Syneos Health

Clinical Research

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity
• Oversees site interactions post activation through site closeout
• May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT)
• Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters
• Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables
• Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations
• Participates and presents in key meetings such as Kick Off Meeting
• Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members
• Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines
• Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities
• Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan
• Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed
• Ensures access and audit trail reviews are conducted as required
• Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality
• Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools
• Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs),Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan
• Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan
• Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans
• Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity
• Document requested revisions and approvals in CTMS
• Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines
• Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables
• Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements
• Provides solutions for obstacles in protocol execution and site management
• Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations
• Supports Inspection Readiness for clinical trial management scope
• Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks
• May develop and support execution of corrective action plans at site and study level
• Supports and completes activities to achieve data cut and lock deadlines
• Provides feedback to line managers on staff performance including strengths as well as areas for development
• May be assigned to larger, more complex trials

Clinical Trial Manager – Oncology, Homebased – Travelling Required

Project Manager

• Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements.
• Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement.
• Lead project team to ensure quality, timelines and budget management.
• Accountable for the financial performance of each project.
• Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
• Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements.
• Accountable for all project deliverables for each project assigned.
• Responsible for quality and completeness of TMF for assigned projects.
• Accountable for maintenance of study information on a variety of databases and systems.
• Responsible for study management components of inspection readiness for all aspects of the study conduct.
• Oversight for development and implementation of project plans.
• Plan, coordinate and present at internal and external meetings.
• Prepare project management reports for clients and management.
• Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
• Develops strong relationships with current clients to generate new and/or add-on business for the future.

Project Manager, Cell and Gene Therapy Experience Required

Compliance

• Performs Assembler tasks within the document publishing system, including, but not limited to, creating publications, modifying outline, assigning and transforming documents, and adding cross references.
• Performs Publishing tasks within the electronic publishing system, including, but not limited to, adding special sheets, applying rules, preparing for publishing, and publishing.
• Performs QC tasks within the electronic publishing system and QC of the published output.
• May QC materials prepared by team or client.
• May create, key, and assemble client deliverable documents and submissions using standard word processing or publishing systems and utilities (Extedo’s eCTDManager and eSUBmanager, CoreDossier, ISI Toolbox, ISI Publisher, eCTDXpress, eValidator, Acrobat and others).
• Takes lead role in preparing full application submission builds.
• Troubleshoots issues with eCTD builds and provides guidance to the entry level publishers.
• Provides assistance and guidance to entry-level publishers.
• May review documents for legibility, completeness, and accuracy.
• May log and track regulatory documents, publications, and other relevant materials.
• May organize and compile regulatory documentation, perform pagination, clean-up, and duplication tasks.
• May receive and deliver client information/documents, with significant supervision.
• May provide alternatives for completing assigned tasks.
• Prepares and assembles applications (INDs, NDAs, ANDAs, DMFs, variations, routine reports, renewals etc.) for submission to global regulatory authorities.
• Leads team to produce compliant, submission-ready PDFs from the Word source files.
• Completes report level publishing (CSR, DSUR, PSUR, Protocols).
• Completes CSR submission assembly

Regulatory Publishing Specialist – Veeva Experience Required

Business Development Rep

• driving sales growth across an assigned geographic territory or group of accounts
• blending strategic account expansion with targeted new business development
• creating tailored engagement plans and building trusted relationships
• orchestrating cross-functional solution development
• delivering both near-term results and long-term value
• leveraging data-driven insights to prioritize resources and maximize territory performance
• developing and implementing an annual sales plan for assigned markets/accounts
• prioritizing accounts and territory focus using data-informed insights
• creating and executing monthly objectives aligned to the sales plan
• managing time and resources to achieve targets
• building and maintaining strategic account plans
• proactively identifying client challenges
• collaborating with internal teams to deliver solutions
• leading the design and execution of tailored sales strategies
• driving account expansion strategies including therapeutic alignment, renewals, and next-phase opportunities
• maintaining up-to-date records of client activity, pipeline, and sales progress within CRM platforms

Senior Director, Business Development

Medical writer

• Collaborate with passionate problem solvers
• Create and update work instruction as per request management system
• Manage own workload to ensure delivery to agreed milestones
• Proactively identify risks to project delivery

Medical Writer II – Funding e-Request

Manager

• collaborate with teams to help customers achieve their goals
• innovate while working with passionate problem solvers
• contribute to the delivery of therapies to patients through strategic thinking.

Senior Site Activation Manager

• Develops and executes a comprehensive sales strategy for a defined book of business and geographic territory, balancing new client acquisition with growth of existing accounts.
• Manages an optimized territory through data-informed prioritization of time, client opportunity, and market potential.
• Identifies, engages, and nurtures key client relationships with decision-makers, influencers, and stakeholders at all levels.
• Leads the orchestration of tailored, multi-touchpoint sales strategies based on client needs, pipeline dynamics, and strategic goals.
• Drives expansion playbooks, including therapeutically aligned strategies, renewal opportunities and next-phase conversions, to deepen account value.
• Collaborates closely with cross-functional teams—including operations, therapeutic strategy, deal strategy, and delivery —to co-develop solutions that address client-specific challenges.
• Acts as a client champion internally by sharing insights on client culture, preferences, and strategic priorities to enable effective team alignment and proposal development.
• Educates clients on Syneos Health’s differentiated value proposition, clinical and commercial capabilities, and evolving service offerings.
• Conducts regular territory performance reviews, forecasts pipeline progression, and adjusts plans based on shifting client and market needs.
• Maintains up-to-date records of client activity, pipeline, and sales progress within CRM platforms such as Salesforce.
• Stays current on industry trends, competitor developments, and emerging client needs to continuously refine engagement strategies.
• Represents Syneos Health at client meetings, industry conferences, and other relevant events to build brand presence and uncover new opportunities.

• Support filtering, cleaning, migration, analysis, reporting and publication of regulatory data and information
• Performs Assembler tasks within the document publishing system, including creating publications, modifying outline, assigning and transforming documents, and adding cross references
• Compliance checking, Hyper-linking, bookmarking, rendering multiple documents to PDF, creation of external links, completion of Modules 1-5 in eCTD format, compilation of NeeS, compilation of paper submission, publishing and validation
• Performs publishing tasks within the electronic publishing system
• Performs QC tasks within the electronic publishing system and QC of the published output
• Creates, keys, and assembles client deliverable documents and submissions using standard word processing or publishing systems
• Takes lead role in preparing full application submission builds
• Troubleshoots issues with eCTD builds and provide guidance to entry level publishers
• Reviews documents for legibility, completeness, and accuracy
• Logs and tracks regulatory documents, publications, and other relevant materials
• Prepares and assembles applications for submission to global regulatory authorities

Regulatory Publishing Specialist, eCTD

• manage client relationships
• identify new business opportunities
• work collaboratively with internal teams to deliver solutions
• drive sales initiatives and achieve targets

Account Development Manager

Software Engineer

• Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
• Works to ensure that outputs meet quality standards and project requirements.
• Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings.
• Keeps project team members informed of programming progress and issues requiring their attention.
• Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.
• Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.
• Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements.
• Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
• Conducts effective internal meetings (appropriate in format, frequency and attendance).

Senior Statistical Programmer

• Lead cross-functional team meetings, vendor discussions, and site calls, ensuring timely issue resolution and seamless communication
• Independently develop and manage study timelines, project trackers, and operational deliverables
• Oversee site and vendor selection, budget planning, and resource tracking to ensure trials are executed within scope and on time
• Ensure adherence to GCP, SOPs, and country-specific regulations, while maintaining consistency across studies
• Monitor trial performance, drive risk identification and mitigation, and support resolution of operational and quality issues
• Collaborate cross-functionally with teams including regulatory affairs, clinical development, data management, and safety
• Contribute to inspection readiness, including TMF oversight, compliance tracking, and CAPA support

Project Manager II – Investigator Sponsored Research, Collaborative Studies

• Leads the clear and accurate completion of medical writing deliverables
• Manages medical writing activities associated with individual studies
• Completes a variety of documents including clinical study protocols, reports, and manuscripts
• Adheres to established regulatory standards
• Coordinates quality and editorial reviews
• Acts as peer reviewer for internal team
• Provides feedback to define statistical output requirements
• Mentors and leads less experienced medical writers

Senior Medical Writer – Sponsor Dedicated

Backend Engineer

• Collaborate with the development team to advance our company mission and contribute to the core product experience.
• Work on our client-facing technology suite which increases efficiency by connecting patients, sites, and sponsors throughout the clinical trial lifecycle
• Gather technical project requirements and specifications from clients and internal stakeholders (technical and non-technical) during the project development lifecycle.
• Own all aspect of the application, including quality, performance testing, and production support.
• Translate business rules and stakeholder requirements into project specifications that leverage internal and external systems.
• Lead the design of data ingestion and transformation systems and processes.
• Support development team by developing technical and architectural plans, generating documentation, and assembling presentation material that define project technical approaches, constraints, and milestones.
• Engage directly with technical stakeholders to communicate project updates (via in-person demonstrations, virtual calls/emails) throughout the production lifecycle.
• Run all the scrums and tech sessions

Senior Full-Stack Software Engineer – JavaScript, Node

• Design, develop, and maintain Oracle PL/SQL–based solutions to meet business requirements
• Collaborate with business analysts and stakeholders to understand requirements and translate them into efficient database and PL/SQL designs
• Develop and maintain complex SQL queries, PL/SQL stored procedures, functions, packages, and triggers to implement business logic
• Optimize database performance through query tuning, execution plan analysis, indexing strategies, and SQL optimization
• Develop and consume REST web services to fetch and push data between Oracle databases and external systems
• Support and build integrations with upstream and downstream systems, including cloud and on-premise platforms
• Review and validate solution designs to ensure all technical, performance, and integration aspects are adequately covered
• Participate in code reviews and contribute to continuous improvement of database development standards and best practices
• Mentor and provide technical guidance to junior team members in PL/SQL development and Oracle best practices
• Develop and maintain technical documentation, including data models, schema diagrams, and standard operating procedures
• Stay up to date with the latest Oracle database technologies, features, and best practices
• Perform other work-related duties as assigned

Senior Oracle PL/SQL Developer

Full-stack Engineer

• Provides advance level of designs, develops, and delivers clean maintainable solutions based on Big Data applications
• Performs the full deployment lifecycle, using Azure Cloud Technologies, including installation, configuration, initial production deployment, recovery, security and data governance for Data Lake
• Evaluates and provides technical solutions to design, develop, and support as required in a lead role for business units wishing to implement a Big Data solution
• Refines raw data into actionable insight using visualization and statistics with innovative analytics applications and systems
• Develops applications that can interact with the data in the most appropriate way, from batch to interactive SQL
• Provide advanced level technical guidance and support to development teams and clients throughout the solution lifecycle
• Troubleshoot and resolve complex issues related to Cloud based Data Lake and Data Mesh environments
• Stay current with emerging technologies and trends and recommend best practices
• Design, develop, and implement scalable and secure cloud solutions for Big Data Platforms
• Architect and optimize data pipelines using distributed cloud computing
• Develop guidelines and plans for performance tuning of a Big Data /NoSQL environment
• Implement a mixed batch/near-real time architecture to analyze, index, and publish data for applications
• Develop and implement strategies for data governance, security, and compliance
• Create and maintain comprehensive documentation for solution designs, configurations, and best practices
• Provide training and support to clients and internal teams on solution architecture
• Engage with clients to understand their business needs and deliver tailored cloud solutions
• Conduct presentations, demos, and workshops to showcase Data Lake Capabilities

Clinical Trial Manager – Oncology, Homebased – Travelling Required

Project Manager, Cell and Gene Therapy Experience Required

Regulatory Publishing Specialist – Veeva Experience Required

Senior Director, Business Development

Medical Writer II – Funding e-Request

Senior Site Activation Manager

Senior Director, Business Development

Regulatory Publishing Specialist, eCTD

Account Development Manager

Senior Statistical Programmer

Project Manager II – Investigator Sponsored Research, Collaborative Studies

Senior Medical Writer – Sponsor Dedicated

Senior Full-Stack Software Engineer – JavaScript, Node

Senior Oracle PL/SQL Developer

Senior Engineer – Azure Cloud, API, Automation, AI