Syneos Health

Customer Support

• Create site-specific agreements using approved templates and study-specific parameters
• Assist with and process contract amendments throughout the lifecycle
• Track the progress of contract and budget negotiations to support turnaround time expectations
• Create and maintain organized folders within SharePoint
• Upload, organize, and maintain documents in Veeva; ensure system accuracy and completeness
• Route documents for signature within the Contract Lifecycle Management (CLM) system
• Communicate directly with clinical sites to gather required documentation and resolve issues efficiently
• Merge documents and prepare finalized files for internal and external distribution
• Maintain trackers and internal systems with consistent, real-time updates

Clinical Contract Support Specialist – Sponsor Dedicated

Director

• Provides overall strategy and direction of clinical trials, processes and procedures
• Acts as Scientific Director / consultant as required by the needs of the projects
• Acts as a primary senior-level contact for customers
• Participates in customer proposals, Request for Information (RFIs), presentations, proposal defenses and Steering Committees
• Provides scientific/regulatory oversight and project/therapeutic training to project teams
• Interacts and collaborates with the Medical Writing department in the preparation of clinical development plans, protocols, investigator brochures, and medical/clinical reports, as required
• Responsible for coordinating the acquisition of necessary medical/scientific input from outside experts/consultants/advisors
• Represents the Company by attending industry meetings, speaking engagements, participating in booth exhibitions, etc., and by publishing scientific or industry related articles in industry journals
• Participates in the development of Standard Operating Procedures (SOPs), medical/scientific tools, training, staffing requirements, etc.
• Interacts with senior management and contributes scientific/medical input to other departments, as appropriate

Senior Director, Strategy & Delivery – Neurology

Business Development Rep

• Lead the client engagement strategy
• Identify and engage key stakeholders
• Develop bespoke integrated product offerings
• Use Business Insights to understand market landscape
• Analyze industry activity and develop an annual business plan
• Participate in the development and implementation of the sales plan
• Proactively focused on developing a strong pipeline of work
• Develop account strategies for all appropriate clients
• Accountable for providing strategic direction and customer insights
• Expand customer accounts by leveraging strong relationships
• Ensure high visibility within the customer organization
• Maintain accurate records within salesforce.com
• Maintain professional level of knowledge in industry trends
• Participate in updates to provide management insight
• Actively participate at professional meetings and conventions

Executive Director – Strategic Business Development

Clinical Research

• Responsible for all aspects of the development, coordination, and implementation of Phase 1 clinical research studies at the organization's facilities.
• Collaborates with the principal investigator, liaisons between research subjects, client teams, investigators, and clinic operations teams, and plans logistics and resource usage.
• Tracks study progress in alignment with project milestones, client deliverables, and budget, and follows applicable regulations globally and by region.
• Oversees their area of responsibility, planning, prioritizing, and/or directing the responsibilities of employees.
• Delivers operational results that have direct impact on immediate or short-term department results.
• Manages a team of individual contributors and/or Supervisors.
• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
• Oversees site interactions post activation through site closeout.
• Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
• Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines.
• Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements.

Senior Clinical Trial Manager – Clinical Trial Manager II

• Oversee a portfolio or program of projects
• Ensure all studies within a program or portfolio are conducted to reflect the therapeutic or client specific requirements
• Represent company to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively
• Ensures the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) or appropriate regulatory requirements, and International Conference on Harmonization (ICH) guidelines to fulfil all federal and local regulations
• Manages the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses
• Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools
• Ensure and maintain an in depth therapeutic and/or client specific knowledge and expertise for the assigned portfolio
• Apply study specific learning across assigned portfolio of studies/clients
• Lead and ensure consistency in contingency planning and risk mitigation strategies to ensure successful delivery
• May lead operational input to proposal development and pricing including proposed operations strategy
• Drive performance improvement, operational efficiencies and innovative strategies
• May provide line management oversight and contribute to leadership of Project Management as an operational and therapeutic area expert

Clinical Project Director

Medical writer

• Mentor and lead less experienced medical writers
• Manage and coordinate medical information activities across departments
• Respond to escalated queries from internal and external teams
• Create or update scientific response documents based on provided templates
• Conduct literature searches and validate relevant inclusions
• Develop various documents such as clinical journal manuscripts and abstracts
• Identify solutions to writing process issues
• Interact with various department staff to produce deliverables
• Serve as a peer reviewer on internal review teams
• Adhere to regulatory standards and procedures

Senior Medical Writer, Medical Information Writing

• Line Management responsibilities including administrative oversight, professional development, performance appraisals, and mentoring/coaching of staff
• Maximizes development of staff through guidance, coaching, training, and performance management
• Provides leadership, direction and management to staff related to monitoring, enrollment and/or site management to ensure deliverables are met
• Contributes to operational initiatives and continuous improvement
• Uses metrics, dashboards, and reports to analyze staff performance for compliance, quality, operational and financial delivery
• Serves as a point of escalation for internal and external customers
• Reviews workload, utilization, productivity, and quality for staff in reporting chain
• Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level
• Works closely within appropriate business unit/region to ensure staff performance on studies and correct deficiencies as identified by staff, clients, and auditors
• Acts as a point of contact for performance related concerns for assigned staff related to monitoring, enrollment and/or site management
• Provides operational oversight and guidance to support prioritization of activities, reviews and monitors the work performed, metrics compliance, and development of contingency plans, among others
• May support fiscal management tasks of projects related to monitoring, enrollment and/or site management
• Support the assessment of overall staff growth and actively participate in the selection and hiring process
• Proactively works to ensure staff retention and turnover rates remain within expected levels
• Ensures all staff follows required training and completes the required documentation
• Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WI) and compliance with federal, local guidelines, and ICH GCP
• Provides regular compliance updates to management accordingly
• Manages the resource availability and assignment for direct reports, supporting direct reports who ensure assigned projects are suitably resourced and staffing needs are identified in a timely fashion, resolving potential resourcing conflicts to facilitate mutually beneficial resolutions
• Liaises with resourcing management on active awarded and proposal project assignments
• Participates in cross-organizational initiatives; champions change management and implementation of initiatives
• Identifies needs and makes recommendations for process improvement and efficiencies
• Supports staff in marketing activities, client presentations and proposal/Bid Defense development
• Participates in audits of clinical trial management delivery and prepares others for participation in audits

Associate Director, Clinical Delivery Management, RWE

• 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
• Accountable for all project deliverables for assigned projects
• Develops contingency planning and risk mitigation strategies to ensure successful delivery of study goals
• Identifies and implements performance improvement and operational efficiencies
• 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
• Works with Business Development and the Proposal/Contracts groups to develop proposals for Customer requested opportunities. Works with this team to develop budgets and scope of work for the final contract
• Responsible for quality and completeness of TMF for assigned projects
• Accountable for the financial performance of each project assignment
• Accountable for all project deliverables for each project assigned
• 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
• Demonstrates mastery of current business unit therapeutic environment and drug development trends and facilitates the development of knowledge for more junior staff
• Facilitates team training in accordance with protocol and/or project requirements including therapeutic, protocol specific, and process training
• Serves as team leader and line manages and mentors other project management and clinical monitoring staff
• Facilitates team building and communication
• Ability to successfully deliver a project through successful delegation and oversight of project and functional leads

Associate Project Director

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

• 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