Syneos Health

Clinical Research

• Support Safety Analytics with ADaM /TFL standard development for Hypersensitivity and Injection/Infusion Site Reaction deliverables
• Support Safety Analytics and the study team on the delivery of Hepatic Patient Profile display
• Provide ADaM /TFL/interactive package review support for the Safety Analytics team supported portfolio deliveries, including cross-checks between interactive outputs and TFLs
• Interrogating root cause of issues identified during ADaM /TFL/Interactive package review

Senior Safety Biostatistician – North America

Software Engineer

• Use SAS or other software to develop custom programming code
• Generate summary tables, data listings, graphs and derived datasets
• Ensure outputs meet quality standards and project requirements
• Perform validation programming
• Manage scheduling and time constraints across multiple projects
• Conduct effective internal meetings and distribute relevant information

Senior Statistical Programmer

Director

• Leadership and local strategic planning and operational delivery of assigned clinical trials
• Accountable for oversight of all assigned studies within the country
• Planning and executing assigned country study goals and commitments
• Develop and maintain optimal relationships with key institutions within the country
• Drive the identification and inclusion of sites for diverse recruitment
• Oversees regional study feasibility, site monitoring performance, quality metrics and all relevant activities
• Collaborates cross-functionally to build and maintain strong relationships
• Communicates regularly on country study status and escalates unresolved issues
• Collaborates to develop and execute local implementation of risk management plans
• Works with the Study Start-Up Team to ensure timely submissions and appropriate approvals
• Maintains oversight and ensures consistency across studies and alignment across CROs

Associate Director, Clinical Trial Management

Medical writer

• Leads the clear and accurate completion of medical writing deliverables.
• Manages medical writing activities associated with individual studies.
• Completes a variety of documents including clinical study protocols and reports.
• Adheres to established regulatory standards and guidelines for medical writing projects.
• Coordinates quality and editorial reviews and ensures source documentation is managed appropriately.
• Acts as a peer reviewer for internal team documents for clarity and format.
• Reviews statistical analysis plans for appropriateness and provides feedback.
• Interacts and builds relationships with clients and peers in various fields.
• Mentors and leads less experienced medical writers on complex projects.

Senior Medical Writer – Regulatory

Business Analyst

• Develop, maintain, and optimize the organization’s knowledge management strategy
• Oversee the creation, governance, and continuous improvement of knowledge assets
• Ensure operational preparedness for new or changed IT services
• Act as the bridge between project delivery and operational teams

Service Management Analyst II

• act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape
• collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals

Medical Writer – Publications

Human Resources

• Responsible for the full range of HRIS project life cycle including discovery, design, development, testing and support.
• Functioning as the Subject Matter Expert for the Company’s HRIS and HRSD systems, this position is expected to drive innovation to enhance the user experience, support HR process and technology efforts, and deliver value to our employee base.
• 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 of existing 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 – Reporting

Operations

• Under the leadership of the Director of Development Operations Quality (DOQ) or designee, this position is responsible for DOQ collaborations with Global Monitoring and Clinical Study Support and Regional Clinical Operations
• This position leads collaborations at country and regional level, as assigned
• This position leads consultation on continuous improvement of established processes and procedures
• This position provides global strategic and tactical leadership within our study teams to achieve overall quality goals while always maintaining inspection readiness
• This position may sit across the entire global portfolio or a particular asset(s)
• These activities will be in collaboration with Quality Assurance (QA) and the Quality Lead/Specialist, as needed
• With QA leading, this position supports study teams during regulatory inspections
• Develop and maintain guidance and process to facilitate DOQ support of Study Teams
• Develop, contribute, and support facilitation, presentation, and communication of GCP Lessons Learned, GCP Cases, or other trending analysis
• Provide training or awareness for new or established processes or guidance provided by DOQ
• Collaborate in developing and presenting DOQ content for distribution within the organization
• Author relevant content for the DOQ SharePoint site
• Act as lead on specified DOQ workstreams or assigned DOQ initiatives
• In collaboration with the Operations Quality Lead/Specialist, provide consultation and support for ad hoc requests that are sent to DOQ
• Consult, develop, or identify opportunities for continuous improvement projects
• Develop, review, and analyze KQI or metrics that may identify emergent issues or trends or demonstrate strong adherence to quality within Development Operations
• Stay current with knowledge of clinical trial requirements, ICH GCP guidelines, and global regulatory requirements for the management of clinical trials
• Facilitate and support cross-functional stakeholder engagement to ensure adequate representation for consultation towards consensus
• Develop matrix relationships to involve process experts and conduct improvement activities
• Collaborate with DOQ Leadership to ensure integration, alignment, and consistent messaging across the organization
• Promote a culture of quality, continuous improvement, and operational excellence that engages colleagues in positive dialogue consulting and supporting in all we do

Global Operations Quality Manager

Clinical Operations

• Lead Biomarker Study Operations
• Oversee biomarker and bioanalytical activities across Sponsor and Collaborative programs
• Serve as the operational point of contact for all biomarker-related processes
• Work closely with clinical study teams (Phases 1–4) to integrate biomarker strategies into broader clinical development plans
• Plan and manage the collection, tracking, and analysis of biological specimens
• Advise study teams on best practices for sample management and logistics
• Drive Clinical Project Delivery
• Lead cross-functional teams through the full clinical trial lifecycle, from start-up to closeout
• Ensure studies stay on track with respect to timelines, budget, scope, and quality
• Act as the main liaison between the sponsor and study partners
• Monitor and manage project financials, ensuring fiscal responsibility
• Proactively identify and resolve operational issues and risks
• Ensure Operational Excellence
• Maintain high-quality documentation, including Trial Master File (TMF) accuracy and completeness
• Keep study systems and databases current and audit-ready
• Prepare project reports and updates for sponsors and internal stakeholders
• Plan and facilitate internal and external meetings
• Support inspection readiness and regulatory compliance throughout the project

Clinical Project Manager II – Biomarker Study Management

• Serves as a statistical department resource, mentors biostatisticians on job skills, oversees or develop training plans or materials for Biostatistics associates.
• Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
• Responsible for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
• Reviews SAS annotated case report forms (CRFs), SAS 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.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• 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 statisticians in the department.

Principal Biostatistician – RWE, PhD Required

Compliance

• Responsible for day-to-day contribution to project teams and projects.
• Acts as a representative of the GRAS regulatory department with other departments.
• Contributes technical expertise to proposals and assists with Business Development initiatives.
• Understands project budgets, scope of projects, allocated hours, and tracks compliance.
• Interacts with internal and external personnel, clients, and technical experts on projects.
• Conducts regulatory research on projects as needed.
• Provides operational advice to clients.
• Prepares consulting reports under guidance.
• Arranges, leads, and reports on client meetings.
• Contributes to regulatory agency meetings.
• Writes IND and product registration dossiers, clinical reports, and other regulatory documents for submissions.
• Prepares full regulatory submissions for INDs, product registrations, and post approval maintenance activities, and participates on project teams.
• Acts as a resource for technical knowledge.
• Participates in quality improvement efforts to increase overall operational efficiency.
• Contributes to the building of the regulatory systems and infrastructure needed for GRAS.
• Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars and association meetings, authoring articles for trade journals, and participating in industry association through memberships and on committees.
• Provides internal training in appropriate areas of expertise to other Departments.
• May act as a Line Manager to a small team, dependent on the location.

Senior Regulatory Consultant, CMC – API, EU Market

• The Managing Director is a senior individual contributor responsible for driving profitable growth, customer satisfaction and high-quality operational delivery for the company.
• This position oversees and is accountable for the financial performance of one or more assigned accounts as well as front of shop clinical delivery within defined geography;
• develops and executes strategies and operational tactics to grow the account(s), geography or achieve material growth and market share in the geography through new opportunities.
• Acts as the main executive-level customer relationship holder and contact for major decisions affecting the relationship, growth, delivery, and financial health of each account and / or develops, deploys, and executes with key Syneos Health Stakeholders overall strategy for the geography achieving agreed metrics, targets and goals.
• Leverages, develops, and nurtures executive-level relationships with the key customers and decision-makers, identifying, developing, and driving opportunities for growth and value creation.
• Work with project teams to coordinate clinical trials and other assigned services;
• provides direction and strategy for the development of local business entities Interacts and collaborates with Global Business Units, Human Resources, Finance and Legal departments for functioning of country office as required.
• Represents the country in global projects to global customers providing support in education, feasibility and delivery oversight where needed Identify and execute growth opportunities for a geography including inorganic strategies.
• Approves courses of action on salary administration, interviewing and selection, terminations, professional development, performance appraisals, position description preparation, and employee counseling.

Managing Director

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 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.
• For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I. Additional responsibilities include: Site support throughout the study lifecycle from site identification through close-out
• Knowledge of local requirements for real world late phase study designs
• Chart Abstraction activities and data collection
• Collaboration with Sponsor affiliates, medical science liaisons and local country staff

Clinical Research Associate II – Sponsor Dedicated

• provide supporting services to the Clinical Trial Manager/operational team in execution of the trial(s)
• maintain effective communication with the project team through oral and written correspondence and status reports to ensure alignment with study timelines
• reviewing, developing, and writing clinical trial documents and manuals, including study manuals, laboratory or biomarker plans, and other supporting documents
• creation of the master ICF template and review/approve site changes (in consultation with legal, safety when warranted)
• update template for new risks and new amendments information
• feasibility and evaluation of investigative sites
• working closely with the Clinical Trial Logistics group as well as coordinating and monitoring activities at investigational sites
• review monitoring trip reports and supporting the monitoring organization
• develop relationships with investigational sites and institutions to enhance conduct of the trial
• oversee 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.

Clinical Operation Lead – Clinical Trial Manager

• Serve as senior point of contact for assigned clients, fostering strong, lasting partnerships
• Identify and implement tailored solutions aligned to client needs and strategic priorities
• Represent the organization in governance meetings and lead proposal development and bid defense strategies
• Own strategy and execution across complex clinical research projects
• Conduct regular reviews (risk, financial, and delivery) to maintain project health
• Ensure budget accuracy, profitability, and appropriate scope management
• Cultivate a collaborative, high-performance culture across cross-functional teams
• Mentor project leaders, empowering independent problem-solving and continuous growth
• Lead data-driven reviews to mitigate risks and resolve quality concerns
• Drive corporate and departmental initiatives focused on efficiency and innovation