Syneos Health

Compliance

• Build and institutionalize regulatory project management frameworks, tools, and best practices to enhance GRA-AP capability and effectiveness
• Provide oversight of GRA-AP projects and portfolios, ensuring alignment with objectives and timelines
• Coordinate and facilitate communication among regulatory affairs, project teams, stakeholders, and external partners to support project execution
• Track project progress, materials, and deliverables, proactively identifying and resolving issues to maintain project momentum
• Lead and participate in regulatory project meetings, including documenting minutes, updating project portals, and communicating outcomes to stakeholders
• Perform administrative functions to support project teams and department operations
• Assume additional duties as assigned to ensure regulatory project and portfolio success

Regulatory Associate – AdPromo

Software Engineer

• Uses R/RShiny 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
• Follow 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)
• Distributes relevant information in advance
• Ensures minutes are promptly and accurately distributed
• Follows action items through to completion, and maintains order and focus of meetings, working toward consensus
• Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business
• Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted
• Acts as the lead statistical programmer
• Directs the programming activities of other programming personnel and monitors progress on programming deliverables
• Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design
• Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities
• Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor
• Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process
• Transfers deliverables
• Performs other work-related duties as assigned
• Minimal travel may be required

Senior Statistical Programmer, R/RShiny

• Utilizes primary development tools including Medidata, Rave, Oracle OC/RDC, Oracle Inform, and/or SAS
• Generates and maintains all required documentation, including the development of specifications, programs, and validation efforts in support of annotated Case Report Forms (CRFs)
• Serves on project teams to coordinate and lead development activities for clinical programming projects
• Attends meetings, participates in discussions, uses an analytical approach to problem solving
• Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget
• Balances multiple task assignments and communicates needs to supervisor to obtain needed resources
• Provides technology support to the clinical programming staff, Project Analysts, Data Managers, etc.
• Provides application administration and technical support as the subject matter expert on core business packages
• Ensures high quality deliverables by providing senior review of study level/program level/multi study core deliveries for accuracy
• Attends sponsor audits and assists with inprogress audits
• Reviews and provide input on study budgets and monitors scope of work to actual work
• Monitors applications for workflow alerts, system errors, and performance issues
• Performs system integration activities, application updates, and user acceptance testing
• Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets
• Collaborates with clients, peers, lead programmers, project teams, and/or requestors to clarify and finalize specifications

Senior Clinical Programmer

Recruitment

• Develop customized, data-driven patient recruitment and retention strategies that align with study objectives and client expectations.
• Assess study-specific factors such as target patient population, geographical reach, protocol complexity, and site feasibility to inform strategy development.
• Collaborate with Business Development, Proposals, and internal teams to support the development of competitive and differentiated RFP responses.
• Start the development of the Patient Recruitment Plan (PRP) with the identification and documentation of potential risks related to patient recruitment and retention and proposed mitigation strategies.
• Stay informed on global regulatory requirements, cultural considerations, and industry best practices to optimize strategic recommendations.
• Partner with cross-functional teams, including operational leads, feasibility teams, and data science experts, to integrate real-world insights into patient recruitment planning.
• Engage with clients during pre-award discussions and bid defense meetings to present proposed recruitment and retention strategies.
• Represent the R&R function in strategic conversations with sponsors, ensuring that proposed solutions are aligned with client goals and industry best practices.
• Leverage real-world data, historical enrollment performance, and predictive analytics to refine patient recruitment strategies.
• Continuously monitor industry trends, innovations, and emerging technologies in patient recruitment to inform future strategies.
• Contribute to the development of best practices, case studies, and lessons learned to enhance R&R solutioning processes.
• Track and analyze proposal outcomes, client feedback, and recruitment performance data to improve future strategic recommendations

Recruitment and Retention Strategy, Nursing Experience

Financial Planning and Analysis

• Ensures the integrity of the revenue recognition policies
• Sets standards of reporting on actuals, forecasts and backlog that meet and exceed the financial reporting requirements and business needs of the therapeutic area globally
• Functionally or directly supervises a team of finance professionals who partner and support the therapeutic areas to achieve and exceed their financial targets
• Oversees management and direction of assigned accounting personnel
• Approves course of action on all management/human resources’ matters
• Recommends, develops, and maintains INCR revenue recognition principles, policy, processes, systems, practices, controls and procedures
• Records and reports project revenues for each contract type in accordance and compliant with GAAP and the Revenue recognition policy
• Ensures full compliance with monthly accounting close schedule
• Develops and improves unbilled and deferred revenue accounting and reporting
• Works closely with and takes global ownership for therapeutic areas to ensure revenue recognition policies are being followed consistently

Associate Director, Business Finance

Project Manager

• Responsible for the end-to-end planning, implementation, and oversight of electronic Clinical Outcome Assessment (eCOA) solutions across assigned clinical trials
• Act as the primary point of accountability for eCOA delivery
• Ensure systems are configured, validated, deployed, and maintained in alignment with study requirements, regulatory standards, and sponsor expectations
• Partner closely with Clinical Operations, Data Management, Biostatistics, vendors, and sponsors to deliver high quality, patient centric electronic assessment solutions
• Lead eCOA delivery activities from startup through clos-out, including requirements gathering, system build, UAT script writing, UAT conduct, ongoing maintenance
• Develop and manage eCOA project plans, timelines, and risk mitigation strategies in alignment with study milestones
• Serve as primary eCOA subject matter expert for assigned studies, providing guidance, implementing lessons learned and best practices

eCOA Project Manager, Clinical Trials, eCOA technologies

Clinical Operations

• 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.

Clinical Project Manager – Regional or Global Experience

Pricing Analyst

• Enter and update pricing changes in the pricing/budget tool for pre-award opportunities, standalone services, and change orders
• Support pricing requests by ensuring information is accurately reflected in the system according to approved inputs and guidance
• Review pricing change requests for completeness, accuracy, and consistency before making updates
• Coordinate with pricing, finance, business development, operations, and proposal teams to clarify requirements and resolve discrepancies
• Maintain accurate records of pricing updates, assumptions, approvals, and supporting documentation
• Assist with quality control checks to ensure pricing updates align with approved scope, assumptions, and business rules
• Support the preparation and revision of budgets, pricing scenarios, and change order pricing as needed
• Follow established pricing processes, approval workflows, and compliance requirements
• Help identify process gaps, data inconsistencies, or opportunities to improve pricing tool accuracy and efficiency
• Provide timely status updates on assigned pricing changes and escalate issues when appropriate

Junior Pricing Specialist

Clinical Research

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits
• 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
• 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
• Assesses site processes
• Conducts Source Document Review of appropriate site source documents and medical records
• Applies query resolution techniques remotely and on site
• Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture

Clinical Trial Manager – CTM, Argentina, Brazil, Chile, Colombia, Mexico

Analyst

• Build and maintain dashboards and reports to track key performance indicators (KPIs) related to enterprise transformation efforts.
• Maintain predictive models from disparate datasets to support strategic decisions such as revenue burn analysis, employee turnover, and headcount forecasting.
• Support the design of executive-level reporting packs, surfacing relevant trends and data insights.
• Analyze workforce, cost, and operational data to uncover drivers of performance and areas of opportunity.
• Assist in maintaining standardized data models and definitions across multiple data sources and teams.

Senior Transformation Analyst

Salesforce Developer

• Provide advanced hands-on technical leadership for Salesforce platform delivery across Syneos Health’s Service Cloud, Health Cloud, REMS, Engagement Center, and related platform capabilities.
• Lead the design, development, configuration, testing, and support of Salesforce solutions that are secure, scalable, maintainable, and aligned with Syneos enterprise architecture and regulated delivery standards.
• Serve as the day-to-day technical lead for Salesforce engineering work, partnering with architecture, business stakeholders, QA, validation, security, operations, and platform support teams.
• Help establish sustainable internal Salesforce engineering practices, including technical standards, code review expectations, production support procedures, documentation practices, and knowledge continuity across the Salesforce platform.

Senior Salesforce Engineer – Technical Lead

Full-stack Engineer

• Design and develop scalable, secure, and high-performance web applications.
• Build advanced frontend components using React.js.
• Design, develop, and maintain backend services using Python.
• Work with Node.js for backend services, APIs, and integration needs.
• Lead API design and integration using REST/JSON services.
• Mentor and guide junior developers.
• Troubleshoot complex application, performance, database, and integration issues.

Full Stack Software Developer

Medical writer

• 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, clinical study reports, informed consents, and more
• Adheres to established regulatory standards
• Coordinates quality and editorial reviews
• Acts as peer reviewer for internal team
• Provides technical support, training, and consultation

Medical Writer – Future Roles

Operations

• Develop and coordinate Phase 1 clinical research studies, ensuring all aspects of the study are meticulously planned and executed
• Implement clinical research protocols and ensure compliance with regulatory requirements, including Good Clinical Practice (GCP) guidelines
• Collaborate with principal investigators, research subjects, client teams, and clinic operations teams to facilitate smooth communication and coordination
• Plan and manage logistics and resource usage for clinical trials, including scheduling, budgeting, and resource allocation
• Track study progress and ensure alignment with project milestones, client deliverables, and budget, providing regular updates to stakeholders
• Prepare and present study reports and updates to stakeholders, including detailed analysis of study data and progress
• Ensure adherence to global and regional regulations and guidelines, staying up-to-date with any changes or updates
• Provide guidance and support to lower-level professionals and team members, fostering a collaborative and supportive work environment
• Identify and resolve any issues or challenges that arise during the course of the study, ensuring timely and effective solutions
• Maintain accurate and comprehensive documentation of all study-related activities, ensuring transparency and accountability.

Country Study Operations Manager – Sponsor Dedicated

• 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.