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.
• This may include patient recruitment, investigator payments or other related activities.
• 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/CeMs) 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.
• This may include accompanying CRA team members to sites for observation or conflict resolution.
• 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
• This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA).
• 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.
• 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 or may coordinate clinical activities for a team of CTMs across a portfolio of projects
• May coach and mentor CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation.

Clinical Trial Manager

Project Manager

• 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 maintaining 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
• Attends project kick-off meetings to capture and process relevant data for set up of newly awarded projects onto financial systems and schedules
• Attends monthly project review (MPRs) meetings to ensure understanding/concurrence of project status, potential issues and the accuracy of the forecast
• 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 I

Director

• Lead development of study protocols, analysis plans, and study reports to answer research questions of priority to RWE
• Lead, design, and manage epidemiological, biomarker and/or data science projects
• Lead, plan, design, and conduct analyses for internal and external decision making (e.g., responses to regulatory authorities, rapid analyses of safety queries)
• Lead the identification of fit-for-purpose data for the timely execution of the RWE strategy
• Constructed cohorts using RWD sources (e.g., claims, EHR) and evaluate key variables, including diagnosis and procedures codes, and plan validation studies as needed
• Contribute to the communication of observational research results and methods, including development of pertinent sections of regulatory documents, reports, publications, white papers
• Support the effective communication of study/analysis results to support internal and external decisions
• Coauthor abstracts and manuscripts for external dissemination of methodologic study results
• Contribute to the development of processes and training aimed at increasing the efficiency, quality, and impact of functional activities
• Technical Expertise o Observational research methods (both Primary and Secondary), deep knowledge of biostatistics and analysis methods, understanding of regulatory processes,
• Ability to design studies independently, (ie ability to translate research questions to create study design)

Director, Epidemiology RWE – Immunology, Oncology

Compliance

• Collaborates as Regulatory Subject Matter Expert with major functional area leads to identify and evaluate fundamental issues pertaining to the Site Activation pathway.
• Participates in strategic development activities including account/ portfolio client meetings.
• Line management responsibilities for staff members.
• Develops and maintains strategic relationships with customers in alignment with their assigned projects.
• Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables.
• Prepares and communicates overall Regulatory strategy and status at client meetings.
• Assumes accountability on the CTRA operations on specific project activities.
• Reviews the project budget against project milestones and budget to ensure project profitability.

Principal Clinical Trial Regulatory Affairs, 4+ years in regulatory submissions

General

• Establishes, maintains and updates training material for site contracts lead team and site contract negotiators.
• Oversees negotiations of clinical study agreements (CTA´s) and drives document finalization
• Advises stakeholders on industry trends, norms, and developments surrounding contract negotiations
• Plans contract execution strategy for assigned studies
• Creates and maintains document status reports

Senior Site Contracts Lead

• Works with Medical Director to develop medical plans
• Engages with outside experts/consultants/advisors
• Performs regular and ad-hoc medical review of data listings
• Authors medical data queries
• Partners with Medical Directors for medical data review meetings
• Manages project scope of work
• Collaborates with study team members

Clinical/Medical Scientist – Oncology – Gynecologic Malignancies

• Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan)
• Performs regular and ad-hoc medical review of data listings and data visualization as needed
• Authors medical data queries and reviews query responses
• Partners with Medical Directors for medical data review meetings and safety review meetings
• Manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met
• Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management
• Attends and present at Trusted Process meetings

Clinical Scientist, Medical Monitoring – Oncology – Breast

• Develop medical plans in collaboration with Medical Director
• Conduct medical reviews of data listings and visualization
• Author and manage medical data queries
• Collaborate with project teams on medical data review
• Attend and present at meetings, including internal and external audits
• Comply with data privacy guidelines and standard operating procedures
• May manage limited number of direct reports

Senior Clinical Scientist – Medical Monitoring, Oncology – Breast

Medical writer

• Develop regulatory documents for submission to regulatory agencies globally
• Manage medical writing projects, including timelines and communication
• Participate in cross-functional meetings to provide input regarding deliverables
• Review other documents associated with assigned projects as appropriate

Senior Principal Regulatory Medical Writer – Oncology Preferred

• Leads the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manages medical writing activities associated with individual studies, defining document strategy and coordinating medical writing activities within and across departments with minimal supervision.
• Leads team document reviews and reviews documents for technical issues.
• Coordinates quality and editorial reviews and ensures source documentation is managed appropriately.
• Serves as expert peer reviewer for internal team, providing review comments to give maximum clarity of meaning, accuracy, and relevance.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.

Principal Medical Writer

• Join our Clinical Surveillance & Training (CST) team as a Clinical Scientist, where you will play a critical role in ensuring endpoint quality, data integrity, and trial success across global clinical programs
• Design and deliver scientifically grounded rater training programs to ensure consistent, high-quality endpoint assessment and reduce variability across sites
• Perform comprehensive eligibility reviews, providing a second level of scientific oversight to confirm appropriate patient selection and minimize protocol deviations and safety risks
• Analyze clinical and endpoint data to identify trends, variability, and potential risks—translating findings into actionable insights that improve study execution
• Partner with sponsors and study teams to review protocols and provide expert guidance on endpoint strategy, scale selection, and study design feasibility
• Collaborate cross-functionally with clinical operations, medical, and sponsor teams to proactively identify risks and deliver solutions that protect study integrity

Clinical Scientist – Clinical Surveillance & Training, Clinical Psychologist/Neuropsychologist

• 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
• For the Clinical Monitoring/Site Management Plan (CMP/SMP): 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
• 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 project 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
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met
• Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets
• May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA)
• Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings
• Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions

• Sets up and maintains excellent R-based computing environment.
• Adds missing features to apps and fixes bugs in existing apps.
• Screens the market for supplied data visualization tools and integrates internal/external apps into our working environment.
• Organizes and performs user trainings and is available for user support on demand.
• Is up to date with the latest technical possibilities available on the global market.
• Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates.
• Conducts training sessions, or otherwise trains new hires and enhance the skills of existing personnel.
• Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work.
• Provides independent review of project work produced by other biostatisticians in the department.
• Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
• Collaborates with sponsor, if required.
• May be responsible as Lead Biostatistician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.
• Implements company objectives, and creates alternative solutions to address business and operational challenges.
• As biostatistics representative on project teams, interfaces with other departmental project team representatives preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others.
• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in the SAP and specifications.
• May lead complex or multiple projects (e.g. submissions, integrated analyses), and attend regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study related activities with biostatistics management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.
• Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met.
• Identifies out of scope tasks and escalates to management.
• Provides statistical programming support as needed.
• May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician.
• May serve as a voting statistician on DSMBs and/or DMCs.
• Provides input and reviews, and subsequently follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).

Principal Biostatistician, Sr Biostatistician – R/Rshiny

Content Writer

• Leads strategy development conveyed in proposal documents, ensuring alignment with Syneos Health style, branding, messaging, and business objectives
• Collaborates with internal stakeholders (e.g., BD, operational, medical, finance, and proposals) to develop concise, creative strategies that effectively articulate customer needs and win themes critical to generating new business awards
• Creates high-quality, customized and compelling proposal documents focused on customer solutions that highlight company differentiation, innovation and operational strategy
• Actively drives the proposal strategy from concept through final delivery
• Actively engages in shaping study-specific strategy by making recommendations for cross-organizational services, tools, and technology that differentiate the organization from the competition
• Challenges stakeholders to think creatively, proposing innovative solutions that align with customer and patient needs
• Researches each assigned project indication, applying learnings to inform discussions, as well as strategy and content development
• Drives actions by clearly communicating project milestones and team member responsibilities, allowing flexibility to adapt as priorities shift while maintaining a balance between acquiring necessary input and customer deadlines
• Builds strong relationships with stakeholders and decision makers to expedite problem solving and promote seamless collaboration
• Approaches projects with enthusiasm, supporting ongoing engagement of team members
• Identifies key content for archiving and proactively fills content gaps, developing new content that enhances Syneos Health competitive position
• Serves as the document owner and writer for high-profile RFPs, RFIs, and proactive outreach projects, synthesizing input from multiple contributors into cohesive, persuasive narratives
• Takes an active role in resolving conflicts and removing barriers to maintain progress toward high-quality deliverables, with support as needed
• Meets deadlines consistently by establishing priorities and target dates for document contributions, review, and approval by key stakeholders including executive leadership
• Performs other duties as assigned

Proposal Writer

• Lead development of study protocols, analysis plans, and study reports to answer research questions of priority to RWE
• Lead, design, and manage epidemiological, biomarker and/or data science projects
• Lead, plan, design, and conduct analyses for internal and external decision making (e.g., responses to regulatory authorities, rapid analyses of safety queries)
• Lead the identification of fit-for-purpose data for the timely execution of the RWE strategy
• Constructed cohorts using RWD sources (e.g., claims, EHR) and evaluate key variables, including diagnosis and procedures codes, and plan validation studies as needed
• Contribute to the communication of observational research results and methods, including development of pertinent sections of regulatory documents, reports, publications, white papers
• Support the effective communication of study/analysis results to support internal and external decisions
• Coauthor abstracts and manuscripts for external dissemination of methodologic study results
• Contribute to the development of processes and training aimed at increasing the efficiency, quality, and impact of functional activities

Clinical Trial Manager

Project Financial Analyst I

Director, Epidemiology RWE – Immunology, Oncology

Principal Clinical Trial Regulatory Affairs, 4+ years in regulatory submissions

Senior Site Contracts Lead

Clinical/Medical Scientist – Oncology – Gynecologic Malignancies

Clinical Scientist, Medical Monitoring – Oncology – Breast

Senior Clinical Scientist – Medical Monitoring, Oncology – Breast

Senior Principal Regulatory Medical Writer – Oncology Preferred

Principal Medical Writer

Clinical Scientist – Clinical Surveillance & Training, Clinical Psychologist/Neuropsychologist

Clinical Trial Manager

Principal Biostatistician, Sr Biostatistician – R/Rshiny

Proposal Writer

Director, Epidemiology RWE – Onco or Immunology