Syneos Health

Clinical Research

• Review assigned protocols and related documentation for accuracy, feasibility, timing, and resources
• Prepare and maintain Investigator Site Files and/or Trial Master Files
• Participate in timelines, start-up meetings, Investigator Meetings, Site Initiation Visits, and sponsor discussions
• Coordinate study start-up activities, clinic logistics, schedules, team training, source documents, CRFs, laboratory workbooks, staffing, and study supplies
• Confirm regulatory and contractual documentation before study start
• Support the Principal Investigator with delegation logs, daily task management, visit calendars, and monitor visits
• Advertise, recruit, and screen potential study participants
• Perform study activities in accordance with Good Clinical Practices
• Manage multiple clinical trials simultaneously and protect participant safety
• Collect and enter study data; complete Case Report Forms and submit data on time
• Coordinate screening and assist with informed consent
• Facilitate study-data audits and respond to auditor data-clarification inquiries
• Coordinate clinic visits, including admission, dosing, randomization, discharge, and follow-up
• Provide on-call support when applicable
• Screen eligibility and oversee, coordinate, and/or perform study-drug administration as delegated
• Monitor study activities for compliance with protocol, SOPs, and applicable regulations
• Manage adverse-event reporting, study logs, trackers, quality control, and monitor findings
• Coordinate QC, monitor, CRF, and other findings through resolution
• Oversee study close-out documentation, deviation reporting, CRF completion, TMF updates, logs, supply returns, IRB reports, and archiving
• Monitor participant compliance and escalate participant or study issues
• Prepare for and participate in sponsor, monitor, and QA audits
• Provide timely project-status updates to Project Managers and sponsors
• Collaborate on process improvement, SOP creation/revision, meetings, and company initiatives
• Coordinate and perform regulatory activities, including protocol, consent, amendment, and yearly renewal submissions when requested
• Report trial-related adverse events and maintain study files
• Perform other assigned work-related duties

Clinical Research Coordinator II, Oncology

Nurse

• Provide pediatric/adolescent research nursing services
• Deliver clinical research services directly in patients’ homes
• Work on clinical research trials across diverse therapeutic areas and study phases
• Perform phlebotomy, venipuncture, and blood handling and processing
• Administer subcutaneous injections and intravenous therapies
• Conduct ECGs, observations, and specimen collections
• Perform cannulation
• Work with central venous access
• Complete detailed data
• Travel to patients’ homes and manage patient visits
• Work independently and as part of a wider team

Per Diem Pediatric/Adolescent Research Nurse

Medical writer

• Lead clear and accurate medical writing deliverables and manage writing activities across departments
• Lead resolution of client comments
• Complete protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal 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 and manage source documentation
• 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 resolve 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
• Develop expertise in industry topics and regulatory requirements
• Monitor assigned project budgets and communicate status and changes to medical writing leadership
• Complete administrative tasks and other assigned duties
• Minimal travel may be required, less than 25%

Senior Medical Writer – Regulatory Focus

Associate

• Drive and support overall project management activities for clinical trials
• Plan and execute elements of clinical trials in partnership with the Project Lead
• Ensure projects adhere to timelines and are delivered within budget
• Coordinate internal resources and third parties/vendors for efficient project execution
• Conduct ongoing analysis of project performance
• Maintain and distribute study-specific financial reports and contribute to study financial health
• Document project scope and objectives with relevant stakeholders
• Lead communication between project team members regarding project status and changes
• Document and escalate project risks and issues and drive timely resolution
• Maintain systems, project management tools, and methodologies
• Drive quality assurance activities, audit preparation, internal review, and issue resolution

Project Associate – Ideal Opportunity for CTA or Project Specialist

Project Manager

• Support strategies for site training, patient enrollment (recruitment and retention), and patient and researcher engagement activities
• Partner with program leads and cross-functional teams on strategic initiatives from planning and timeline development through execution and follow-up
• Coordinate timelines, facilitate review meetings, and distribute training and educational deliverables
• Support internal systems and communications throughout project execution
• Maintain platforms and systems supporting patient engagement initiatives
• Upload and maintain eTMF records in compliance with applicable requirements
• Collaborate to improve standards, processes, tools, and best practices
• Communicate with external stakeholders, including clinical trial participants and healthcare professionals
• Coordinate activities with external vendors, patients, and healthcare professionals
• Provide technical support to integrate engagement processes across functions
• Support practical, scalable strategies within clinical programs

Project Manager I – Patient Engagement and Co-Design

• Lead clear and accurate completion of medical writing deliverables
• Manage medical writing activities for individual studies and coordinate activities across departments
• Lead resolution of client comments
• Complete clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and scientific meeting presentations
• Adhere to regulatory standards, SOPs, client standards, approved templates, authorship requirements, and style and formatting guides
• Coordinate quality and editorial reviews and manage source documentation
• Lead team document reviews and act as an internal peer reviewer
• Review statistical analysis plans and table/figure/listing specifications
• Collaborate with clients and colleagues in data management, biostatistics, regulatory affairs, and medical affairs
• Perform online clinical literature searches
• Identify and propose solutions, escalating issues 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
• Monitor project budgets and communicate status and changes to medical writing leadership
• Complete administrative tasks and other assigned duties
• Travel minimally, if required

Senior Medical Writer, Publications

Support Engineer

• Conduct comprehensive analysis of business requirements and translate them into technical specifications
• Design and develop technical solutions meeting business objectives and stakeholder needs
• Perform systems analysis and identify areas for improvement or optimization
• Collaborate with software developers, engineers, and IT professionals to integrate new systems and technologies
• Lead and manage IT projects from initiation to completion within scope, budget, and timelines
• Develop project plans, timelines, and resource allocation strategies
• Monitor project progress, identify risks, and implement mitigation strategies
• Facilitate communication and coordination among project team members and stakeholders
• Understand business user needs and provide technical guidance and support
• Liaise between technical teams and business stakeholders
• Prepare and present technical reports, proposals, and documentation
• Oversee maintenance and support of existing IT systems and applications
• Identify and troubleshoot technical issues and provide timely resolutions
• Ensure system security, data integrity, and performance optimization
• Implement and enforce best practices for system administration and support
• Research emerging technologies and industry trends
• Conduct feasibility studies and recommend and implement innovative technology solutions

Senior Technical Analyst

• Lead clear and accurate completion of medical writing deliverables
• Manage medical writing activities for individual studies with minimal supervision
• Coordinate medical writing activities within and across departments
• Lead resolution of client comments
• Complete clinical study protocols and amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations
• Adhere to ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides
• Coordinate quality and editorial reviews and manage source documentation
• Lead team document reviews and review documents as needed
• Act as peer reviewer for internal teams
• Review statistical analysis plans and table/figure/listing specifications
• 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, escalating issues 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
• Monitor project budgets and communicate status and changes to medical writing leadership
• Complete required administrative tasks
• Perform other assigned work-related duties

Senior Medical Writer – Clinical Document Writing

Operations

• Analyze current-state processes to identify gaps, risks, inefficiencies, and root causes
• Develop future-state workflows, process documentation, and role clarity recommendations
• Support process improvement frameworks, tools, templates, and best practices
• Develop and maintain detailed program and project plans covering scope, deliverables, milestones, resources, dependencies, budgets, and success measures
• Support program governance through status materials, decision and escalation logs, forums, and role clarification
• Coordinate cross-functional workstreams and manage risks, issues, actions, decisions, interdependencies, changes, and resource constraints
• Prepare program reporting for EPMO leadership, sponsors, and governance bodies
• Facilitate project and workstream meetings, document decisions and commitments, and follow up on actions and deliverables
• Build relationships with business stakeholders to understand needs, validate findings, and prioritize improvement opportunities
• Collaborate on solution implementation, including communications, training, process documentation, testing, and change adoption
• Review and strengthen transformation business cases by validating assumptions, assessing feasibility, identifying dependencies, and ensuring measurable benefits
• Support performance measurement and benefits tracking through KPIs and reporting
• Partner with technology, operations, and business stakeholders to assess AI, automation, and workflow enablement opportunities
• Champion continuous improvement and support organizational change adoption

Manager, Strategic Process Improvement – Programs

Contracts Specialist

• Lead multi-country projects, including negotiating and preparing contracts, budgets, and related documents for industry-sponsored clinical trials
• Produce and review site-specific contracts from country clinical trial agreement templates
• Submit proposed CTAs and investigator budgets for site review
• Negotiate budgets and contracts with sites, Site Contracts Service Centre, SSUL, and sponsors
• Perform quality control, arrange execution of CTAs, archive documents, and capture metadata
• Administer contract management processes and coordinate related protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents
• Generate amended contract and budget documents and prepare project contract-management documentation
• Work with Site Contract Service Center and Legal to harmonize site contracts with sponsor master service agreement terms
• Collaborate with SSU lead, Clinical Operations, and Finance to validate departmental budgets and backlog
• Identify contract or process risks and develop solutions; escalate deviations as appropriate
• Support business development and represent site contracts/SSU at internal or customer meetings
• Track country/site contracting milestones and comply with forecasted timelines using the SSU tracking system
• Collaborate with legal, finance, and clinical operations teams on legal and budgetary issues
• Maintain contract templates, budget templates, site-specific files, and databases
• Serve as communication liaison regarding contract statuses and pending issues; prepare correspondence
• Train and mentor less experienced staff and maintain training materials
• Participate in discussions about company goals, departmental objectives, and project aims
• Facilitate contract execution by company signatories
• Monitor project financial aspects and contract hours/tasks; escalate discrepancies
• Review and comply with SOPs and WIs, update training records, and ensure timesheet compliance

Senior Site Contracts Specialist

Financial Planning and Analysis

• Support the Business Unit Controller
• Record monthly revenue for unit, fee-for-service, and fixed-price contracts, or ensure revenue is submitted by the Project Manager
• Load revenue into the Oracle Fusion accounting system
• Provide commentary on material forecast variances
• Obtain and load project forecasts
• Ensure invoices are raised according to client specifications
• Perform monthly project reconciliation of invoices versus billing
• Ensure project closeouts are performed timely
• Save project trackers centrally for SOX purposes
• Escalate project issues quickly
• Review accounts receivable aging
• Assist project teams with project setup, revenue calculation, billing, and predefined reports
• Attend meetings with Project Managers as needed

Project Financial Analyst I

Compliance

• Lead and support submissions in Latin American markets for MAAs and life-cycle management procedures
• Provide local expertise as a member of the Global Regulatory Affairs team
• Drive and coordinate regulatory strategy and local regulatory activities in Latin America
• Provide regional regulatory expertise for geographical expansion
• Track Health Authorities’ requests and relevant new local regulations
• Maintain current knowledge of local requirements and communicate regulatory changes to senior management
• Lead cross-functional Vertex teams through submission planning, preparation, submission, and review
• Prepare responses to regulatory questions
• Prepare timelines and create submission binders in Veeva
• Keep submission and correspondence files up to date
• Act as local expert for regulatory queries from medical, supply chain, and other functions
• Ensure work complies with regulatory requirements and company policies and procedures

Regulatory Strategist – International, Manager

• Create and maintain content plans within Veeva Vault RIM
• Translate Smartsheet timelines into Microsoft Project and Veeva Vault RIM
• Assist with planning, managing, and tracking regulatory submissions
• Support Vertex Global Submission Managers with project management activities, tasks, and tracking
• Assist with coordination and communication of regulatory submissions to Vertex Publishing
• Explain difficult information through written and verbal communication
• Adapt to changing requirements and priorities while meeting firm deadlines

Senior Regulatory Consultant – LATAM

General

• Support site and investigator evaluation activities
• Collect, review, and assess regulatory, compliance, quality, and performance information
• Support site selection, study start-up, and ongoing study delivery
• Identify potential risks and escalate concerns
• Collaborate with internal stakeholders to ensure timely resolution
• Follow project direction from the designated country start-up advisor and Site Activation Manager
• Compile and/or review essential document packages for site activation
• Collect essential documents from sites
• Prepare and submit central and local ethics committee applications, regulatory authority applications, and other local approval submissions under supervision
• Prepare ongoing submissions, amendments, periodic notifications, and safety notifications as required
• Liaise between investigational sites and functional leads
• Oversee the end-to-end site activation process at country and site level
• Support site selection based on clinical trial requirements
• Assist with country-template and site-specific contracts and budgets
• Support contract and budget negotiations under supervision
• Assist with quality control, execution of clinical trial agreements, document archival, and metadata capture

Site Activation Specialist I

Medical Billing and Coding

• Encode terms reported as adverse events and medical history
• Encode prior and concomitant medications using industry-accepted dictionaries such as MedDRA and WHODrug
• Perform coding in accordance with 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