Syneos Health

Project Manager

• Manages a project as Project Manager overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and regulatory requirements
• Acts as primary liaison 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 clinical team to ensure quality, timelines and budget management
• Accountable for the financial performance of assigned projects
• Accountable for all project deliverables for assigned projects and/or project regions
• Coordinates activities and deliverables of all project conduct partners and proactively identifies and manages issues
• Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools
• Responsible for project management components of inspection readiness for all aspects of the project conduct, including Trial Master Files
• Prepares project management reports for clients and management

Senior Clinical Project Manager, Associate Director – Global Role, Multisponsor

Operations

• Participates in both short and long-term planning for all aspects of the Company’s operations and growth.
• Contributes operational input to other departments as appropriate, including developing and distributing appropriate reports to executive management.
• Manages the forecasting, planning and logistics for clinical operations activities, including the direction and scheduling of clinical operations resource allocations, ensuring performance and quality standards are met.
• Reviews performance of the Company’s activities and makes recommendations for improvement in quality/efficiency.
• Periodically, conducts site evaluations annually.
• Reviews and provides input on study proposals, while participating in the sales and marketing function as it relates to the Company’s clinical operations activities.
• Participates as a primary source of operations information in the budgeting process for clinical studies and the department.
• Liaison and facilitator between the Company’s operation’s departments and clinical business units for project related tasks and/or issues.
• Plans and negotiates resources with line management of functional areas.
• Serves as a Project Advisor on project teams by providing input regarding the operational and project management aspects of the projects.
• May develop and refine project management processes within the Company, using established process modeling techniques.
• Leads teams of subject matter experts to develop and review SOPs and WIs related to any area concerning project management to support new or existing project management processes.
• May work with the Project Manager on the study start up and financial management tasks of a project to ensure success of the overall project.
• Implements enterprise wide project management systems and tools.
• Evaluates project progress, while producing and distributing resource status reports as well as functional area plans, to appropriate members of executive and senior management.
• Ensures thorough clinical study feasibility and appropriate distribution of studies to consortium sites.
• Develops, collects, and analyzes project metrics, while holding project reviews with operational staff focusing on budget, schedule and risk analysis.
• Responsible for the development of clinical research capabilities within the Company’s member sites as performed through leadership and management of field operations activities as required.
• Implements global project management systems and processes to increase efficiency.
• Plans for the efficient allocation of resources within operations.
• Ensures compliance with Good Clinical Practices sponsor contracts as well as all Food and Drug Administration and International Conference on Harmonization requirements.
• Oversees satisfactory conduct of all clinical research studies.
• Develops and implements policies, procedures and standard operating procedures (SOPs) for clinical operations activities, as well as applicable training programs for staff and network sites.
• Interacts with senior management of pharmaceutical and biotechnology sponsors on operational issues.
• Within the department, approves courses of action on all management / human resources’ matters, including salary administration; employment hires, transfers, terminations; performance appraisals and professional development; job description preparation, and employee counseling.
• Works with and advises staff on administrative policies and procedures, technical problems, priorities and methods.
• Performs other work-related duties as assigned.
• Moderate travel may be required (up to 50%).
• Represents the Company at professional meetings or seminars.

Executive Director, Business Operations Management

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

Security Engineer

• serve as the senior security advisor to the assigned business-aligned STS leadership team
• partner across all departments and teams globally within the assigned business unit
• align security priorities with STS business strategy, digital roadmaps, and regulatory requirements
• embed security-by-design principles into portfolio planning, demand intake and product development processes
• represent security requirements in portfolio governance forums
• provide senior level accountability for the business unit security strategy
• ensure timely mitigation or closure of risks
• drive business engagement in continuity and disaster recovery planning

Business Information Security Leader – Corporate Systems

• Serve as the senior security advisor to the assigned business-aligned STS leadership team.
• Partner across all departments and teams globally within the assigned business unit.
• Align security priorities with STS business strategy, digital roadmaps, and regulatory requirements.
• Embed security-by-design principles into portfolio planning, demand intake and product development processes.
• Inform Information Security priorities with STS product team strategy & goals.
• Represent security requirements in portfolio governance forums.
• Provide senior level accountability for the business unit security strategy, ensuring consistent direction, prioritization, and alignment with company wide objectives while maintaining strong partnership with the CISO.
• Maintain visibility into the aggregated cyber risk posture of the assigned business unit.
• Ensure risk assessments are conducted, partnering with the Risk Management function, for new and materially changed technologies.
• Serve as a security risk advisor to business-aligned STS leadership, provide mitigation and remediation guidance, track and highlight risk treatment plans progress.
• Provide formal risk posture reporting to STS leadership on a defined cadence.
• Escalate roadblocks inhibiting timely mitigation or closure of risks.
• Prevent unmanaged technology risk proliferation.
• Exercise senior decision authority for cybersecurity and technology risk matters within the Business Unit, including oversight of risk acceptance, escalation to enterprise forums, and long-term risk posture considerations.

Business Information Security Leader – Commercial

Compliance

• Collaborate with internal teams to ensure regulatory compliance for clinical trials
• Prepare and submit regulatory documents to health authorities
• Liaise with regulatory agencies and manage relationships
• Monitor changes in regulations and update policies as needed
• Provide training and guidance on regulatory matters

Principal Clinical Trial Regulatory Affairs – CTRA

Affiliate Manager

• The Site Care Partner is the main point of contact for investigative sites to develop and maintain site relationships and to drive efficient operational delivery with high quality
• Supports processes to optimize country & site selection activities and leads site start-up activities through activation
• 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.
• Leads site management from start up, conduct, and closeout including site recruitment planning and delivery
• Acts as operational point of contact for site-level questions, liaising with and escalating to appropriate team members
• Acts as a local/country Subject Matter Expert for regulations and operational implementation
• Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
• Must be able to quickly adapt to changing priorities to achieve goals / targets.
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
• Participates in and may lead 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.

Site Care Partner, Senior CRA - Sponsor Dedicated

• Lead design, develop, and maintain Oracle APEX application to meet business requirements.
• Collaborate with business analysts and stakeholders to understand application requirements and translate them into efficient database designs.
• Integrate Oracle APEX applications with other systems and databases as needed.
• Write complex SQL queries, stored procedures, functions, triggers, and packages to implement business logic.
• Optimize database performance by analyzing query execution plans, indexing strategies, and tuning SQL statements.
• Provide technical guidance and mentorship to junior developers on Oracle APEX development best practices.
• Participate in code reviews and contribute to the continuous improvement of development practices.
• Implement Rest web services to fetch and push data.
• Develop and maintain technical documentation including data models, schema diagrams, and standard operating procedures.
• Stay up to date with the latest Oracle technologies and best practices.
• Review and validate solution design and ensure it covers all the technical aspects.
• Coordinate with the offshore teams on the development activities and participate in solution design discussions.
• Perform other work-related duties as assigned.
• Participate as a member of a high-performance team for targeted / strategic initiatives.