team
• Ensure study/project timelines, budgets and efficiencies are met
• Collaborate with preparation and participate in and follow up on audits/inspections

Senior Clinical Study Administrator

Study Start-Up Manager

Clinical Research Associate II

Senior Manager, Medical Writing Services

Principal Systems Engineer

Site Activation Partner

Senior Vice President, Technical - Clinical Regulatory Affairs

Associate Director, FSP Clinical Operations / FSP Program Lead

Senior RWE/RWA Programmer

Senior Regulatory Affairs Associate

Clinical Research Associate I – II

Medical Writer I

Medical Writer I

Country Study Operations Manager I

Supply and Logistics Coordinator