Syneos Health

Compliance

• Gather new regulatory information through routine surveillance of agreed regulatory sources
• Reviews surveillance alerts and queries and determines actions to be taken
• Support ad-hoc research requests from the business and gather regulatory information for potentially new topics
• Manage Regulatory Intelligence Network list of functional SMEs
• Interacts with external and internal experts to collect country and region-specific regulatory intelligence
• Conducts searches within commercial Regulatory Intelligence databases to identify regulations and guidelines relevant for clinical regulatory intelligence

Senior Consultant, Regulatory Intelligence

Clinical Research

• 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; immediately communicates/escalates serious issues to the project team and with guidance 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
• 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
• Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets

Clinical Trial Manager I

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.
• 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.

Senior Stat Programmer, ADAM & TLF

Financial Planning and Analysis

• Serves as financial analyst for Business Unit Controller(s) and Associate Director(s) Finance
• Prepares, reconciles, analyzes and reports Business Unit(s) revenue, contracts, projects, and associated metrics
• Produces financial and other business analyses, interpretation, and investigation of data for operations for assigned projects and contracts
• Ensures all reporting activities are accurate and prepared within established timelines
• Supports Business Unit Controller in recording revenue each month for Unit, Fee for Service and Fixed Price contracts
• Loads project budgets into Oracle/Revenue Wizard and maintains key member lists (project set up) and other project data in Oracle and associated systems and schedules
• Drafts project level actual versus budget/forecast variance analysis monthly as well as monthly reports for distribution in analyzing monthly results
• Drafts monthly forecasting of financial results (backlog)
• Meets established deadlines for Revenue and Backlog submittals
• Timely preparation of project close out reconciliations
• Reviews, with assistance, executed Work Orders and Change Orders for bonus or other anomalies
• Works closely with Business Unit Controller to capture, assess and consolidate results
• Drafts key reports such as annual cost and expense budgets, cost rates, cost and expense forecasting, monthly utilization, headcount, revenue backlog analysis, and/or gross profit for assigned area
• Updates predefined reports
• Attends project meetings as applicable to support assigned areas
• Monitors the overall health of assigned projects including but not limited to revenues, gross profit, receivables, and unbilled amounts as well as project close outs and reconciliations

Project Financial Analyst II

Product Adoption Specialist

• Partner with business leaders to translate strategic priorities into adoption objectives and align learning strategies with organizational goals
• Design and deliver targeted change and adoption plans — including communication, learning roadmaps, coaching, training, and operations support — leveraging AI-enabled tools and blended learning formats
• Apply principles to reduce resistance, foster buy-in, and create role-specific, action-oriented learning experiences that build proficiency and confidence
• Develop mechanisms to measure adoption readiness, quality, and compliance against KPIs; analyze feedback to adapt learning content and strategies as needed
• Draft foundational content, communications, training content, and other tools as appropriate
• Communicate progress, milestones, and success stories, collaborating with Corporate Communications to drive awareness and reinforce engagement
• Provide support through rapid interventions, risk mitigation strategies, and reinforcement of desired behaviors via coaching, recognition, and ongoing support
• Support multiple internal projects simultaneously, ensuring consistency, effectiveness, and alignment with change management best practices

Learning & Adoption Specialist – Project Specialist

Data Scientist

• Design, develop, and program methods, processes, and systems to consolidate and analyze unstructured, diverse “big data” sources to generate actionable insights and solutions for client services and product enhancement
• Interact with product and service teams to identify questions and issues for data analysis and experiments
• Create, document, and manage templates and standard operating procedures for algorithms, code repositories, rules, manuals, and other assets
• Develop and code software programs, algorithms, and automated processes to cleanse, integrate and evaluate large datasets from multiple disparate sources
• Assist team in identifying meaningful insights from large data and metadata sources, interpreting and communicating insights and findings from analysis and experiments to product, service, and business managers
• Have broad expertise or innovative knowledge, use skills to contribute to the development of company objectives and principles and to achieve goals in creative and effective ways
• Work on significant and unique issues where analysis of situations or data requires an evaluation of intangibles
• Manage configuration, curation, and cataloging of internal and external tech and data resources and ‘always-on’ data vendors to ensure timely product delivery and innovation
• Mentor and coach junior team members across the business

Senior Data Scientist

• Design, develop, and program methods, processes, and systems to consolidate and analyze unstructured, diverse “big data” sources
• Interact with product and service teams to identify questions and issues for data analysis and experiments
• Create, document, and manage templates and standard operating procedures
• Develop and code software programs, algorithms, and automated processes
• Assist team in identifying meaningful insights from large data and metadata sources
• Interpret and communicate insights and findings
• Manage configuration, curation, and cataloging of internal and external tech and data resources
• Mentor and coach junior team members

Principal Data Scientist

Accountant

• Maintains accurate accounting records in compliance with US and local (as applicable) Generally Accepted Accounting Principles (GAAP)
• Perform required financial controls and analysis
• Assist with leading the GL team
• Assists with ensuring accurate and timely monthly, quarterly and year-end close
• Assists with ensuring financial records are maintained in compliance with accepted global policies and procedures as well as in accordance with generally accepted accounting principles in the United States (US GAAP) and local GAAP (as applicable)
• Assists with ensuring compliance with process control narratives to meet Sarbanes-Oxley Internal Controls objectives and maintains appropriate process documentation
• Alert management to any discrepancies between written processes and current procedures, so that written procedures can be updated
• Reviews, maintains, and prepares detailed journal entries, account reconciliations, and supporting schedules to the general ledger accounts as well as other controls required to comply with Sarbanes-Oxley
• Prepares monthly intercompany account reconciliations and required journal entries
• Ensures invoices are sent to intercompany partners
• Performs appropriate analysis of expenses ensuring accurate coding, adequacy of accruals, and resolves accounting discrepancies and irregularities
• Facilitates positive relationships with General Ledger (GL) team members including international accounting personnel as well as other departments
• Participate in cross functional teams as needed
• Integrates new accounting requirements into company policy and participate in implementation efforts for new accounting standards
• Identifies best practices and investigates root causes of fundamental issues and problems and recommends solutions
• Documents and analyzes current accounting procedures
• Identifies opportunities to streamline and improve the accounting process and recommend more efficient procedures
• Obtains and maintains a thorough understanding of the general ledger structure and assists in maintaining Oracle systems to manage the general ledger and sub ledgers
• Leads special projects to enhance technology or to resolve issues raised by other departments
• Provides training to new and existing staff as needed
• Ensures a timely year end audit by assisting with all aspects of audit deliverables and inquiries
• Participates in ensuring that statutory requirements are met, as applicable and requested

Senior Accountant

• Use 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
• Provide technical expertise and leadership in the development of statistical programs
• Collaborate with statisticians and other stakeholders to understand and address their programming needs
• Acts as the lead statistical programmer.
• Directs the programming activities of other programming personnel and monitors progress on programming deliverables
• Ensure the accuracy and integrity of data and statistical outputs
• Troubleshoot and resolve programming issues and challenges
• Mentor and train junior programmers and other team members
• Contribute to the continuous improvement of programming processes and tools
• Design and implement efficient programming solutions to meet project requirements
• Conduct code reviews and provide constructive feedback to ensure high-quality programming deliverables
• Stay updated with the latest advancements in statistical programming and incorporate relevant techniques into practice

Principal Statistical Programmer

Medical writer

• Leads the completion of complex medical writing deliverables
• Manages medical writing activities ensuring quality and timelines
• Completes various clinical documents required for studies
• Advises on data presentation and quality standards
• Reviews documents for technical issues
• Represents the medical writing department on clinical study teams

Principal Medical Writer

Research Analyst

• 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 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.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
• 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.
• 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.

Clinical Research Associate I/II – Sponsor Dedicated – ONC, Gen Med

Director

• Provides leadership, direction, and management to FSP 360 functional teams
• Provides training, consultation and oversees quality related to operating activities of assigned staff
• Develops and fosters strong, collaborative relationships with customers
• Solicits feedback from customer PoC (s) for continuous improvement of service delivery
• Responsible for delivery and compliance with agreed-upon KPIs
• Collaborates with local Talent Acquisition (TA) teams and identifies future customer resourcing needs
• Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs)
• Responsible for partnering with internal and external stakeholders to drive and oversee customer growth strategies
• Responsible for active management of team members’ performance
• Supports team members’ professional development through coaching

Associate Director, FSP 360

• Collaborate with passionate problem solvers
• Innovate as a team to help customers achieve their goals
• Develop custom programming code to generate summary tables and data listings
• Ensure outputs meet quality standards and project requirements
• Perform validation programming
• Manage scheduling and time constraints across multiple projects
• Prepare for internal meetings and contribute ideas
• Conduct effective internal meetings

Senior Statistical Programmer – SDTM

• Collaborates with representatives from other functions to plan, execute and analyze all biomarker aspects (including genomics) of clinical studies or biomarker studies in the role of the biomarker statistician and assumes the role of project biomarker statistician under guidance of an experienced statistician
• Develops the Biomarker Evaluation Plan for the study as appropriate, ensuring overall consistency within and between projects
• Provides statistical input in clinical development discussions, and usage of AI and ML approaches
• Facilitates the overall organization and coordination of statistical activities regarding biomarker research and development activities for specific studies and projects
• Conduct and design advanced data analysis for genomics and biomarker statistics, including statistical programming, and design complex analysis algorithms.
• Assumes responsibility for the production and accuracy of the Biomarker Evaluation Report with respect to statistical deliverables and interpretation of the results
• Works independently at routine and complex statistical questions, modeling and tasks
• Develops and implements standard processes for the analysis of routine (parts of) biomarker assessments

Principal Biostatistician – Biomarker

Medical Director

• Oversee psychiatric clinical operations
• Collaborate with multidisciplinary teams
• Ensure compliance with industry regulations
• Develop treatment protocols and guidelines