Parexel

Compliance

• Coordinate, track, and manage all artwork changes within Veeva RIMS from receipt of new artwork change requests until approval
• Create and manage Artwork Projects in Veeva RIMS for customer artwork changes
• Review artwork in accordance with client procedures
• Manage changes to the lifecycle of artwork components in Veeva RIMS
• Create Artwork Projects and AW Briefs in Veeva RIMS for technical changes without regulatory impact
• Create new SKUs in Veeva RIMS
• Update, maintain, and QC Artwork Project details, ensuring accuracy of: AW Implementation dates, Related object fields, Document metadata fields (as applicable)
• Request Print Proofs and run comparator reports when needed
• Manage new component item codes
• Liaise with client stakeholders to progress artwork changes as applicable
• Communicate implementation dates to manufacturing sites
• Escalate issues as required to ensure artwork development deadlines are met
• Provide information to Quality Assurance (QA) EN and Partners regarding approval and implementation dates of new artwork
• Attend project-related meetings

Regulatory Affairs Associate – Artwork Coordinator

Inside Sales

• Set the global sales strategy and drive execution across all regions and SBUs.
• Lead a global organization responsible for generating high-value opportunities, including multi-billion-dollar proposal pipelines.
• Partner with Executive Management to align commercial strategy with corporate objectives.
• Build and scale best-in-class sales processes, tools, and methodologies.
• Establish social selling as a core competency across the global sales organization.
• Cultivate senior-level relationships with key clients and industry influencers.

Global Head, Inside Sales

Affiliate Manager

• Responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Client standards.
• Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation.
• Register investigator sites and Client stakeholders in Client registries and systems as required.
• Work directly and interact with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in Shared Investigator Platform (SIP) or reviewing/completing critical information Sheet.
• Take the lead to resolve issues or concerns and timely escalation of Site issues where applicable.
• Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines.
• Manage and coordinate with other supporting roles to ensure timely site activation and operational activities.
• Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study.
• Assist with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

Site Activation Partner I

ServiceNow

• Design, build, and customize ServiceNow applications, including forms, UI actions, scripts, and flows
• Create custom applications, record producers, workflows, and integrations
• Enhance and support modules such as ITSM, CMDB, Discovery, Asset, ITOM, and ITAM
• Build and maintain integrations using REST, SOAP, MID Server, OAuth, and Basic Auth
• Manage roles, groups, ACLs, and platform permissions
• Gather requirements and convert them into technical solutions

ServiceNow Developer

• 문서 조정 및 절차와 커뮤니케이션을 조정하며 수입 및 수출 관리
• 세관 및 정부기관의 규정에 따라 모든 수입/수출 활동을 수행할 수 있도록 보장
• 프로젝트 회의에 참석하여 진행 상황 업데이트
• 수입/수출 면허 신청서를 준비하고 제출

Global Trade Compliance Specialist

Business Operations

• Support Clinical Operations through contract management, financial planning, and data analysis
• Serve as a key liaison between FP&A, Procurement, Suppliers, Clinical Operations, and Vendor Management teams
• Partner with FP&A, Procurement, Suppliers, and Clinical Operations for contract and purchase order management
• Collaborate with Clinical Portfolio Management Vendor Management to manage contracts and purchase orders
• Support budget development, forecasting, and long-term planning activities
• Generate variance analyses for projects, identifying trends and potential issues
• Provide decision-making support through data-driven insights and recommendations
• Develop forecasting models and scenario planning tools
• Create and distribute regular reports including FTE reporting and financial variance reports
• Ensure reporting accuracy and timeliness to support business decisions
• Lead or contribute to data mapping projects and maintain data integrity across systems
• Identify opportunities for process automation and efficiency improvements
• Drive continuous improvement initiatives within Clinical Business Operations

Business Operations Analyst

Research Analyst

• Manage all site management and supervisory activities in the assigned oncology studies.
• Work with industry leaders and subject matter experts.
• Mentor junior CRAs.
• Work with world-class technology.
• Have great opportunities to travel, work from home, and meet new people in the drug development process.

Senior Clinical Research Associate – Oncology

Operations

• Establish and streamline SKDL processes to increase efficiency and implement analytical tools to advance departmental goals.
• Support SKDL operations, including samples, kits, and data processes, ensuring integrity and completeness for database locks.
• Use technical tools/systems and programming languages to systematically clean data, including processing confidential data according to guidelines.
• Programmatically aggregate and extract key information from operational reports
• Possess knowledge of structured data, such as entities, classes, hierarchies, relationships, and metadata, with the ability to perform data mapping
• Support processing of informed consent forms (ICFs) and ensure compliance with ICFs for internal sample handling, tracking, usage, and destruction.
• Maintain and review metrics related to clinical study samples, data, kits, and logistics.
• Lead cross-functional study teams, manage vendor relationships, and oversee clinical trial biosamples and data monitoring.
• Support clinical trial biosamples and data monitoring and completeness from collection through to disposal, per requirements of the study
• Anticipate challenges, manage dependencies, and mitigate risks across SKDL projects.
• Enhance communication with senior stakeholders and align SKDL functions with group objectives.
• Participate in vendor oversight activities, including issue escalation, metrics reviews, and performance monitoring

Laboratory Operations Programming Lead

Consultant

• Provide high-quality, timely, scientific/strategic solutions to meet client needs.
• Lead conduct and analysis of research to shape strategic recommendations.
• Manage and execute SLR tasks: screening, data extraction, protocol design, quantitative feasibility.
• Develop SLR deliverables: reports, slide decks, manuscripts, abstracts, posters.

Health Economics Consultant, Evidence Evaluation

Manager

• The Clinical Laboratory Study Manager works closely with Precision Medicine Leadership and cross-functional study teams to ensure quality samples and data are proficiently managed.
• Manage all activities related to biosample process planning and execution, including storage, shipping, and data transfer throughout the study lifecycle.
• Oversee the acquisition and testing of clinical trial samples designated for biomarker research, liaising with relevant stakeholders to assess biosample vendors, review proposals/bids, and define contractual scope.
• Works closely with data management and biostatistics leads to determine how biomarker data will be captured, blinded, transferred and reported for clinical trials.
• Provides guidance and training to clinical teams and investigative sites regarding collection, storage and shipment of biospecimens to ensure compliance with the clinical protocol.
• Manage and oversee kit inventories, clinical sample collection, tracking and data query resolution, regulatory submission documents related to kits and samples.

Clinical Laboratory Study Manager – FSP

Project Manager

• Oversees delivery of vendor system builds and system updates within budget, timelines and quality
• Manages resourcing requests to Parexel functional teams and ensures appropriate resources are assigned to study work in good time
• Collaborates with client, vendor, Parexel project teams and functional teams to create and manage timelines for delivery of vendor system builds and updates.
• Maintain good financial management practices to ensure project profitability and capturing of revenue
• Actively identifies and documents all potential changes to the clinical systems on an assigned study
• Lead delivery of vendor system changes
• Identifies inefficiencies with current processes and leads process improvements
• Utilize delegation and negotiation skills with regards to project tasks, to obtain maximum productivity and team involvement
• Responsible for successful completion of project deliverables
• Responsible for resolving study issues in a timely, proactive and effective manner
• Ensure compliance with SOPs and other relevant regulatory body directives e.g. 21 CFR Part 11, ICH-GCP
• May support pre-sales process
• Assesses and documents all project risks for potential changes to clinical systems
• Ensures any identified risks are mitigated seeking appropriate input from all stakeholders, maintaining accurate documentation, and communicating to internal and external parties as appropriate
• Primary client contact for the vendor systems on the study, manages the client relationship
• May be involved in program management and/or key account relationship management
• Manages and lead complex programs of work
• Communicates regularly and effectively with internal and external team members regarding delivery status and provides timely notification to all appropriate parties with deviations from timelines and/or deliverables
• Act as vendor system Lead in sponsor & vendor meetings
• Oversee quality review
• Review and approve validation documents
• Accountable for the documentation quality
• Accountable of the documentation filing in the eTMF
• Leads quality investigations to successful conclusion and within appropriate timeframe

Vendor Systems Project Manager – RTSM / IRT / eCOA

Artificial Intelligence

• Build AI/ML applications using Python, LLMs, TensorFlow, PyTorch, numpy & scikit‑learn
• Create intelligent agents and automation tools that support clinical research workflows
• Develop software using Python, TypeScript, SQL , and integrate with cloud technologies like Azure
• Collaborate with engineers and data scientists using GitHub and Azure DevOps
• Document your work and present your progress to project stakeholders
• Gain real-world experience in designing, testing, and deploying AI solutions

AI Intern

• Responsible to establish and maintain a group of high performing regulatory affairs professionals working in an efficient, productive and harmonized fashion to support the execution of company plans in Hong Kong.
• Closely collaborate with regional regulatory expertise in the Therapeutic Areas in both labelling and CMC aspects.
• Design, deploy and maintain processes and/ or systems to manage external stakeholders.
• Provide regulatory support, including oversight of product launch and implementation timelines to internal and external stakeholder.
• Accountable for planning, leading and delivering Hong Kong registration strategies across a broad range of company products.

Regulatory Affairs Consultant

Clinical Research

• Support moderately complex clinical study activities in support of the Clinical Trial Manager.
• Work closely with the clinical trial team to ensure trial activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's.
• May assist with vendor oversight and management with guidance.
• Identify issues in a timely manner and escalate to management as appropriate.
• Oversight of TMF
• May complete monitoring visit report review and perform co-monitoring or monitoring oversight visits.

Clinical Trial Specialist

• Lead Client Solutions & Business Development
• Act as a trusted advisor to clients on complex Regulatory Affairs challenges
• Provide cross-functional leadership for regulatory outsourcing programs
• Deliver projects on time, within budget, and to the highest quality standards
• Mentor & Develop Teams