Syneos Health

Safety Specialist

• Enter information into PVG quality and tracking systems for receipt and tracking of ICSR
• Assist in processing ICSRs according to SOPs and project/program-specific safety plans
• Triage ICSRs and evaluate data for completeness, accuracy, and regulatory reportability
• Enter data into the safety database
• Code events, medical history, concomitant medications, tests, indications, products, and substances
• Compile complete narrative summaries
• Identify information to query and follow up until queries are satisfactorily resolved
• Assist with timely, consistent, and accurate expedited safety reporting
• Maintain safety tracking for assigned activities
• Perform literature screening and review for safety
• Validate and submit xEVMPD product records
• Perform activities related to SPOR / IDMP
• Conduct quality review of ICSRs
• Submit relevant documents to the Trial Master File and Pharmacovigilance System Master File
• Maintain compliance with SOPs, WIs, global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project plans, and the drug development process
• Foster professional working relationships with internal and external project team members
• Participate in audits as required
• Apply Syneos Health regulatory intelligence to safety reporting activities

Safety Specialist I

Research Analyst

• Contribute to study design and methodology development
• Develop innovative approaches, frameworks and solutions to client problems
• Deliver project outputs meeting quality standards, timelines, and budget requirements
• Conduct structured literature reviews and targeted secondary research
• Participate in qualitative research activities, including patient interviews
• Analyze and interpret qualitative and quantitative real-world data
• Conduct workshops and moderate discussions
• Present results to external clients
• Contribute to study protocols, technical reports, manuscripts, scientific posters, and client presentations
• Develop and format materials using PowerPoint, Word, and Excel
• Summarize and synthesize complex clinical and outcomes data
• Support retrospective and prospective real-world studies under senior guidance
• Leverage emerging technologies, including AI-enabled tools, to improve efficiency and analytical rigor

Senior Research Associate

Contracts Specialist

• Administer contract management processes for protocol, informed consent, institution, investigator, vendor, consultant, and customer agreements at project level
• Lead or support multi-country clinical trial contracting, including negotiating and preparing contracts, budgets, and related documents
• Support country template contract and budget agreements and produce site-specific contracts
• Submit proposed contracts and budgets for sites and negotiate issues with sites, sponsors, and internal teams
• Perform quality control, arrange execution of clinical trial agreements, archive documents, and capture metadata
• Review contracts for completeness and accuracy and document corrections
• Support business development and represent site contracts/Site Start-Up at internal or customer meetings
• Project-manage ongoing contract issues and follow up on outstanding items
• Generate amended contracts and budgets, prepare contract management documentation, and streamline processes
• Track country/site contracting timelines and milestone progress in the SSU tracking system
• Collaborate with legal, finance, clinical operations, vendors, sponsors, and other internal and external stakeholders
• Facilitate contract execution by company signatories
• Maintain contract templates, site-specific files, databases, training materials, and training records
• Train and mentor less experienced staff and provide functional guidance and feedback
• Act as communication liaison regarding contract statuses and pending issues
• Monitor project financial aspects and contracted hours/tasks and escalate discrepancies
• Review and comply with SOPs and Work Instructions and ensure timesheet compliance
• Contribute to SSU training and quality assurance plans and update SOPs/WIs

Site Contracts Specialist – LATAM Experience

Manager

• Negotiate clinical trial budgets from start to finish directly with clinical sites from a Sponsor perspective
• Understand budget and contract language for Pharma & Vaccine clinical trials
• Develop and refine templates for consistency, compliance, and strategic study needs
• Lead direct negotiations with large academic institutions and other critical stakeholders
• Draft and finalize clinical trial agreements balancing business objectives with legal and operational protections
• Conduct FMV assessments and site justification reviews when initial offers are declined
• Determine when budget or language escalation is needed and secure appropriate approvals
• Prioritize and lead multiple contracting projects across several therapeutic areas
• Escalate risks, timeline impacts, or delays affecting CTA execution
• Maintain accurate and timely updates in departmental trackers and databases
• Build relationships with internal and external partners
• Support and train additional team members
• Contribute to process improvement initiatives
• Take on ad-hoc tasks and diverse projects

Site Contract Manager, II

Project Manager

• Support overall project management of clinical studies under the direction of a Project Manager Lead
• Help control project scope, schedule, and cost across single-service, full-scope, or multiple-protocol projects
• Liaise with customers, vendors, and investigative sites from proposal development through final deliverables
• Create and maintain the Trial Master File Management (TMF) Plan
• Review the TMF for quality, completeness, and inspection readiness
• Coordinate and monitor study deliverables across internal functional departments and vendors
• Assist with interim analyses, database snapshots and locks, final CSR, and study closure
• Assist with vendor identification and contracting
• Manage vendors, deliverables, scope creep, and change orders
• Support resource management and team member transitions
• Develop contingency plans and risk mitigation strategies
• Create and maintain metric reports for clients or senior management
• Support study financial performance and financial reporting
• Attend financial review meetings and assist with budget reconciliation and overrun identification
• Review and approve site and vendor invoices
• Represent the company to clients and communicate deliverable statuses
• Participate in customer proposal development
• Plan, coordinate, and present internal and external meetings
• Facilitate team training in accordance with protocol and project requirements
• Develop knowledge of the current therapeutic environment

• Lead global planning activities and operational feasibility assessments for Phase II and III clinical trials
• Guide country allocation and feasibility processes and shape global site strategies
• Develop global engagement, recruitment, and risk mitigation plans
• Lead vendor outsourcing strategy, including identification, evaluation, and scope-of-work development
• Harmonize trial processes across clinical quality, safety, investigational product management, and financial planning
• Prepare or support responses to regulatory and ethics authorities across regions
• Ensure global teams are trained, aligned, and equipped for execution
• Oversee worldwide trial operations for compliance with GCP, SOPs, and regional regulations
• Monitor patient recruitment, risks, timelines, and budgets and drive issue resolution
• Direct documentation changes, study amendments, and retraining
• Oversee global vendors, central labs, and external partners
• Coordinate biomarker, genomic, and sub-study activities
• Lead data cleaning, database lock, and trial closeout activities
• Support CTR development, registry disclosure, scientific publications, and global study communications
• Ensure completeness and accuracy of the Trial Master File across participating regions
• Provide operational and scientific insight for global study strategy
• Lead or contribute to global feasibility assessments influencing trial design and regional planning

Senior Global Project Manager – Immunology, Metabolic, Oncology

General

• Perform study activities including start-up, maintenance, and close-out with Clinical Operations team members’ oversight and guidance
• Perform eTMF functional QC and CRO oversight QC for PMS
• Upload study documents to the Trial Master File or other repositories
• Review and participate in quality assurance of data or documents
• Assist with development of documents and standard forms
• Arrange study meeting logistics and agendas, and assist with minutes
• Track and prepare study-specific information using databases, spreadsheets, and other tools
• Maintain internal Clinical Operations databases, tools, and document repositories
• Provide administrative support for study-related activities under Clinical Operations supervision
• Act as a local subject matter expert or single point of contact for a specific focus area when needed
• Interact with other departments to complete assigned tasks
• Ensure work complies with established practices, policies, processes, and regulatory requirements

Senior Project Specialist

Software Engineer

• Develop custom programming code using SAS or other software to generate summary tables, data listings, graphs and derived datasets according to statistical analysis plans and programming specifications
• Ensure outputs meet quality standards and project requirements
• Perform validation programming and resolve discrepancies with Programmers, Biostatisticians and project team members
• Keep project team members informed of programming progress and issues
• Follow applicable SOPs, WIs and relevant regulatory guidelines such as ICH
• Maintain complete, current project documentation, testing, verification and quality-control documents and programs
• Manage schedules and time constraints across multiple projects and adapt workload to changing priorities
• Develop specifications for datasets and outputs of any complexity
• Anticipate and address programming issues to support efficient programming and peer or sponsor review
• Prepare for and conduct effective internal meetings, distribute information and minutes, and track action items
• Negotiate time estimates and complete study programming activities within allotted timeframes
• Act as lead statistical programmer, direct other programming personnel and monitor deliverables
• Review Statistical Analysis Plans, mock shells, programming specifications, annotated CRFs and SAS database designs
• Participate in sponsor, kickoff and bid defense meetings as the statistical programming representative
• Mentor programming personnel through training, work review, feedback and process guidance
• Transfer deliverables and perform other assigned work-related duties

Statistical Programmer

• Use SAS or other software to develop custom programming code for summary tables, data listings, graphs, and derived datasets according to statistical analysis plans and programming specifications
• Ensure outputs meet quality standards and project requirements
• Perform validation programming and resolve discrepancies with Programmers, Biostatisticians, and project team members
• Keep project team members informed of programming progress and issues
• Follow applicable SOPs, WIs, and regulatory guidelines such as ICH
• Maintain complete, organized, up-to-date project documentation, testing, verification, and quality-control materials for inspection readiness
• Manage schedules and time constraints across multiple projects and adapt workload to changing priorities
• Develop specifications for datasets and outputs of any complexity
• Anticipate and address programming issues and define variables for peer review and sponsor/requestor acceptance
• Prepare for and conduct effective internal meetings, distribute information and minutes, and follow action items through completion
• Negotiate time estimates and complete study programming activities within allotted timeframes
• Act as lead statistical programmer and direct the programming activities of other programming personnel
• Review Statistical Analysis Plans, mock shells, programming specifications, annotated CRFs, and SAS database designs
• Participate in sponsor, kickoff, and bid defense meetings as statistical programming representative
• Mentor programming personnel through training, work review, feedback, and guidance
• Transfer deliverables and perform other assigned work-related duties

Senior Statistical Programmer

Medical writer

• Lead the clear and accurate completion of medical writing deliverables
• Manage medical writing activities associated with individual studies
• Coordinate medical writing activities within and across departments with minimal supervision
• Lead resolution of client comments
• Complete clinical, regulatory, safety, publication, and submission documents
• Adhere to regulatory standards, ICH E3 guidelines, company SOPs, client standards, templates, authorship requirements, and style guides
• Coordinate quality and editorial reviews
• Manage source documentation appropriately
• Lead team document reviews and act as a peer reviewer
• Review statistical analysis plans and table/figure/listing specifications
• Interact with clients and cross-functional teams in data management, biostatistics, regulatory affairs, and medical affairs
• Perform online clinical literature searches and comply with copyright requirements
• Identify and propose solutions to resolve issues
• Provide technical support, training, and consultation
• Contribute to internal materials, presentations, processes, standards, and capabilities
• Mentor and lead less experienced medical writers on complex projects
• Develop expertise in industry topics and regulatory requirements
• Work within budgeted hours and communicate status and changes to medical writing leadership
• Complete required administrative tasks and other assigned duties

Sponsor Dedicated Medical Writer II/Sr

• Lead the clear and accurate completion of medical writing deliverables and coordinate medical writing activities across departments.
• Lead resolution of client comments.
• Complete clinical and regulatory documents, including protocols, clinical study reports, patient narratives, investigator brochures, informed consents, plain language summaries, safety reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, manuscripts, abstracts, posters, and presentations.
• Follow ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides.
• Coordinate quality and editorial reviews; manage source documentation appropriately.
• Lead team document reviews and act as a peer reviewer.
• Review statistical analysis plans and table/figure/listing specifications, providing feedback on statistical outputs and document needs.
• Build working relationships with clients and data management, biostatistics, regulatory affairs, and medical affairs teams.
• Perform online clinical literature searches and comply with copyright requirements.
• Identify and propose solutions to issues, escalating as appropriate.
• Provide technical support, training, and consultation to staff.
• Mentor and lead less experienced medical writers on complex projects.
• Develop expertise in industry topics and regulatory requirements affecting medical writing.
• Monitor assigned project budgets and communicate status or changes to medical writing leadership.
• Complete required administrative tasks and other assigned duties.

Principal Medical Writer – Regulatory

Security Engineer

• Define, implement, and continuously improve the CTEM lifecycle across scoping, discovery, prioritization, validation, and mobilization
• Translate exposure management strategy into repeatable operating processes, decision criteria, governance routines, and measurable outcomes
• Identify maturity gaps across asset coverage, signal quality, prioritization, validation, remediation ownership, exception handling, and executive reporting
• Partner with security, infrastructure, cloud, endpoint, identity, application, architecture, and business teams to establish shared accountability for exposure reduction
• Drive structured exposure review cycles toward validated, risk-based remediation and measurable risk reduction
• Engineer and operate exposure management capabilities across infrastructure, cloud, endpoints, identity, applications, and third-party surfaces
• Maintain and enhance tooling aggregating vulnerability data, asset context, threat intelligence, and exploitability signals
• Ensure accurate asset discovery, coverage validation, and telemetry quality across the enterprise attack surface
• Drive risk- and threat-informed prioritization using exploit intelligence, threat actor activity, asset criticality, and compensating controls
• Correlate exposure data with threat intelligence and adversary TTPs
• Support zero-day and emerging threat response through rapid exposure analysis
• Define and maintain CTEM outcome metrics and build executive, operational, engineering, and audit views
• Convert technical findings into business-relevant narratives supporting prioritization, funding, architecture decisions, and remediation mobilization
• Identify recurring exposure patterns and recommend control, architecture, automation, or process improvements
• Lead exposure reduction initiatives across teams without direct reporting authority
• Facilitate remediation planning across infrastructure, cloud, endpoint, application, identity, SOC, GRC, and business stakeholders
• Build consensus on ownership, prioritization, compensating controls, exception paths, and remediation timelines
• Escalate systemic blockers with clear options, residual risk framing, and recommended decisions
• Mentor analysts and engineers while raising exposure management maturity
• Collaborate with SMEs to define mitigation strategies and/or compensating controls
• Provide leadership with clear, defensible views of exposure and residual risk
• Provide operational guidance to and oversight of managed server provider technicians

Senior Cybersecurity Engineer – Exposure Management

Procurement

• Provide assistance in Site Start-Up activities in investigator site contracts, ethics and regulatory submissions, and essential documents required for site initiation
• Support global Clinical Operations projects under oversight from the SSU Country Manager and Central and Shared Services leadership
• Ensure regulatory and site contract documentation complies with sponsor and Company requirements
• Work with internal and external team members to implement solutions for project and individual site contract problems
• Establish strong working relationships with customers, internal project teams, and sites
• Ensure relevant documents are submitted to the Trial Master File according to Company SOP and sponsor requirements

Contract Management Assistant, Spanish, Portuguese speaking

Artificial Intelligence

• Own the roadmap and delivery of end-to-end SPVG technology solutions across case intake/processing, signal, aggregate reporting, submissions, QPPV oversight, literature, and safety analytics
• Lead cross-functional execution with internal teams and external vendors/SIs; establish governance, SLAs/KPIs, and validated deployments
• Chair innovation councils with customers and partners; convert problem statements into pilots/PoCs and scale proven patterns into offerings
• Serve as solution lead on RFIs/RFPs, including reference architectures, delivery models, scope/estimation, commercial constructs, and oral/bid defenses
• Publish points of view, present at conferences/webinars, brief executives, and lead demos, workshops, and innovation sessions
• Manage a small senior team, including mentoring, portfolio planning, resourcing, budgets, and benefits realization
• Embed risk-based quality, privacy, and security by design in partnership with QA/Compliance and Data Privacy
• Design and build minimally viable AI/ML prototypes and proof of concepts, including LLM-based agents and automation solutions
• Develop or use connectors and integrations between AI tools and PV systems
• Translate PV operational challenges into working demos to validate feasibility and business value
• Partner with engineering teams to transition POCs into scalable solutions
• Design and optimize prompt frameworks and establish prompt and accuracy governance
• Refine AI outputs through testing, feedback loops, and performance monitoring
• Support AI model validation, monitoring, explainability, and risk management
• Lead and mentor AI/PV specialists

Director, Safety and PV Systems – Innovation, AI

• Lead the clear and accurate completion of medical writing deliverables
• Manage medical writing activities associated with individual studies and coordinate activities across departments
• Lead resolution of client comments
• Complete clinical and regulatory documents, including protocols, clinical study reports, patient narratives, investigator brochures, informed consents, plain language summaries, safety reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, manuscripts, abstracts, posters, and presentations
• Adhere to ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style guides
• Coordinate quality and editorial reviews
• Manage source documentation appropriately
• Lead team document reviews and act as a peer reviewer
• Review statistical analysis plans and table/figure/listing specifications
• Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams
• Perform online clinical literature searches and comply with copyright requirements
• Identify and propose solutions to issues, escalating as appropriate
• Provide technical support, training, and consultation
• Contribute to internal materials, presentations, processes, standard practices, and capabilities
• Mentor and lead less experienced medical writers on complex projects
• Develop expertise in industry topics and regulatory requirements affecting medical writing
• Work within budgeted hours and communicate status and changes to medical writing leadership
• Complete required administrative tasks and other assigned duties