Syneos Health

Clinical Operations

• Line management of Clinical Operations staff
• Manage staff by establishing goals that will increase knowledge and skill levels
• Review workload for all staff in reporting chain
• Provide expert operational oversight and guidance to support prioritization of activities
• Assist in recruiting new staff
• Ensure quality and adherence to Standard Operating Procedures
• Work closely within appropriate business unit/region to ensure staff performance on studies
• Develop and oversee training plans to address performance deficiencies
• Organize and chair clinical staff meetings at regular intervals
• Facilitate and support project and team/country reviews

Manager, Clinical Operations – CRA Line Management, CRA Monitoring Experience Required

Clinical Research

• Conduct data integrity reviews to ensure accuracy and traceability of data used in analyses
• Verify statistical output by conducting various analyses and visualizations to confirm accuracy
• Provide analysis, modeling, and visualizations of data from scientific studies
• Analyze laboratory data to assess stability of drug substance and drug product
• Create stability graphs suitable for regulatory submission documents
• Compile/format data from one or more data sources
• Conduct testing of automation tools
• Co-author technical reports
• Prepare Statistical Analysis Plans (SAPs)
• Responsible for the statistical aspects of the protocol
• Reviews SAS annotated case report forms and other study documentation
• Creates or reviews programming specifications for datasets, tables, listings, and figures
• Directs the activities of other biostatistics personnel on assigned projects
• Conducts verification and quality control of project deliverables
• Provides statistical programming support as needed
• Prepares for internal meetings and demonstrates respect for opinions of others
• Supports business development activities

Principal Biostatistician, RWE, Commercial DBs

Compliance

• Gather new regulatory information through routine surveillance of agreed regulatory sources
• Reviews surveillance alerts and queries and determines actions to be taken
• Support ad-hoc research requests from the business and gather regulatory information for potentially new topics
• Manage Regulatory Intelligence Network list of functional SMEs
• Interacts with external and internal experts to collect country and region-specific regulatory intelligence
• Conducts searches within commercial Regulatory Intelligence databases to identify regulations and guidelines relevant for clinical regulatory intelligence
• Keeps abreast of regulations, trends, developments, and advances in the global regulatory environment
• Identifies and responds appropriately to issues and problems, providing innovative and effective solutions
• Recommends and implements enhancements of Syneos Health Regulatory Intelligence processes to maintain the Regulatory Intelligence System

Senior Consultant – Regulatory Intelligence

Analyst

• Serves as financial analyst for Business Unit Controller(s) and Associate Director(s) Finance
• Prepares, reconciles, analyzes and reports Business Unit(s) revenue, contracts, projects, and associated metrics
• Produces financial and other business analyses, interpretation, and investigation of data for operations for assigned projects and contracts
• Ensures all reporting activities are accurate and prepared within established timelines
• Supports Business Unit Controller in recording revenue each month for Unit, Fee for Service and Fixed Price contracts
• Loads project budgets into Oracle/Revenue Wizard and maintaining key member lists (project set up) and other project data in Oracle and associated systems and schedules
• Drafts project level actual versus budget/forecast variance analysis monthly as well as monthly reports for distribution in analyzing monthly results
• Drafts monthly forecasting of financial results (backlog)
• Meets established deadlines for Revenue and Backlog submittals
• Timely preparation of project close out reconciliations
• Reviews, with assistance, executed Work Orders and Change Orders for bonus or other anomalies
• Works closely with Business Unit Controller to capture, assess and consolidate results
• Drafts key reports such as annual cost and expense budgets, cost rates, cost and expense forecasting, monthly utilization, headcount, revenue backlog analysis, and/or gross profit for assigned area
• Updates predefined reports
• Attends project meetings as applicable to support assigned areas
• Attends project kick-off meetings to capture and process relevant data for set up of newly awarded projects onto financial systems and schedules
• Attends monthly project review (MPRs) meetings to ensure understanding/concurrence of project status, potential issues and the accuracy of the forecast
• Monitors the overall health of assigned projects including but not limited to revenues, gross profit, receivables, and unbilled amounts as well as project close outs and reconciliations

Bus Project Financial Analyst II

Data Engineer

• Act as a hands-on technical lead who not only defines the architecture but also codes, deploys, and maintains scalable ETL pipelines and data structures
• Spearhead the technical implementation of the Translational Data Lake data ingestion, managing the ingestion of complex datasets (genomics, proteomics, imaging, lab data, etc.) into modern cloud architectures
• Lead data engineering projects beyond the Data Lake, designing bespoke integration solutions for diverse scientific data sources across the Research organization
• Design and script automated procedures to normalize unformatted data from external vendors (CROs) into a structured Common Data Model (CDM)
• Partner with various functions in Research and IT to align infrastructure with scientific needs, ensuring solutions are robust, FAIR-compliant, and scalable
• Develop and communicate the technical vision for biomarker data integration and reuse
• Architect and implement scalable ETL procedures, APIs and front-end tools for data access and visualization
• Engage stakeholders to gather requirements and incorporate feedback into design
• Lead user acceptance testing (UAT) and ensure high-quality deliverables
• Collaborate with IT and Translational leads to align infrastructure and governance processes
• Champion FAIR principles and interoperability across translational and clinical programs

Senior Biometrics Data Engineer

Content Writer

• Collaborate with cross-functional teams to develop and manage the publication strategy
• Write, edit, and review manuscripts, abstracts, and presentations
• Ensure compliance with regulatory guidelines and standards
• Manage timelines and coordinate with external vendors and authors

Medical Writing Manager – Publications

• Project-specific management responsibilities for medical writing staff members
• Recommends courses of action on salary administration, interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling
• Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods
• Reviews and edits departmental work products for completeness, accuracy, and overall quality
• Ensures adherence to Sponsor objectives and that quality standards are maintained
• Supports the company’s MW leadership team in the planning, development and implementation of document development strategies and development and presentation of quarterly business updates
• Assists with the preparation of budgets and timelines for medical writing activities
• Assists with budgeting, revenue, invoicing, and forecasting as requested
• Contributes to departmental metrics by assisting in the tracking, maintaining and reviewing project metrics
• Supports business development by assisting with proposal and costing development as well as bid defenses and customer meetings
• Builds and maintain relationships with internal and external customers
• Forms, maintains and leads productive cross-functional working teams, including addressing issues that arise
• Reviews performance of medical writing personnel (direct reports)
• Develops and maintains departmental SOPs and templates and acts as resource for implementation
• Participates in the planning, writing, and assembly of medical writing deliverables, as needed
• Performs senior reviews of medical writing deliverables

Manager/Associate Director, Medical Writing – Regulatory

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 and 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
• 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
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.

Clinical Research Associate, CRA II – Sr CRA

Software Engineer

• Uses R, 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
• Follow 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 or 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
• Conducts effective internal meetings (appropriate in format, frequency and attendance)
• Distributes relevant information in advance
• Ensures minutes are promptly and accurately distributed
• Follows action items through to completion, and maintains order and focus of meetings, working toward consensus
• Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business
• Accountable for on-time delivery across concurrent programming deliverables
• Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed
• Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions
• Acts as the lead statistical programmer
• Directs the programming activities of other programming personnel and monitors progress on programming deliverables
• Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design
• Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities
• Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor
• Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process
• Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions
• Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures
• Contributes technical expertise to the development of programming tools and macros for standardization and efficiency
• When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards
• When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents (i.e. DEFINE.XML)
• When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards
• Transfers deliverables
• Performs other work-related duties as assigned

Principal Statistical Programmer – North America

Project Manager

• 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

Project Manager II

• 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.
• Develops contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
• 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; ensures adequate documentation of each communication.
• 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.
• Responsible for quality and completeness of TMF for assigned projects.
• Accountable for the financial performance of each project assignment.
• Demonstrates mastery of current business unit therapeutic environment and drug development trends and facilitates the development of knowledge for more junior staff.

Senior Project Manager

Procurement

• May provide independent resources solution management of one or more resource subsets/roles
• Conducts meetings with relevant internal stakeholders and circulates information back to respective management team
• Effectively partners with identified Business Units to manage and support demand planning processes and resource requirements
• Effectively supports centralized resourcing efforts and internal stakeholders in resourcing process by supporting the management and maintenance of data integrity within the global resourcing tools, updating trackers, running reports and queries
• Analyzes resource assignments, skillsets, and availability to support recommendations for potential assignment opportunities of global employees and contingent workers to Business Units
• Ensures data integrity in all source systems
• Supports and educates partners on use of global resourcing toolsets and processes
• Supports TA/candidate recruitment efforts, as needed

Senior Clinical Resourcing Specialist

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
• 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 – CSR and Protocols

Manager

• Collaborates with major functional areas including, but not limited to: Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management and Medical Writing
• Identifies and evaluates fundamental issues pertaining to Site Start-Up, project regulatory pathway, successful patient enrollment, interpret data on complex issues, make good business decisions, and ensure solutions are implemented
• Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk identification, mitigation and management
• Develops and maintains relationships with customers in alignment with their assigned projects
• Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed
• Provides oversight of all project start-up deliverables which encompasses all activities from site selection through site activation ready and into the life cycle maintenance of projects
• Assumes accountability on start-up deliverables including, but not limited to: Site Identification and selection Start-up and life cycle maintenance regulatory activities (submissions, oversight of communication to competent authorities/ethics committees, import/export licenses and extensions, study maintenance and amendment submissions) Oversight of delivery of executed clinical trial agreements and investigator budgets with investigator sites, including any require amendments Establishing and overseeing Essential Document collection leading to site activation Overall SSU timelines, prior to and following site activation. Including any realignment required due to amendment needs
• Develops plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes. Complies all controlled document requirements and other requirements to ensure quality deliverables
• Develops and manages integrated site start-up timelines and reports weekly progress including plans to address potential timing risks/gaps
• Prepares and presents overall SSU strategy and status at client meetings and communicates outcomes to project team
• Reviews the project SSU budget with the functional leads, PM, and the SSU Business Unit Controller against project milestones and budget to ensure project profitability. Takes corrective measures where necessary to keep projects in line with budget and gross profit expectations
• Uses professionally recognized tools for planning and management of scope, timeline, and resources and ensures effective budget management
• Prepares the core submission documents and core clinical trial application dossier for amendments during life cycle maintenance of the projects
• Performs a Regulatory Impact Assessment on core amendment submission documents and communicates any risk mitigation to Sponsor/Project teams and oversees review for Regulatory Impact Assessment for 2nd level to identify gaps, highlights any risk management to Sponsor/Project teams
• Assists in initial or amendment updated development of master Subject Information Sheet (SIS) /Informed Consent Form (ICF) in collaboration with the PM and Medical Department
• Oversees collation, quality review, and submission of country-specific applications
• Contributes to change initiatives across and within the SSU department
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements
• Performs other work-related duties as assigned

Site Activation Manager – Logistic, Import & Export Experience

• Coordinate and support Clinical IRC activities across risk, projects, reporting, and administrative functions
• Assist with Clinical and Finance initiatives through scheduling, tracking, and reporting
• Serve as a systems coordinator for project management tools, budgeting, resource tracking, and review reporting
• Support Clinical Risk activities, including operational incidents, audits, and regulatory requests
• Assist with project budgeting, resource tracking, prioritization, and status reporting
• Ensure timely reporting for daily, weekly, monthly, and quarterly deadlines, as well as ad-hoc requests
• Produce resourcing updates, expense reports, organizational charts, and metrics for leadership
• Maintain committee rosters, reviewer assignments, conflicts-of-interest tracking, and related records
• Track and validate grant or contributed services information from clinical peer review committees
• Support technical or clinical documentation (SOPs, process documents, reports) as capacity allows