Syneos Health

Clinical Operations

• 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 Clinical Project Manager – Oncology/Hematology, Phase III

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
• 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
• Assesses site processes as per the Clinical Monitoring/Site Management Plan (CMP/SMP)
• 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 study 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
• 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
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.

Clinical Research Associate II

Director

• Oversees the conduct of audits and conducts audits in accordance with QA SOPs and WIs
• Responsible for generating own and reviewing and approving others’ audit reports
• Prepares for and hosts or supports customer audits in accordance with QA SOPs and WIs
• Coordinates responses to customer audits of computer system validation and data integrity, and resolves issues with customers, where applicable
• Plans and provides strategies for assessing readiness of Syneos Health offices for potential Regulatory Inspections and conducts such assessments (e.g. develops a program for and conducts ‘mock inspections’)
• Develops and delivers inspection readiness training to staff
• Prepares for and hosts or supports Regulatory Authority Inspections in accordance with QA SOPs and WIs
• Coordinates the preparation and support activities for inspections by Regulatory Authorities, including compilation of any pre-inspection required information
• Communicates findings from customer audits and Regulatory Authority Inspections of Syneos Health promptly to appropriate Syneos Health personnel and provides support on root cause analysis, corrective and preventive actions
• Provides consultancy on computer system quality and data integrity related matters
• Proposes strategies for improvements to quality and compliance of Operations and services
• May participate in and direct activities related to department staff operations such as interviewing and selection, professional development, performance management, employee counseling and separations
• Works with and advises staff on administrative policies and procedures, technical problems, priorities and methods
• May have line management responsibilities for staff members

Associate Director – Corporate Quality

Architect

• Collaborate with internal and external customers to understand their goals, strategies, and challenges.
• Uncover needs that business partners and end users would not be able to articulate on their own.
• Ensure that technology strategies and solutions are aligned with business objectives and can support future growth.
• Develop and document technology architecture that supports business processes, including creating models, diagrams, and frameworks.
• Design scalable and flexible technology solutions that integrate with existing systems and address business needs.
• Act as a liaison between business units and technology teams, translating business requirements into technical specifications.
• Quickly adapts to changes in business strategy; Helps business partners communicate solution value to key stakeholders.
• Engage with stakeholders at all levels to gather input, provide updates, and ensure alignment on STS initiatives.
• Participate in the development of STS strategies and roadmaps that align with business goals.
• Assess emerging technologies and industry trends to recommend innovations that could benefit the organization.
• Provide architectural guidance and oversight for technology projects, ensuring they adhere to the defined architecture.
• Create and maintain detailed business architectural documentation, including system diagrams, process flows, and technical specifications.
• Report on the status of architecture initiatives, highlighting progress, risks, and areas needing attention.
• Provide guidance and training to technology teams and other stakeholders on architecture-related topics.
• Mentor junior architects and other team members to build architectural expertise within the organization.

Principal Tech Business Architect

Compliance

• Provide quality deliverables at the country level
• Ensure compliance with submission/approval timelines
• Monitor basic project finances
• Review and comply with Standard Operating Procedures and Work Instructions
• Prepare and submit various regulatory documents

CRA SSU, Regulatory Experience

Medical writer

• Mentors less experienced medical writers on projects, as necessary
• Compiles, writes, and edits medical writing deliverables
• Develops or supports a variety of documents, including clinical study protocols, clinical study reports, patient narratives, annual reports, and investigator brochures
• Adheres to established regulatory standards, including ICH-E3 guidelines

Medical Writer II – CSR Narrative

Content Marketing Manager

• Create and promote content including articles, blog posts, webinars, and other multimedia
• Support effective external communications programs
• Manage messaging for external and internal communications deliverables

Communications Specialist – Content

Technical Recruiter

• In conjunction with all of Talent Acquisition, creates a deep and diverse talent pool to service resourcing requirements across multiple business units.
• Collaborates directly with hiring managers to understand business and skill set requirements to build a comprehensive strategic hiring plan by setting the vision, strategy, and goals to ensure current and future resource demands are met.
• As a strategic partner to your hiring managers, provide expertise in market insights, talent landscape, and an understanding of talent needs to establish expectations and build a collaborative approach with your customers to meet demands.
• Ensure customer satisfaction by providing regular updates to hiring managers and setting expectations on the hiring process per requisition or department, or both, as required.
• Utilize appropriate sourcing channels (including applicant tracking system, candidate relationship management system, job boards, advertising, networking, employee referral program) to identify qualified candidates.
• Monitor recruitment sourcing methods and provide recommendations to improve applicant attraction. Suggests innovative solutions to sourcing challenges and competitive intelligence from those efforts.
• Offers creative solutions to sourcing hard to fill requisitions in collaboration with the business.
• Responsible to manage full cycle recruiting process to include but not limited to: complete initial screening interview of potential candidates and reject non-relevant applications, prepare candidate profile for hiring manager following interview screen, submit short listed candidates to hiring managers for review, conducts candidate debrief session after interviews are completed and extends verbal offers of employment to successful candidates.
• Ensures data accuracy within Applicant Tracking System.
• Initiates and maintains open communication with hiring managers and Human Resources (HR) colleagues in meeting recruiting needs.
• May create collateral HR materials for trade shows, professional organization meetings, and career fairs. May attend trade shows, professional organization meetings and career fairs.
• May provide training and coaching activities for Talent Acquisition Specialists.
• Performs other job-related duties as assigned.

Senior Technical Recruiter – Talent Acquisition Specialist

Product Manager

• Define and communicate long-term product vision and strategy across a portfolio of products, platforms, or capabilities aligned with business objectives.
• Partner with executive leadership to shape business strategy through product insights, market intelligence, and customer understanding.
• Ensure alignment of product goals across teams and functions, including engineering, data science, design, commercial, and operations.
• Conduct in-depth market, customer, and competitive analysis to identify opportunities, risks, and emerging trends.
• Oversee the full product lifecycle across multiple products or capabilities, from ideation through growth, optimization, and sunset.
• Act as a senior voice of the customer, ensuring customer needs, regulatory considerations, and usability are reflected in product strategy.
• Define and monitor success metrics and key performance indicators (KPIs) at the product and portfolio level to drive outcomes-based decision-making.
• Identify strategic, operational, and regulatory risks and develop mitigation strategies to ensure successful product delivery and adoption.
• Influence prioritization and investment decisions to maximize customer value and return on investment.
• Lead through influence by coaching and mentoring Product Managers and Senior Product Managers, and by establishing product best practices.
• Drive consistency and scalability across products by defining frameworks, standards, and reusable capabilities.
• Build and maintain strategic partnerships with internal teams, customers, vendors, and external partners that enhance the overall product value proposition.
• Represent the product organization with key customers, partners, and industry forums as a product thought leader, as appropriate.

Principal Product Manager

• 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
• Leads the resolution of comments from the client
• 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, when completing medical writing projects, on time and on budget
• 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, as necessary, to produce writing deliverables
• 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
• Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership
• Completes required administrative tasks within the specified timeframes
• Performs other work-related duties as assigned
• Minimal travel may be required (less than 25%)

Senior Medical Writer – Publication Writing

• Responsible for clinical system or clinical reporting support of clinical business operations.
• Collaborates across departments as required.
• Maintains a working level of query/Excel to support the clinical business.
• Responds to customer support inquiries in a timely manner.
• Develops knowledge based on previous inquiries and information shared by business or system experts.
• Supports analysis of findings and retesting once resolved.
• Run and disseminate routine reports.
• Reviews and responds to requests for ad hoc metrics or reporting requests.
• Develop dashboard or customized queries in support of specific reporting requests.
• Deliver prompt and efficient user support, investigating and resolving reported data discrepancies and issues.
• Develop and maintain training materials to ensure user understanding and proficiency.

Clinical Development Operations Analyst

• 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
• Leads the resolution of comments from the client
• 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, when completing medical writing projects, on time and on budget
• 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, as necessary, to produce writing deliverables
• 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
• Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership
• Completes required administrative tasks within the specified timeframes
• Performs other work-related duties as assigned

Senior Medical Writer

Marketing

• Assists in the implementation of master brand marketing and advertising campaigns
• Leads requests from internal stakeholders
• Prepares marketing reports and collects data
• Supports marketing team by obtaining market trends
• Collaborates with digital marketing team to build integrated account journeys

Marketing Coordinator

Human Resources

• Provides global support for all HRIS applications.
• Initiates, leads, and implements HRIS projects of medium to large scope and impact to assigned HR function(s). Collaborates with other departments to proactively identify needs for enhancements/modifications, document business requirements, and creates project plans for the implementation of enhancements and solutions. Supports modifications and serves as a change agent to assist in promoting new designs.
• Identifies areas for improvement in both the processes and systems; continuously researches new system functionality/trends and HR best practices.
• Develops, documents, and implements global procedures that provide consistent processes; creates user guides and checklists for functional practitioners.
• Participates in the testing and implementation of all system upgrades and rollouts of new features; coordinates all user testing and parallel run activities.
• Trains practitioners, managers, and employees on HRIS functionality.
• Participates in project management activities, including work planning and issue tracking.
• Monitors interactions/interfaces with both internal and outsourced systems; addresses error logs.
• Provides technical support for interface integrations between HRIS applications and various third- party applications. Provides hands-on functional, reporting, and technical expertise to users; Serves as help desk for HRIS requests.
• Raises Service Requests via vendor support organizations to obtain solutions to application problems.
• Manages HR data requests; Assembles, analyzes, and formats data into useable reports.
• Develops data integrity protocols for all HRIS applications; Audits HR data to ensure compliance and data integrity; Detects, troubleshoots, and resolves data issues; Supports efforts to maintain accurate master data.
• Defines and enforces standard HRIS functionality to be delivered across the organization; Manages change control for deviations; Advises business functions on design and utilization ofexisting applications.
• Assists with other HR projects, both within HRIS and in the various HR functional areas.
• Serves as partner to all HR functional areas and liaises with other business functions.

Senior HRIS Analyst – Workday Core, Advanced Compensation

• Provides global support for all HRIS applications.
• Initiates, leads, and implements HRIS projects of medium to large scope and impact to assigned HR function(s). Collaborates with other departments to proactively identify needs for enhancements/modifications, document business requirements, and creates project plans for the implementation of enhancements and solutions.
• Supports modifications and serves as a change agent to assist in promoting new designs.
• Identifies areas for improvement in both the processes and systems; continuously researches new system functionality/trends and HR best practices.
• Develops, documents, and implements global procedures that provide consistent processes; creates user guides and checklists for functional practitioners.
• Participates in the testing and implementation of all system upgrades and rollouts of new features; coordinates all user testing and parallel run activities.
• Trains practitioners, managers, and employees on HRIS functionality.
• Participates in project management activities, including work planning and issue tracking.
• Monitors interactions/interfaces with both internal and outsourced systems; addresses error logs.
• Provides technical support for interface integrations between HRIS applications and various third-party applications. Provides hands-on functional, reporting, and technical expertise to users; Serves as help desk for HRIS requests.
• Manages HR data requests; Assembles, analyzes, and formats data into useable reports.