Syneos Health

Operations

• Provide strategic and operational leadership for the global Project Management function, ensuring consistent, high-quality delivery across regions and therapeutic areas
• Establish and maintain global standards, frameworks, and best practices for project planning, execution, risk management, and reporting
• Drive a culture of accountability, proactive risk management, and continuous improvement within the project delivery organization
• Provide leadership and governance for Clinical Supply Trial Management, ensuring alignment with study requirements, timelines, and regulatory standards
• Oversee the Central Services Team responsible for supporting bids, budgeting, and proposal data management
• Provide global oversight and accountability for TMF strategy, governance, and operational performance
• Partner with Finance and senior leadership to ensure strong financial management across the portfolio
• Serve as a senior escalation point for complex delivery, operational, or client issues
• Lead, develop, and inspire a global, multi-layered leadership team across PM, Clinical Supply Trial Management, Central Services, and TMF

Global Head of Project Delivery Operations

Director

• Serve as the executive relationship holder for assigned accounts, influencing at the C-suite and senior leadership levels.
• Operate as an extension of the executive team.
• Develop and execute multi-year account strategies that integrate the Account Protector, Builder, and Fixer playbooks based on account maturity and business context.
• Partner with internal stakeholders across delivery, operations, finance, and commercial to ensure alignment with customer objectives and consistent delivery of results.
• Identify, prioritize, and pursue new business opportunities through proactive engagement and tailored proposals.
• Lead and orchestrate cross-functional account teams to deliver high-impact results, ensuring accountability for financial performance, quality metrics, and customer satisfaction.
• Apply a deep understanding of the customer’s ecosystem, decision-making dynamics, and business objectives to anticipate risks, identify inflection points, and create innovative, data-driven solutions that advance mutual success.
• Maintain a comprehensive view of the customer’s business landscape and proactively influence opportunities for growth.

Managing Director

Clinical Research

• Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
• Collaborates with the sponsor, if required.
• May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report.
• Coordinates the activities of other biostatistics and statistical programming 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.
• 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.
• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications.
• Implements company objectives, and creates alternative solutions to address business and operational challenges.
• Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives.
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from 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 and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician.
• May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
• Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness.
• Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.
• Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
• Coaches and mentors other Biostatistics staff.
• Performs other work-related duties as assigned.
• Minimal travel may be required.

Principal Biostatistician, Medical Affairs

Manager

• 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 in relation to daily activities of their team members
• Develops and executes mitigation and remediation plans for non-compliance as needed
• Holds responsibility for headcount management in relation to their team
• Proactively communicates and manages customer issues through assigned escalation channels
• Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs)
• Conducts oversight visits as required for Clinical Research Associates
• Responsible for knowledge sharing across their own team to disseminate best practices
• Makes informed and data-driven decisions that positively impact their team’s performance
• Responsible for active management of team members’ performance through the established Syneos Health process

Manager FSP360

Project Manager

• Drive the operational and financial success of Phase III clinical trials.
• Lead cross-functional teams across Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Medical Affairs, Pharmacovigilance, and QA.
• Act as the primary liaison with clients, ensuring smooth project launch, conduct, and closeout.
• Oversee project deliverables, timelines, and budgets while proactively identifying and mitigating risks.
• Mentor junior project managers and project support staff, fostering collaboration and professional growth.
• Own project budgets, forecasts, and financial performance.
• Ensure alignment and accountability across all vendors and study partners.
• Implement contingency plans and risk mitigation strategies to keep projects on track.
• Maintain and evaluate project progress using advanced tracking tools.
• Prepare and present project materials for internal and external stakeholders.
• Support inspection readiness and Trial Master File compliance.
• Participate in bid defense meetings as the potential project lead.
• Build strong client relationships to generate new opportunities.
• Stay up-to-date on oncology/hematology trends and the evolving drug development landscape.
• Train and mentor new project managers and clinical staff.
• Facilitate team communication, collaboration, and professional development.

Senior Project Manager – Oncology/Hematology

Data Scientist

• Acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups
• Coordinate the work of the assigned Data Management/Data Operations team
• Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
• Provides project specific training to internal and external audiences as required
• Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed
• Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management
• Plan, manages and requests resources for assigned projects
• Develop and maintain project plans, specifications and documentation in line with SOP requirements
• Maintains documentation on an ongoing basis and ensures that all TMF filing is complete and up to date
• Participates in, and presents at internal, Sponsor, third-party, and investigator meetings
• Plans for and creates necessary documentation to support internal and external audits; participates in such audits
• Trains and mentors data management staff
• Prepares input for, and participates in proposal bid defense meetings
• Maintains proficiency in Data Management systems and processes through regular training
• Performs other work related duties as assigned

Project Data Manager

• Serve as a strategic leader embedded within a sponsor’s clinical development organization
• Integrate the patient voice across the full development lifecycle—from early molecule strategy through clinical execution and evidence generation
• Influence how trials are designed and how development decisions are made at an enterprise level
• Lead global strategy for patient‑focused trial design and patient experience enhancement
• Collaborate with Clinical Operations, Clinical Research, Regulatory, Data Science, Medical Affairs, Public Affairs, Commercial, and Corporate Affairs

Patient Engagement Associate Director – Design and Innovation

• 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.
• 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).
• Participates and presents in key meetings such as Kick Off Meeting.
• Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs.

Clinical Trial Manager – Sponsor Dedicated

• Manage a high volume of global ISR and collaborative studies, ensuring compliance, scientific integrity, and timely progression
• Serve as the primary operational contact for principal investigators and study teams, providing ongoing support from start-up through completion
• Ensure accurate tracking of study status, milestones, documentation, and deliverables across the ISR/CO portfolio
• Partner with Medical Affairs to facilitate study progress, troubleshoot issues, and remove barriers to execution
• Oversee study budgets, financial tracking, and forecasting for assigned ISR/CO programs
• Build strong working relationships with Medical Affairs, sponsors, and investigators to ensure alignment and clarity of expectations
• Participate in protocol-specific onboarding and study-related training

Project Manager II – Late Phase Oncology, ISR/CO Study Manager

• Become the Operational Powerhouse Behind High‑Impact Clinical Initiatives
• Drive Clear, Impactful Communication: Draft crisp, compelling internal communications, updates, and announcements
• Build and refine templates, newsletters, intranet content, and collaboration posts
• Maintain SharePoint and internal communication sites to ensure the organization stays aligned
• Coordinate non‑portfolio projects—tracking timelines, deliverables, and action items
• Support resource alignment and data tracking across tools like Smartsheet and internal systems
• Manage reports, dashboards, shared repositories, and operational documentation
• Prepare agendas, take high‑quality minutes, and keep stakeholders accountable
• Support large‑scale events, all‑hands meetings, and virtual sessions
• Handle systems requests, follow-ups, and day‑to‑day operational needs
• Problem-solve across teams to remove roadblocks and keep workflows moving

Project Manager I – Clinical Business Strategy, Operations

Medical writer

• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision
• Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings
• Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides
• Coordinates quality and editorial reviews
• Ensures source documentation is managed appropriately
• Leads team document reviews, and reviews documents as needed
• Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency
• Provides feedback to further define statistical output required and document needs
• Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs
• Performs online clinical literature searches and complies with copyright requirements
• Identifies and proposes solutions to resolve issues, escalating as appropriate
• Provides technical support, training, and consultation to department and other company staff
• May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities
• Mentors and leads less experienced medical writers on complex projects, as necessary
• Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing.

Principal Medical Writer – Publications

• Develop, negotiate, and manage US site budgets and clinical trial agreements
• Collaborate closely with internal teams, external stakeholders, and major academic institutions
• Build US site budget templates and study-specific budget language for Pharma & Vaccine clinical trials
• Lead direct negotiations with large academic institutions and other critical stakeholders
• Proactively escalate risks, timeline impacts, or delays that could affect CTA execution
• Maintain accurate and timely updates in departmental trackers and databases
• Support and train additional team members

Senior Site Contracts Manager – Sponsor Dedicated

Software Engineer

• Uses SAS or other software to develop custom programming code to generate summary tables
• Ensures outputs meet quality standards and project requirements
• Performs validation programming and collaborates with project team members
• Maintains organized project documentation and ensures quality control
• Develops specifications for datasets according to statistical requirements
• Participates in sponsor meetings as statistical programming representative

Senior Statistical Programmer

Clinical Operations

• Manages a project as a Project Manager overseeing interdisciplinary clinical research studies and/or programs and ensures compliance with GCP, relevant SOP’s and regulatory requirements
• Acts as primary liaison and/or facilitator 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 project team to ensure quality, timelines and budget management
• Implements resource strategies to achieve project goals
• Accountable for all project deliverables for assigned projects
• Develops contingency planning and risk mitigation strategies to ensure successful delivery of study goals
• Identifies and implements performance improvement and operational efficiencies
• Maintains and evaluates project progress by maintaining timelines, project plans and other tracking/analysis tools
• Produces and distributes status, resourcing, and tracking reports as well as functional area plan to customers, appropriate team members and senior management
• Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports
• Attends and presents information at internal and external project meetings
• Develops strong relationships with current and prospective clients to generate new and/or add-on business for the future
• Supports the Business Development Department by providing information on Company's capabilities, patient populations, etc. and presents Company capabilities as well as project management specific responsibilities at Customer proposal defense meetings
• Works with Business Development and the Proposal/Contracts groups to develop proposals for Customer requested opportunities
• Responsible for quality and completeness of TMF for assigned projects
• Accountable for the financial performance of each project assignment
• 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

Senior Clinical Project Manager, RWE

• 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.
• May participate in bid defense meetings where presented as potential project manager.
• May be required to line manage other project management team members and clinical monitoring staff.