Syneos Health

Medical Billing and Coding

• Encode terms reported as adverse events and medical history, as well as prior and concomitant medications, using industry-accepted dictionaries such as MedDRA and WHODrug
• Perform coding according to departmental coding conventions and company SOPs
• Generate queries to clarify potentially discrepant data
• Assist with data coding consistency reviews and SAE reconciliation as needed
• Collaborate with medical monitors and Clinical and Data Management team members to ensure timely processing according to project timelines
• Assist in interdepartmental training of new staff as needed

Medical Coding Specialist – Clinical Coder II

Associate

• Perform site management activities in compliance with Company and Sponsor SOPs and Work Instructions
• Assure compliance with local regulations and applicable GPP and/or ICH-GCP guidance
• Conduct site management activities according to the Scope of Work, Site Management Plan, and relevant guidelines
• Identify sites and contact them regarding study participation, contact details, and required documents
• Qualify and select appropriate sites for assigned studies
• Perform site start-up activities with study start-up and regulatory teams
• Conduct remote and on-site monitoring throughout all study stages
• Review Investigator Site Files for accuracy, timeliness, and completeness and reconcile them with Trial Master Files
• Document site activities and enter data into tracking systems
• Support subject/patient recruitment, retention, and awareness strategies
• Protect subject/patient confidentiality
• Review assigned-site data, assist with data-query resolution, and follow up on missing data
• Maintain timely communication with site staff and project teams and escalate issues for resolution
• Maintain clinical tracking and management systems
• Ensure assigned sites are trained and compliant with study requirements
• Provide site and project guidance for audit readiness and support audit preparation and follow-up
• Attend and participate in Investigator Meetings and sponsor meetings
• Collaborate with Sponsor affiliates, medical science liaisons, and local country sponsor staff
• Manage site-level activities and communications to meet project objectives, deliverables, and timelines
• Identify and communicate out-of-scope activities to the Clinical Operations Lead
• Attend, contribute to, and present at study and department meetings

Site Management Associate

Clinical Trial Associate

• Monitor clinical supply inventory levels, trends, and potential supply risks
• Support supply forecasting, metrics reporting, and inventory tracking activities
• Process requisitions and coordinate procurement of comparator drugs and ancillary supplies
• Coordinate clinical supply shipments, depot transfers, and site return logistics
• Track shipment delivery schedules and assist with temperature excursion investigations and resolution
• Maintain study documentation, including Expected Document Lists (EDLs), comparator records, and Electronic Trial Master File (eTMF) documentation
• Support QA/QP release requests, inspection readiness activities, and pack-and-label reconciliation processes
• Assist with Interactive Response Technology (IRT) activities, including user access management, alert monitoring, and User Acceptance Testing (UAT)
• Conduct product compatibility research and maintain related data in approved databases and tracking tools
• Manage clinical supply system records, shared mailboxes, and documentation uploads within Veeva
• Perform administrative and support activities assigned by the Clinical Trial Supplies Manager or Project Lead
• Operate independently with minimal day-to-day oversight and may coordinate activities of other Clinical Trial Supplies Associates

Senior Clinical Trial Supplies Associate

Manager

• Serve as Lead Contract Manager within Syneos Health’s Clinical Solutions team
• Collaborate with customers and colleagues in Functional Service Provider or Full-Service environments
• Understand customer needs and represent them in shaped solutions
• Take initiative and challenge the status quo in a competitive, changing environment
• Perform additional tasks, duties, and responsibilities assigned by the Company

Lead Contract Manager

QA Engineer

• Conduct audits to assess compliance with applicable regulations, company policies, SOPs, work instructions, contracts and project-specific requirements
• Plan and conduct assigned Syneos Health audits
• Write and issue audit reports, clearly communicating findings to auditees and relevant management
• Review responses to audit findings for appropriateness and completeness
• Close assigned audits
• Prepare for and host or support customer audits
• Assist senior QA personnel in hosting or supporting Regulatory Authority Inspections
• Perform other work-related duties as assigned

Auditor II, QA – Good Pharmacovigilance Practice

Clinical Operations

• Manage interdisciplinary clinical research programs as Project Manager
• Ensure compliance with GCPs, SOPs, and regulatory requirements
• Act as the primary liaison between the Company and the Customer through project launch, conduct, and closeout
• Lead clinical teams to ensure quality, timelines, and budget management
• Manage the financial performance and deliverables of assigned projects and/or project regions
• Coordinate project conduct partners and proactively identify and manage issues
• Maintain project information in databases and systems
• Maintain and evaluate project progress using timelines and tracking/analysis tools
• Manage project components of inspection readiness, including Trial Master Files
• Oversee development and implementation of project plans
• Prepare, coordinate, and present project materials at internal and external meetings
• Direct and mentor Project Support staff, project management team members, and clinical staff
• Prepare project management reports for clients and management
• Implement resource strategies, contingency plans, and risk mitigation strategies
• Participate in bid defense meetings
• Develop current-client relationships to generate new or add-on business
• Maintain awareness of therapeutic environments and drug development trends
• Train and support new Project Managers and facilitate team training
• Line manage project management team members and clinical monitoring staff as required

Clinical Project Manager – Regional/Global, Mexico & Argentina

• Review contract language and budgets for completeness and accuracy, ensuring corrections are appropriately made and documented
• Maintain internal project trackers with accurate and timely information
• Use sponsor-provided fallback language to negotiate site contracting language
• Negotiate study budgets within approval parameters and follow escalation processes
• Attend weekly internal and external progress meetings and provide updates and next steps on active contract negotiations
• Collaborate with stakeholders to align contract execution dates and site activation timelines
• Establish and maintain positive relationships with internal and external stakeholders
• Identify contractual or operational risks early and proactively drive solutions
• Prepare contract and budget escalations as required
• Draft and finalize study start-up documents, templates, and start-up plans
• Prepare and lead kick-off meetings with the study team
• Schedule contract and budget preparation and overview meetings
• Prepare final contracts once negotiations are complete and escalations are approved
• Participate in pilot and stretch projects aligned with role and sponsor initiatives
• Support clinical studies from start-up to activation for a dedicated sponsor

Site Contract Specialist II – Contract Manager II, Sponsor Dedicated

• Conduct audits to assess compliance with applicable regulations, company policies, SOPs, work instructions, contracts, and project-specific requirements
• Host and support customer audits and regulatory inspections in accordance with QA SOPs and work instructions
• Plan and conduct assigned Syneos Health audits
• Write and issue audit reports, clearly communicating findings to auditees and relevant management
• Review responses to audit findings for appropriateness and completeness
• Close assigned audits
• Prepare for and host or support customer audits
• Assist senior QA personnel in hosting or supporting Regulatory Authority Inspections
• Perform other work-related duties as assigned

Auditor II, QA, GCP Exp Required

Clinical Research

• Provide site management oversight, clinical monitoring, and central monitoring deliverables focused on patient safety, protocol/GCP/regulatory compliance, and data integrity
• Oversee site interactions from activation through closeout, including recruitment and investigator payments
• Identify clinical trial risks and develop risk mitigations
• Review study scope, budget, protocol content, and contractual obligations
• Monitor operational data, metrics, reports, timelines, quality, and budget risks
• Participate in and present at key meetings, including Kick Off Meetings
• Serve as an escalation point for investigator site communications and interact with principal investigators and site staff
• Coordinate handoffs with Study Start Up, Patient Recruitment, and Data Management teams
• Develop and maintain clinical study tools and templates, including Clinical Monitoring Plans
• Ensure CTMS, dashboards, and other systems are configured and available, including user acceptance testing
• Coordinate study-team training on protocols, CRFs, dashboards, SOPs, plans, data, and timelines
• Oversee CRA and Central Monitor resourcing, site assignments, conduct, and delivery risks
• Review monitoring documentation and ensure timely delivery to company and sponsor specifications
• Provide clinical deliverable and risk status updates to clients, project management, and leadership
• Support inspection readiness, corrective action plans, data cut, and database lock deadlines
• Provide performance feedback to line managers
• Coordinate clinical activities across complex trials or portfolios
• Coach and mentor CTMs on clinical delivery, project risks, and action implementation

Clinical Trial Manager II

Contracts Specialist

• Administer all contract management processes for protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at project level
• Lead, with supervision, multi-country projects involving negotiation and preparation of contracts, budgets, and related clinical-trial documents
• Support agreement on country template contracts and budgets
• Produce site-specific contracts from country templates
• Support submissions and negotiations for proposed site contracts and budgets
• Perform quality control, arrange execution of CTAs, 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
• Manage ongoing contract issues and follow up on outstanding issues
• Generate amended contract and/or budget documents and streamline contract, proposal, and internal processes
• Track contracting milestones and comply with forecasted country/site timelines 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, and training materials
• Train and mentor less experienced staff and provide functional guidance
• Communicate contract statuses and pending issues and prepare correspondence
• Monitor basic project financial aspects and contract hours/tasks and escalate discrepancies
• Comply with SOPs and Work Instructions, maintain training records, and ensure timesheet compliance

Site Contracts Specialist

Financial Planning and Analysis

• Produce and present client reporting and facilitate customer-facing financial discussions
• Prepare, interpret, and analyze financial data, business metrics, and ad hoc reports for global management
• Prepare annual cost and expense budgets, cost rates, cost and expense forecasts, monthly utilization, headcount, revenue backlog analysis, and/or gross profit reports for the assigned area
• Develop and produce monthly financial reports and commentary and other financial analysis and metrics for senior management
• Review reporting timeliness, accuracy, and efficiencies and recommend methods for improving results
• Serve as a key contact for interpretation and investigation of financial results in the assigned area
• Provide financial insights into business growth trends and profitability
• Assist Finance management with miscellaneous projects as directed by the supervisor
• Develop and deliver financial reporting, controls, and procedures to ensure accurate and timely reporting
• Update and cost study budgets based on updated trial specifications

Project Financial Analyst II

• Provide site management oversight, clinical monitoring and central monitoring deliverables, focusing on patient safety, protocol/GCP/regulatory compliance and data integrity
• Oversee site interactions from post-activation through site closeout, including patient recruitment and investigator payments
• Identify clinical data, process and protocol execution risks and implement risk mitigations
• Review study scope of work, budget and protocol content; ensure clinical project teams understand contractual obligations
• Identify and escalate risks to timelines, quality, budget and contracted scope
• Participate in and present at key meetings, including Kick Off Meetings
• Serve as an escalation point for investigator site staff communications and support site visits when needed
• Collaborate with Study Start Up, Patient Recruitment, Data Management and other functional leaders to meet study milestones
• Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan
• Ensure CTMS, dashboards and other systems are configured, available and subject to required UAT and audit trail reviews
• Coordinate training for study teams on protocols, CRF completion, dashboards, SOPs, plans and timelines
• Oversee CRA and Central Monitor resourcing, site assignments and team conduct
• Ensure quality and visibility of clinical monitoring, central monitoring and site management deliverables
• Review oversight dashboards and clinical trial systems including CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS and central monitoring dashboards
• Ensure monitoring strategy, CMP/SMP and risk plan compliance
• Review site and central monitoring documentation and ensure timely delivery and approvals
• Interact with clients and functional departments; provide status updates and solutions for protocol execution obstacles
• Support inspection readiness for clinical trial management scope
• Oversee CRAs and Central Monitors, assess compliance, identify emerging risks and support corrective action plans
• Support activities required to achieve data cut and lock deadlines
• Provide performance feedback to line managers

Clinical Trial Manager I – Sponsor-dedicated

Software Engineer

• Develop custom programming code using SAS or other software to generate summary tables, data listings, graphs, and derived datasets
• Ensure outputs meet quality standards and project requirements
• Perform validation programming and resolve discrepancies with programmers, biostatisticians, and project team members
• Follow applicable SOPs, WIs, and relevant regulatory guidelines such as ICH
• Maintain complete, current project documentation, testing, verification, and quality-control materials
• Manage schedules and priorities across multiple concurrent projects
• Develop specifications for datasets and outputs of varying complexity
• Conduct internal meetings, distribute information, and follow action items through completion
• Deliver concurrent programming projects on time and provide risk-mitigation plans
• Lead statistical programming activities and direct 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 the statistical programming representative
• Mentor programming personnel through training, work review, feedback, and guidance
• Serve as a technical expert on clinical drug development, industry standards, and electronic submission requirements
• Establish SOPs, guidelines, policies, and procedures with biostatistics and statistical programming personnel
• Develop programming tools and macros for standardization and efficiency
• Provide guidance and training on CDISC Standards
• Perform compliance reviews of CDISC deliverables, including SDTM and ADaM specifications and datasets and DEFINE.XML
• Participate in industry standards organizations and communicate updates on standards
• Transfer deliverables
• Perform other work-related duties as assigned

Principal Statistical Programmer

Project Manager

• Provide customer-focused management of Clinical Surveillance & Training (CST) scoped services to support scientific integrity and data quality in clinical trials
• Liaise with customers, vendors, and investigative sites from project start-up through final customer deliverables
• Represent the CST team on small to large-sized studies or programs
• Interact with functional groups, vendors, license holders, Key Opinion Leaders, and Sponsors
• Serve as Project Lead in CST stand-alone projects and Functional Lead in full-scope or multiple-protocol projects
• Manage CST deliverables for scoped-service vendors, scale license holders, and/or KOLs
• Manage license procurement, scale translation requirements, and paper scale worksheet development
• Manage CST service-related documentation and templates, including development and testing of the Study Training and Engagement Portal
• Ensure quality, timely delivery, and implementation of CST services
• Develop and maintain study-specific CST plans in accordance with SOPs and Work Instructions
• Contribute to functional project plans
• Provide status updates to internal and Sponsor project teams, including delivery risks and timeline delays
• Serve as the central point of contact for CST-related project issues
• Create and maintain CST metric reports for client delivery
• Attend internal and Sponsor meetings as the lead CST representative
• Maintain project documentation and ensure complete and accurate filing in the Trial Master File
• Identify risks and develop mitigation plans
• Participate in Sponsor, internal, or agency audits and inspections
• Manage CST scope, out-of-scope activities, overburn, revenue recognition when delegated, invoice management, and/or KOL contracts and management
• Plan, manage, and request CST resources and provide resource updates
• Train and mentor internal team members

Project Manager, eCOA Manager

• Serve as the main point of contact for healthcare providers, sites, and patients
• Coordinate and monitor non-interventional studies, including pregnancy registries and retrospective chart reviews
• Collect, review, and manage study data through electronic case report forms (eCRFs)
• Ensure data accuracy and adherence to protocols and regulations
• Conduct remote interviews, data entry, and data review
• Maintain essential documentation and audit readiness throughout the study
• Track data trends, perform data cuts, and contribute to analysis and reporting
• Support non-interventional clinical research studies and patient registries