Syneos Health

Medical Director

• Provides medical oversight of assigned clinical studies in the duty as a medical monitor
• Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department
• Develops and delivers project-specific and therapeutic training to project team members and clinical site staff
• Provides medical input into data collection tools, monitoring plans, and review and analysis plans
• Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data

Senior Medical Director – Immunology/Rheumatology

Data Specialist

• Responsible for project management of all the data management services for the assigned projects
• Ensures the contracted Non CRF Data Management activities for projects are carried out by the Company in accordance with the executed contract and the Sponsor’s expectations
• Acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups
• Coordinate the work of the assigned Data Management/Data Operations team
• Communicate independently, proactively and clearly to internal and external stakeholders, able to work autonomously on the non-CRF data strategy for the study team
• Take ownership of non-CRF data
• Provide comprehensive assessment to identify all non CRF data types defined in the study protocol via protocol review and team discussion (including amendments)
• Support implementation of patient enrollment and randomization strategy responsible for set up of IXRS UAT
• Implement, maintain and approve non CRF Vendor Transfer Agreements/plans/ specifications
• Confirm non CRF vendor specifications can be met and provide expertise on testing/results
• Effectively communicates non-CRF data collection deliverables, status of work and data issues to the Client study lead and other study team members
• Coordinates cross-functional non-CRF tasks with strong understanding of downstream processes and stakeholder needs and impacts
• Receive, process, and deliver non CRF test and production data
• Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
• Provides project specific training to internal and external audiences as required
• Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed
• Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management
• Plan, manages and requests resources for assigned projects
• Develop and maintain project plans, specifications and documentation in line with SOP requirements
• Maintains documentation on an ongoing basis and ensures that all TMF filing is complete and up to date
• Participates in, and presents at internal, Sponsor, third-party, and investigator meetings
• Plans for and creates necessary documentation to support internal and external audits; participates in such audits
• Trains and mentors data management staff
• Prepares input for, and participates in proposal bid defense meetings
• Maintains proficiency in Data Management systems and processes through regular training
• Performs other work related duties as assigned

Project Data Management, Data Acquisition Specialist

General

• Establishes, maintains and updates training material for site contracts lead team and site contract negotiators.
• Serves as subject matter expert within the organization equipped to help resolve global site contracting issues, and escalation point within the Company for internal customers to seek assistance.
• Oversees negotiations of clinical study agreements (CTA´s) on a study level and drives CTA document finalization and execution, including contractual language & terms, financial attachments, and investigator grant budgets in collaboration with a global team of site contract & budget negotiators.
• Provides oversight of contact & budget negotiations status and manages escalation of out-of-parameter queries on budgetary and contractual requests to sponsor decision-makers in all regions of study conduct. Provides consultation during escalation of out-of-parameter queries as needed.
• Advises study team and Sponsor stakeholders on industry trends, norms, and emergent developments surrounding site contract and budgetary negotiations. Provides consultation on potential risks and mitigation tactics for negotiation issues pertaining to overall study start-up needs.
• Acts as first-line subject matter expert for all such CTA elements on assigned studies for internal and sponsor stakeholders alike. Advises stakeholders on issue resolution within the context of assigned studies. May seek additional support from internal support structures as needed.
• Plans contract execution strategy for assigned studies—including forecast of site-specific contractual execution timelines with as much accuracy as possible—and coordinates with internal study team stakeholders to ensure that CTA strategy is aligned with overall study start-up plans and expectations overall. Manages expectations of internal and sponsor study team regarding global CTA negotiations for assigned studies.
• Coordinates communications between study team stakeholders and global team of site-facing site contract & budget negotiators including roll-up of all status updates to regular team forum. Participates in regular study calls to facilitate communication as needed.
• Works closely with internal stakeholders and with Sponsor to prepare site contractual templates, including payment terms, and study-level negotiation parameters and processes within Company standards in order to drive successful negotiation of contracts and budgets.
• Establishes strong working relationships and collaboration with Sponsor to ensure site contractual templates fit into the global strategy set for the program.
• Identifies possible site contractual and investigator budgetary document or process operational risk and proactively works to provide solutions. Establishes strong working relationships with customer and internal project teams. Escalates deviations to senior management and is equipped to resolve issues with Quality Assurance.
• Creates and maintains document status reports, and updates department tools/systems and team members on a regular basis; ensures appropriate documentation is maintained.
• Collaborates with internal and external legal, finance and clinical operations departments, including communicating and explaining legal and budgetary issues.
• Manages site and study level discussions with internal and sponsor team stakeholders around fair market value of investigator budgets and payment terms within corporate and industry standards during negotiation with sites.
• Identifies best practices, investigates root causes of fundamental issues and problems for projects and recommends solutions.
• Trains and mentors less experienced staff members on department Standard Operating Procedures (SOPs), processes, tools and templates and ensures quality of teamwork products.
• May support BU and organization through help desk and other defined pathways to resolve and deescalate issues.
• May identify and lead internal team training and/or process improvement initiatives.
• Participates in business development presentations as a subject matter expert in site contracts and investigator budget management within the Company
• Performs other work-related duties as assigned.

Senior Site Contracts Lead

Contracts Specialist

• Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
• May lead (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
• Provides support to SSUL to agree on country template contract and budget. Produces site-specific contracts from country template. Provide support in submissions for proposed contract and budget for site.
• Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues.
• Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
• Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
• Provides supports to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
• Work with Contract Managers and team members with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues.
• Supports in generating amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; and initiates and introduces creative ideas and solutions.
• Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time.
• Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.
• Facilitates the execution of contracts by company signatories.
• Maintains contract templates and site specific files and databases.
• Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs) and ensures quality of team work products. Maintains and updates training material for site contract team.
• Acts as a communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.

Site Contracts Specialist II/Sr

Software Engineer

• Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
• Works to ensure that outputs meet quality standards and project requirements.
• Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings.
• Keeps project team members informed of programming progress and issues requiring their attention.
• 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 and sponsor requirements.
• Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
• Conducts effective internal meetings (appropriate in format, frequency and attendance). 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.
• Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted.
• 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.
• Transfers deliverables. Performs other work-related duties as assigned.

Senior Statistical Programmer, Clinical Pharmacology

Content Writer

• Contribute to the design and execution of Real World Evidence (RWE) studies
• Develop study protocols and materials for congress presentations and manuscripts
• Prepare draft study reports and external publications
• Primary contact for assigned projects

Medical Writing and Research Manager, RWE – Epidemiology – Study Protocols, SAPLans, Study Reports, Abstracts

Project Manager

• Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients.
• We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans.

Clinical Specialist

• Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
• May lead (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
• Provides support to SSUL to agree on country template contract and budget.
• Produces site-specific contracts from country template.
• Provide support in submissions for proposed contract and budget for site.
• Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues.
• Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
• Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
• Provides supports to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
• Work with Contract Managers and team members with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues.
• Support in generating amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; and initiates and introduces creative ideas and solutions.
• Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time.
• Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.
• Facilitates the execution of contracts by company signatories.
• Maintains contract templates and site specific files and databases.
• Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs) and ensures quality of team work products.
• Maintains and updates training material for site contract team.
• Acts as a communication liaison between site contracts staff and internal and external customers.
• Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues.
• Prepares correspondence as necessary.
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.

Clinical Site Contracts Specialist – Site Agreements, Budget Experience

Strategy

• Provides oversight for all assigned projects to ensure study launch, conduct and closeout occur according to the Customer’s and company's contractual agreement
• Forecasts, prioritizes and directs staff to achieve on-time sponsor deliverables
• Collaborates with Therapeutic Strategy and Innovation team to provide operational input
• Drives preparation and facilitation of bid defense meetings
• Provides oversight to project management teams
• Actively mentors junior project delivery oversight staff
• Develops and maintains knowledge of evolving trends related to therapeutic area

Senior Director, Strategy & Delivery

Safety Specialist

• Collaborate with passionate problem solvers
• innovate as a team to help our customers achieve their goals
• processing of information may include filtering, cleansing, migrating, analyzing, reporting, filing or publication of data and information

Compliance

• Collaborate with innovators at every point across the drug development continuum
• Understand customer needs and represent them in the solutions
• Innovate as a team to help customers achieve their goals
• Act with a drug development mindset applying deep expertise

Senior Regulatory Consultant

Principal

• Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
• May be responsible for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
• Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work.
• Provides independent review of project work produced by other biostatisticians in the department.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews SAS annotated case report forms (CRFs) and database design to ensure protocol criteria are met.
• Conducts and participates in verification and quality control of project deliverables.
• Implements company objectives and create alternative solutions to address business and operational challenges.
• Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives.
• Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met.
• Provides statistical programming support as needed.
• Coaches and mentors other Biostatistics staff.

Senior Statistician – Sponsor-dedicated, R Shiny experience

• Responsible for the quality deliverables at the country level
• follows project requirements and applicable country rules with moderate oversight from the SSU Country Manager
• Works within the forecasted submission/approval timelines and ensures they are complied with
• tracks milestone progress in agreed upon SSU tracking system in real time
• if forecasted timelines are not reached: investigates and provides clear rationale for delays
• provides support on contingency plan to mitigate impact
• escalates the issue as soon as identified
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract
• escalates discrepancies in a timely fashion
• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner
• keeps training records updated accordingly and ensures timesheet compliance
• Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements
• Follows the project direction provided by the designated country start-up advisor (CSA) and SAM
• May serve as a point of contact for the PM/SAM (or designee) during start-up on allocated projects
• Complies and/or reviews essential document packages for site activation and may also be involved in essential document collection from site
• Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required
• Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA and other local regulatory authorities as needed within the country
• includes safety notifications as required by local rules, with moderate oversight from the SSU Country Manager
• May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues
• Oversee site activation end to end process at country/ site level

Country Study Startup Specialist – Part Time

Data Analyst

• Identifies and documents emerging business requirements; Questions business partner and knowledge worker preferences to identify unique value drivers
• Capture business requirements, functional and nonfunctional requirements
• Create and maintain technical documentation, including specifications, user guides and reports
• Prioritize competing business demands, elicit high-level business requirements, and assess the risks of various solution options to different options
• Communicate between business units, technology teams, and support teams, aligning the needs of business units with the capabilities delivered by information technology and serves as a “translator” between those groups
• Manages requirements to meet performance expectations
• Facilitate communication between technical teams and non-technical business stakeholders to ensure alignment and clarity
• Present ideas in a concise, focused manner
• Surface potential impacts of the solution on all stakeholders
• Articulates the role of technology in terms easily understood by business constituencies
• Mentor and coach junior team members

Senior Tech Business Analyst, Business Analysis, Product Management, Data Analysis

QA Automation Engineer

• The Principal Engineer provides technical leadership for delivering standardized, compliant, and scalable infrastructure foundations (IaaS) through automation, operating as a predictable internal service provider.
• This role owns infrastructure standards and configurations, base images, capacity and quota management, lifecycle and patching execution, and integration with foundational services such as network, DNS/Infoblox, storage (NetApp), and identity.
• The Principal Engineer establishes and enforces infrastructure-as-code standards, image factory and lifecycle automation, and cloud-native quota/capacity modeling to ensure repeatable provisioning and operational rigor.
• Operating within guardrails that prohibit bespoke builds, the role drives an automation-first mindset and implements controls that prevent manual variance so all consumption flows through approved patterns defined by Architecture and Engineering.
• Own and evolve standardized infrastructure foundation patterns, configurations, and base images for Windows and Linux platforms.
• Build and operate an automation-first provisioning model, ensuring all consumption flows through approved patterns and engineering-defined pipelines (no bespoke/manual builds).