Syneos Health

Risk

• Serve as a recognized RBQM and Centralized Monitoring subject matter expert across global clinical programs
• Influence study quality strategy from protocol review through study execution
• Partner directly with sponsors and senior stakeholders to develop and execute monitoring approaches
• Shape risk-based monitoring strategies that impact study quality, efficiency, resource utilization, and patient safety
• Operate in a highly consultative role with significant visibility and organizational influence
• Leverage advanced analytics and centralized monitoring methodologies to drive proactive risk identification and mitigation
• Collaborate with experienced cross-functional clinical research professionals
• Work at the forefront of evolving RBQM methodologies, technology platforms, data analytics, and emerging innovations within clinical research
• Opportunity to mentor colleagues and help drive continuous improvement across programs and teams

Central Risk Manager – RBQM, Central Monitoring

Manager

• Provides a key role in helping enterprise projects and strategic initiatives meet business, schedule, and budget objectives.
• This role focuses on the people side of change, including changes to business processes, systems and technology, job roles, and organizational structures internally, as well as externally with clients as part of a service offering.
• Works with business leaders and project teams to create and implement change management strategies and plans that minimize resistance and maximize engagement, adoption, and proficiency.
• Develops change management strategies and work plans for multiple internal/ external projects based on a situational awareness of the change and the groups impacted by the change.
• Collaborates with the project teams on the Change Management discipline and work plans for project initiatives, as well as, development of the framework for related processes and procedures to implement change management strategies and the seamless implementation of various related tactics (readiness assessments, focus groups, change agents program, targeted communications), to ensure a sound methodology and platform for delivery of plans/services.
• Ensures a sound communications strategy, plan, and timeline, including identifying the most effective communication channels and ensuring all messaging aligns with company standards and guidelines. Writing and delivery of communications may be performed independently or in partnership with Content and Corporate Communications teams.
• Applies structured change management methodologies and approaches to support successful adoption and sustainment of organizational changes.
• Identifies potential risks and anticipated points of resistance, and works with business stakeholders to develop specific plans to mitigate or address the concerns.
• Develops actionable and targeted change management plans, including communication plans, sponsor roadmaps, leadership coaching plans, operational readiness activities, and other change interventions as needed.
• Partners with cross-functional stakeholders across business, operational, and client-facing teams to support strategic transformation initiatives and enterprise priorities.
• Supports initiatives within clinical and life sciences environments, demonstrating understanding of the operational, regulatory, and organizational complexities within the industry.
• Drives initiatives from concept through implementation, ensuring alignment across impacted teams, stakeholders, and leadership groups.
• Translates complex organizational changes into clear, digestible, and actionable messaging tailored to diverse stakeholder audiences.
• Demonstrates strong stakeholder awareness and emotional intelligence, proactively identifying underlying concerns, priorities, and engagement needs across teams and leaders.

Manager, Change Management

Medical writer

• Develop regulatory documents for submission to regulatory agencies globally
• Manage medical writing projects, including developing timelines
• Participate in cross-functional meetings to provide input regarding medical writing deliverables
• Review other documents associated with the assigned project(s)

Senior Principal Medical Writer – Regulatory Submission Docs, Oncology Preferred

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.

Senior Oracle APEX Developer

Medical Reviewer

• Ensure data readiness for important milestones including, but not limited to, interim analysis, final analysis, snapshots to support submissions, Data Monitoring Committee reviews and publications
• Review participant level data across a study in adherence with CRF Completion guidelines (CCGs) and the Data Review Plan (DRP)
• Conduct point-to-point data checks (e.g. verifying the presence of a lab test that satisfies study inclusion criteria) and interpretive analysis (e.g. reviewing to identify inconsistencies in the participant’s data).
• Generate queries on discrepant data and follow to resolution including escalation of issues that cannot be resolved through the query process
• Create and use data review best practices and associated data review tools to identify trends and any safety signals
• May identify protocol deviations during routine clinical review and escalation as appropriate
• Follow relevant SOPs and regulations, have an excellent understanding of and comply with applicable training requirements, constantly seeking further improvements in quality and efficiency of clinical procedures
• May liaise with data management, clinical and site management along with other members of the study team Attend Clinical Meetings and Study Meetings, as necessary

Clinical Data Reviewer, Internal Medicine

• Develop and maintain statistical programming standards and best practices
• Provide technical expertise and leadership in the development of statistical programs
• Collaborate with statisticians and other stakeholders to understand and address their programming needs
• 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 – ADAM, TLF

Director

• Provide overall strategy and direction of clinical trials
• Serve as senior operational leader and strategic advisor for top-tier clients
• Define and oversee the strategic direction for delivery of research projects
• Maintain accountability for financial health of portfolio
• Inspire and lead a culture of innovation and collaboration across the organization

Senior Director/Director, Strategy – Delivery, Neurodegenerative

• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Acts as lead for assigned writing projects.
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
• Develops or supports a variety of documents that include, but not limited to: Clinical journal manuscripts, clinical journal abstracts, posters, and oral presentations.
• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
• Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
• Serves as peer reviewer on internal review team providing review comments on draft and final documents.
• Adheres to established regulatory standards, including but not limited to Journal/congress specific guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.
• Performs on-line clinical literature searches, as applicable.
• Familiarity with figure-creation and data visualization software, including tools such as GraphPad Prism and Adobe Illustrator, for developing high-quality scientific figures and graphics.
• Familiarity with publication planning software e.g. Datavision and PubConnect (VeevaVault Promomats)
• Reviews deliverables for scientific accuracy, data and referencing quality, appropriate style, and correct branding of scientific/medical assets.
• Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
• Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
• Completes required administrated tasks within the specified timeframes.
• Performs other work-related duties as assigned.
• Minimal travel may be required (less than 25%).