Parexel

Data Engineer

• Manage Projects & Technology
• Lead and implement Data Receipt Agreements with vendors in collaboration with cross-functional teams
• Program and establish import procedures for data ingestion using SAS or alternative technologies (e.g., Workbench)
• Design and implement reconciliation checks to ensure accurate data transfer
• Program offline listings and custom reports to provide valuable insights on external data
• Aggregate data across all sources and manage data structures, missing values, and programming errors
• Review data outputs and provide strategic insights to study teams and clients
• Ensure first-time quality on all deliverables
• Negotiate electronic data timelines and ensure adherence through active project management
• Monitor project resourcing, identify scope changes, and resolve technical issues
• Coordinate and lead programming teams to successful project completion within timelines and budget
• Manage deployment of data management technology for offline listing creation
• Act as SME and technology owner for data management offline listing platforms
• Maintain comprehensive supporting documentation in accordance with SOPs, Guidelines, and Work Instructions
• Ensure traceability and regulatory compliance across all study activities
• Document deviations and communicate them to project teams
• Support Initiatives & Continuous Improvement
• Participate in creating standards through tools (SAS macros), libraries, and processes
• Develop and implement project-specific tools and improvements
• Lead or drive global initiatives related to processes and new technologies
• Mentor staff and provide relevant training
• Assist project teams in problem resolution and technical support
• Maintain and expand regulatory knowledge within the clinical research industry
• Serve as point of contact for clients and internal stakeholders on electronic data matters
• Participate in bid defense meetings
• Independently contribute ideas on technology and data engineering to support business development

Principal Clinical Data Engineer

Data Scientist

• Lead a small clinical study or co-lead a larger study or studies with moderate guidance.
• Be able to support several clinical studies with minimal guidance.
• Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies.
• Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
• Be able to perform a thoroughly detailed review of eCRF data requirements.
• Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
• Develop data edit check specifications and run data listings as required.
• Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards.
• Able to resolve EDC system issues with team members.
• Develop the Data Management Plan for a clinical study.
• Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications.
• Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries.
• Perform reconciliation of header data from external data sources against the clinical database.
• Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines.
• Assist in database upgrades/migrations including performing User Acceptance Testing.
• Able to maintain study workbooks and data management files.
• Perform database lock and freeze activities per company SOPs.
• Participate in regular team meetings and provide input when appropriate.
• Provide input into the development of data management SOPs, Work Instructions, and process documents.
• Assist with the training of new employees and/or contractors.
• Collaborates with cross-functional teams to design and implement effective data collection strategies, ensuring high-quality data capture and timely resolution of data queries throughout the clinical trial lifecycle.

Clinical Data Manager – FSP

Medical writer

• The Senior Medical Writer is responsible for the development of medical writing deliverables that support the clinical regulatory writing portfolio
• Preparing/Updating/Merging RMPs/Company Core-RMPs (CC-RMPs)
• Managing scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Update Reports (PSURs)
• Conducting critical appraisal and systematic review of literature with a focus on background epidemiology
• Performing aggregate report compliance activities including quality review
• Coordinates and liaises with the members of Study Management Team (SMT)
• Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs provided by the client
• Responsible for the end-to-end signal management process

Senior Medical Writer – Regulatory Writing

Research Analyst

• Contributes to the selection of potential investigators.
• Trains, supports and advises Investigators and site staff in study related matters.
• Confirms that site staff have completed and documented the required trainings appropriately.
• Actively participates in Local Study Team (LST) meetings.
• Drives performance at the sites and ensures timely resolution to study-related issues.
• Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
• Ensures data query resolution in a timely manner.
• Prepares for and collaborates with the activities associated with audits and regulatory inspections.

Senior Clinical Research Associate – Oncology

Medical Director

• Medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial
• Provide medical expertise and medical oversight from the Trial Design Outline to the Clinical Trial Report
• Ensure timely preparation of high medical quality clinical trial protocols
• Contribute to trial risk-based quality management by defining medically relevant data and related risks integrated into the quality and risk management plan
• Co-author Clinical Quality Monitoring plans
• Perform ongoing reviews of medical data

Medical Monitor – Study Physician – Medical Director

Associate

• Drafting & negotiating contracts — clinical study agreements, service agreements, team member agreements, and related documents.
• Interpreting site feedback within local legal and business frameworks to guide internal decision‑makers.
• Ensuring compliance with ICH‑GCP, local laws, and internal guidelines.
• Acting as the communication hub between internal teams, site staff, and external partners.
• Managing the full contract lifecycle — from first draft to final signature and archival.
• Building strong relationships with clinical trial sites and internal stakeholders.
• Spotting risks early and collaborating with the Site Contract Lead to resolve them.
• Tracking progress in real time and keeping teams informed.
• Driving process improvements to make contracting faster, clearer, and more efficient.

Site Contracts Associate I/II, Spanish, Portuguese Speaker

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

Analyst

• Responsible for direct site facing contract and budget negotiations through contract execution with assigned clinical investigator sites including initial agreements and amendments
• Manage the Per-Subject Cost (PSC) process for assigned studies
• Manage escalation and resolution for budget and non-legal term issues from other ICL or preferred Contract Research Organizations (pCRO)
• Collaborate with other lines to plan site contracting timelines though start up
• Exercise good judgment in balancing the risks to the sponsor in making budget and contractual decisions against the impacts to client clinical trial timelines
• Follow processes to develop, negotiate, track, and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trials
• Work with partners to develop and oversee the global site budget process
• Work with clinical trial sites and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parameters
• Lead study level site contracting activities and act as primary study point of contact for site contracting issues and timelines on assigned studies
• Partner with Legal and other divisions to manage escalations in the site budgeting and contracting space
• Partner with Legal, Finance, pCRO and other divisions to identify and implement areas of improvement in the site contracting space
• Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface
• Collaborates with invoicing specialists and/or invoice service provider to ensure alignment with Investigative Site contracting and compensation requirements
• Interacts with clinical site contracts & legal contacts, client and partner legal team, study management, site payments team, peer site contracting colleagues, and CRO site contracting teams
• Contributes to design, development and implementation of major business initiatives or special projects where required

Investigator Contracts Lead – Contracts & Budgets Analyst

• Define and drive global labeling strategy across foundational and non-foundational markets (US, EU, AU, CH, DE).
• Lead creation, revision, and management of core labeling documents, including Core Data Sheet (CDS), USPI, EU SmPC, Global Patient Leaflet, and Target Label Profile.
• Align labeling content and strategy across U.S., EU, and global regulatory teams; facilitate timely endorsement of labeling decisions by senior leadership.
• Interpret clinical and scientific data to inform labeling content and product claims; identify strategic risks and opportunities.
• Remain current with global labeling regulations and provide training to internal stakeholders.
• Chair and manage Labeling Review Committee (LRC), Global Labeling Committee (GLC), and CCDS Working Team—set agendas, drive decisions, and ensure timely implementation.
• Oversee operational labeling activities, including EU/US artwork coordination, EMA linguistic reviews, and U.S. SPL submissions.
• Support regional implementation of CDS updates and monitor compliance across markets.
• Review and approve direct-to-consumer and marketing advertising, medical education, and social media content for compliance.

Senior Regulatory Affairs Consultant – Regulatory Labeling Strategist

Solutions Engineer

• Design and implement API-led connectivity solutions using MuleSoft Anypoint Platform to integrate internal and external clinical systems
• Develop and maintain scalable, reusable APIs and integration flows supporting clinical trial data exchange (EDC, CTMS, eTMF, IRT, and sponsor-facing platforms)
• Monitor, troubleshoot, and optimize MuleSoft integration performance and reliability
• Collaborate with business stakeholders to identify automation opportunities and translate them into technical workflows
• Participate in code reviews, testing, and deployment processes to ensure high-quality deliverables

Integration Engineer

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.
• Responsible to support the development of study level plans.
• 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, ICD Customisation

• Manage post-approval regulatory activities, including variations, renewals, and compliance with country-specific requirements.
• Partner with cross-functional teams to ensure timely submissions and maintain regulatory dossiers.

Regulatory Affairs Consultant – Local Regulatory Affairs Operations

Manager

• Reviewing of the vendor and category related specific sections of the protocol, ensure vendor expertise is leveraged when refining specifications towards Final Protocol
• Contributing to development of Study Specification Worksheet (SSW) to facilitate bid process and selection of Vendors
• Quote/Proposal review in collaboration with procurement (and vendor)
• If required, support contract negotiations
• Vendor budget review of final quotes
• Accountable for Vendor cost control, budget review, invoice reconciliation and PO close-out
• Supports program overview by providing study demands to VCE
• Ensures all submission documents are provided by vendor, as required, to countries participating in a study
• Works closely with trial and monitoring teams to understand site requirements for study participation
• Ensures changes to country and site plans are consistently shared with vendors and VCE for start-up, resupply and close out
• Supports amendment of vendor contracts with Procurement team
• Optimizing a frontloaded and timely study start-up process in support of a timely site readiness
• Vendor service excellence at study level, ensures vendors meet quality and service level standards in their service delivery for the trial
• Acts as escalation point for vendor-related query management
• Pro-actively creates and maintains vendor related risk maps with contingency plan for documentation
• Follow-up with countries and Hubs for their vendor-related risks and issues
• Document issues identified with vendor oversight / performance in sponsor’s internal tool and implements and monitors corrective actions
• Escalates issue if required to the Vendor Category Expert VCE
• Drive root cause analysis of supplier performance issues and look for trending
• Supports the implementation of standards, templates, tools, and processes for vendors for defined categories in collaboration with the VCE
• Using Unified Vendor Portal (UVP) to manage vendor service delivery
• Supports practice leaders in improvement projects and learning loops
• Collaborate across the sponsor’s departments to provide data for vendor qualification efforts
• Review and approve invoices against activity
• In partnership with the vendor, develop site and monitor training material, and attend/support training if needed

Vendor Start Up Manager – IRT

• Oversee both client management and deliverables of clinical trials
• Provide line management and individual team member development
• Responsible for the success of clinical trials and programs across several accounts
• Maintain and develop relationships with assigned customers
• Provide leadership as the 'go to person' for issue resolution
• Help obtain new business and deliverables on time and on budget

Director, Project Management – Clinical Trials, Oncology

• Supporting the Executive Director in leading enterprise wide quality compliance, governance, operational process excellence, vendor governance and risk management functions across Parexel’s global Data & Technology (D&T) organisation.
• Providing strategic and operational oversight for governance frameworks, Quality Management System (QMS) alignment, SDLC governance, supplier oversight, risk management and compliance by design practices supporting regulated and non-regulated technology environments.
• Serving as a senior leader responsible for strengthening operational discipline, inspection readiness, regulatory confidence and enterprise governance maturity while enabling modern, scalable and agile technology delivery.
• Supporting enterprise audit, regulatory inspection readiness, inspection coordination, audit responses and remediation activities.
• Owning and continuously improving QMS processes, SOP governance, controlled document lifecycle management and associated standards, templates and work instructions.
• Supporting enterprise SDLC governance, change management, release management and operational control processes across the technology lifecycle.
• Driving standardization, harmonization, process simplification and compliance by design across governance and delivery processes.
• Leading vendor qualification, governance, oversight and risk management for suppliers, cloud providers, strategic technology partners and outsourced delivery teams.
• Defining and maintaining supplier governance strategies, technical agreements, service expectations, performance monitoring and risk frameworks aligned to regulatory and operational expectations.
• Developing, maintaining and continuously improving D&T quality and operational risk frameworks, including criteria, tolerance, appetite, dashboards and executive-level reporting.
• Leading proactive risk identification, escalation, mitigation, governance assessment and continuous improvement activities across regulated technology environments.
• Acting as a key member of the Quality Leadership Team and partnering closely with D&T, Quality, Regulatory, Clinical, Security and Operational stakeholders.