Syneos Health

Clinical Operations

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance
• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient
• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues

Clinical Country & Site Associate – Clinical Trial Manager

Contracts Specialist

• May lead multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
• Produces site-specific contracts from country clinical trial agreement (CTA) template.
• Reviews and owns site-specific contracts from country template.
• Submits proposed CTA and investigator budget for site review.
• Negotiates budget and contract with site and via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues.
• Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
• Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
• Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
• Generates amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions.
• Works closely with Site Contract Service Center and Legal to harmonize site contract to reflect sponsor's master service agreement terms.
• Works closely with SSU lead, Clinical Operations and Finance to validate the load of departmental budgets and corresponding backlog.
• Identifies possible contract or process operational risk and proactively works within the team to provide solutions.
• Establishes strong working relationships with SSU lead, customer and internal project teams.
• Escalates deviations to department leadership and/or Site Contract Service Center and/or Legal Department.
• Provides support to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
• Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time.
• Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.
• Maintains and actively supports review and development of contract templates, budget templates and site specific files and databases.
• Serves as key communication liaison between site contracts staff and internal and external customers.
• Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues.
• Prepares correspondence as necessary.
• Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs), and ensures quality of team work products.
• Maintains and updates training material for site contract team.

Senior Site Contracts Specialist – Sponsor Dedicated

QA Engineer

• Analyze project requirements and design comprehensive test cases
• Execute manual and automated tests
• Collaborate with developers to resolve issues
• Maintain and update automated test scripts
• Participate in Agile ceremonies

QA Tester – Playwright, TypeScript

Clinical Research

• Independently negotiating and managing Clinical Trial Agreements (CTAs), CTA amendments, and site budgets for U.S. and Canadian clinical research sites
• Drafting, cloning, reviewing, and negotiating site-specific CTAs from approved country templates
• Leading contract and budget negotiations directly with investigative sites while partnering with Sponsor stakeholders until all issues are resolved
• Applying approved CTA fallback language and budget negotiation parameters with minimal supervision
• Maintaining accurate contract negotiation status and milestones within the Sponsor's clinical trial tracking system
• Preparing amendments, revised budgets, and supporting documentation throughout the study lifecycle
• Performing quality control reviews to ensure contracts are complete, accurate, compliant, and execution-ready
• Coordinating contract execution and maintaining all required documentation and metadata within electronic repositories
• Partnering closely with Clinical Operations, Site Start-Up, Finance, Legal, and Site Contract Service Center teams to ensure efficient study activation
• Identifying contractual or operational risks early and proactively driving solutions
• Tracking contracting timelines, deliverables, and project milestones to support study start-up goals
• Serving as a trusted point of contact for internal teams, investigative sites, and Sponsor stakeholders
• Supporting customer meetings, business initiatives, and continuous process improvements
• Mentoring junior team members and contributing to SOPs, training materials, and quality initiatives
• Monitoring contract-related project metrics and escalating issues when appropriate

Senior Site Contracts Specialist – Clinical Trial Contracts

Project Manager

• Creates and maintains the Trial Master File Management (TMF) Plan.
• Routinely reviews the TMF to ensure quality, completeness and inspection readiness
• Coordinates and monitors the activities associated with study deliverables across all applicable internal functional departments and vendors.
• Assists with activities associated with interim analyses, database snapshots and locks, final CSR and study closure
• Assists with identification of and contracting with approved vendors, as necessary
• Provides vendor management, inclusive of ensuring key deliverables are met, potential scope creep is identified and change orders are developed, as necessary
• Assists with development and implementation of change orders
• Assists with resource management and team member transition by collaborating with appropriate Resource Managers and ensuring detailed Transition Plans are developed and implemented efficiently
• Develops contingency planning and risk mitigation strategies to ensure meeting or exceeding study milestones
• Creation and maintenance of metric reports, inclusive of data collection from multiple sources, for delivery to client or senior management
• Assists with overall financial performance of the study by interacting with internal functional departments or vendors to obtain required metrics for financial reporting
• Attends financial review meetings to assist with reconciliation and identification of budget overrun
• Reviews and approves invoices from sites or vendors and to the client
• Participates in representing the company to the client, ensuring satisfaction levels are met and statuses of deliverables are communicated effectively.
• May participate in Customer proposal development
• In collaboration with the Project Team, will plan, coordinate and present at internal and external meetings
• Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training
• Develops knowledge of current therapeutic environment

Project Manager I, RWE

Research Analyst

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance
• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate
• Demonstrates diligence in protecting the confidentiality of each subject/patient
• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
• Assesses site processes
• Conducts Source Document Review of appropriate site source documents and medical records
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
• Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
• Verifies site compliance with electronic data capture requirements
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security
• Verifies the IP has been dispensed and administered to subjects/patients according to the protocol
• Verifies issues or risks associated with blinded or randomized information related to IP
• Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness
• Reconciles contents of the ISF with the Trial Master File (TMF)
• Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan
• Supports subject/patient recruitment, retention and awareness strategies
• Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
• Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met
• Must be able to quickly adapt to changing priorities to achieve goals / targets
• May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
• May provide training or mentorship to more junior level CRAs

Senior Clinical Research Associate – Sponsor Dedicated

• Contribute to study design and methodology development
• Develop innovative approaches, frameworks and solutions to client problems
• Deliver project outputs that meet established quality standards, timelines, and budget requirements
• Conduct structured literature reviews and targeted secondary research to support RWE initiatives
• Participate in qualitative research activities, including patient interviews, to generate actionable healthcare insights
• Analyze and interpret qualitative and quantitative ‘real-world’ data for deliverables
• Conduct workshops and moderate discussions
• Present results to external clients
• Contribute to the development of: Study protocols, Technical reports, Manuscripts and scientific posters, Client presentations
• Develop and format materials using PowerPoint, Word, and Excel
• Summarize and synthesize complex clinical and outcomes data into clear, structured findings
• Support retrospective and prospective real-world studies under senior guidance
• Demonstrate openness to leveraging emerging technologies, including AI-enabled tools, to improve efficiency, analytical rigor, and personal productivity

Senior Research Associate

• Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions
• Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
• Creates and assists with maintenance of Trial Master File (TMF) and project files, including participation in file audits
• Prepares and maintains site manuals, reference tools and other documents
• Maintains, updates, and inputs clinical tracking information into databases
• Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client
• Manages shared mailbox, processes site requests and routes correspondence appropriately
• Coordinates the ordering, packaging, shipping and tracking of site supplies and materials
• Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items
• May handle receipt, tracking and disposition of Case Report Forms and Queries
• Maintains overall awareness in the field of clinical research by completing all necessary and assigned training

CTA, Clinical Operations Specialist

Safety Specialist

• Collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
• Act with a drug development mindset, applying experience and expertise to understand customer needs.
• Work alongside the brightest minds in the biopharmaceutical industry to deliver therapies to patients.

Senior Safety Submission Specialist

Medical Director

• Manages a project as Project Manager overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and regulatory requirements.
• Acts as primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer’s and the Company's contractual agreement.
• Leads clinical team to ensure quality, timelines and budget management.
• Accountable for the financial performance of assigned projects.
• Accountable for all project deliverables for assigned projects and/or project regions.
• Coordinates activities and deliverables of all project conduct partners and proactively identifies and manages issues.
• Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
• Responsible for project management components of inspection readiness for all aspects of the project conduct, including Trial Master Files.
• Provides oversight for development and implementation of project plans in accordance with Controlled Documents.
• Independently prepares, coordinates, and presents project material at internal and external meetings.
• Directs the activities of assigned Project Support staff; line manages and mentors other project management team members and clinical staff; facilitates team building and communication.
• Prepares project management reports for clients and management.

Clinical Senior Project Manager, Associate Director – Global role, Multisponsor

• Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
• May lead (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
• Provides support to SSUL to agree on country template contract and budget.
• Produces site-specific contracts from country template.
• Provide support in submissions for proposed contract and budget for site.
• Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues.
• Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
• Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
• Provides supports to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
• Work with Contract Managers and team members with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues.
• Support in generating amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; and initiates and introduces creative ideas and solutions.
• Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time.
• Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.
• Facilitates the execution of contracts by company signatories.
• Maintains contract templates and site specific files and databases.
• Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs) and ensures quality of team work products.
• Maintains and updates training material for site contract team.
• Acts as a communication liaison between site contracts staff and internal and external customers.
• Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues.
• Prepares correspondence as necessary.
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.

Site Contracts Specialist – Clinical Trials

Reviewer

• Responsible for execution of Central Report Review activities on the study
• May support development of annotated visit reports
• Reviews the content and quality of site and central monitoring documentation
• Ensure deliverables are provided according to company and/or sponsor specifications
• Documents observations noted during reviews and ensures protocol deviations or action items are reported as necessary

Report Reviewer

Clinical Specialist

Clinical Operation Specialist

General

• Provide operational support related to management of reference materials and matrices.
• Provide operational support related to the receipt, verification, inventory control, distribution, sending and disposition of study samples.
• Prepare the samples for analysis.
• Keep an inventory of supplies used to manage samples and order supplies when needed.
• Assist with the maintenance, operation and support of sample storage equipment and the associate monitoring system.
• Archive documents associated with the management of study samples.

Sample Management Specialist – End-to-End Sample Management Process

• The CTL provides leadership and direction to the trial team.
• Collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.