Syneos Health

Software Engineer

• Utilize primary development tools to design, write, validate, and maintain software
• Generate and maintain all required documentation for clinical programming projects
• Participate in project meetings and provide constructive feedback
• Monitor applications for workflow alerts and performance issues
• Provide leadership, training, and support to other department members.

Principal Clinical Programmer, DM SAS

Clinical Research

• Collaborates with representatives from other functions to plan, execute and analyze all biomarker aspects (including genomics) of clinical studies or biomarker studies in the role of the biomarker statistician and assumes the role of project biomarker statistician under guidance of an experienced statistician
• Develops the Biomarker Evaluation Plan for the study as appropriate, ensuring overall consistency within and between projects
• Provides statistical input in clinical development discussions, and usage of AI and ML approaches.
• Facilitates the overall organization and coordination of statistical activities regarding biomarker research and development activities for specific studies and projects
• Conduct and design advanced data analysis for genomics and biomarker statistics, including statistical programming, and design complex analysis algorithms.
• Assumes responsibility for the production and accuracy of the Biomarker Evaluation Report with respect to statistical deliverables and interpretation of the results.
• Works independently at routine and complex statistical questions, modeling and tasks.
• Develops and implements standard processes for the analysis of routine (parts of) biomarker assessments.

Principal Biostatistician – Biomarker

Clinical Operations

• Lead and manage Clinical Operations teams to ensure timely delivery of high-quality clinical study activities
• Oversee operational performance, resource allocation, and quality outcomes while fostering staff development
• Provide training and consultation to support project deliverables
• Collaborate across departments to optimize resource use and contribute to broader operational initiatives
• Ensure quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WI) and compliance with federal and local guidelines

Associate Director, Clinical Operations

• Coordinate Phase III clinical research studies across European, ensuring all aspects of the study are meticulously planned and executed
• Participate in and manage project meetings and conference calls with CROs, vendors, and multi-functional teams.
• Able to anticipate obstacles and proactively develop solutions to achieve project goals.
• Participate in abstract presentations, oral presentations and manuscript development activities.
• Interact and cooperate with individuals in other functional areas to address routine study issues.
• Assist in training for Clinical Trials Management Associates (CTMAs) and Clinical Project Assistants (CPAs).
• Assist in selecting CRO's or Vendors.
• Coordinates CROs and Vendors.
• Responsible in updating of study timelines.
• Ensure adherence to global and regional regulations and guidelines, staying up-to-date with any changes or updates.

European Clinical Trial 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.

Clinical Project Manager – Regional & Global Experience

Full-stack Engineer

• Execute FinOps policies, optimization strategies, and savings initiatives across cloud services.
• Partner with Cloud Engineering to improve cost telemetry and allocation accuracy.
• Identify optimization opportunities by analyzing cost signals and translating insights into actionable work.
• Track, validate, and report savings realization against enterprise targets.
• Embed cost governance into platform and operational processes.

Principal Engineer

Engineer

• Troubleshoot and resolve issues related to provisioning, deprovisioning, privilege management, and attestation
• Deploy and configure Saviynt, Active Directory, or Entra ID changes and enhancements, guaranteeing adherence organizational policies and regulatory compliance
• Assume end-to-end ownership for assigned IAM core processes ensuring organizational compliance with best practices and security policies
• Manage tools and scripts for monitoring system performance, completeness, and accuracy and identify opportunities to incorporate automation for auto-recovery or correction
• Create and maintain comprehensive documentation for solution designs, configurations, and best practices
• Provide training and support to IAM support teams on processes and architecture
• Collaborate with IAM peers and architects on Saviynt, Active Directory, and Entra ID solutions including requirements analysis, solution design, application integration, testing/validation plans, and the establishment of security controls
• Provide guidance and mentorship to junior engineers and foster the advancement of technical skills across the team
• Promote a culture of continuous improvement and knowledge sharing

Senior Engineer

Director

• Carries out vision and strategic objectives, motivates and enables the team to perform to a consistently high standard
• Recommends courses of action on salary administration, interviewing and selection, terminations, professional development, performance appraisals, position description preparation, and employee counseling.
• Works with and advises staff on administrative policies and procedures, technical problems, priorities and methods.
• Acts as an ambassador for the team and owns a function (training, smaller therapeutic area, triage, etc.) under the leadership of the Director to drive communications between Proposals and other Departments - influencing, communicating and negotiating.
• Strategically and independently develops long term initiatives based on business unit/team priorities that align with leadership vision to drive ongoing improvement/growth.
• Ensures high quality and timely delivery, through direct involvement on key deliverables, providing strategic input, oversight of the management team, and ensuring that quality control processes are followed.
• Actively participate in training and mentoring of junior staff across team, providing motivation and promoting staff retention.
• Monitors subordinate team's workload ensuring timelines are being met, issue resolution etc. - participates in workload management discussions.
• Communicates and enforces departmental processes, ensuring adequate training is available and that processes are in compliance with corporate policies and local regulations.
• Works with management team and other relevant parties within the Company as required to streamline budget and proposal tools, ensuring accurate bidding and the production of high-quality proposals.
• Continually evaluates and recommends alternative approaches and/or technologies to improve the overall proposal processes.
• Provides updates to management regarding department budget, progress, key performance indicator targets, achievements, and business issues.
• Participates in departmental initiatives and process improvements.
• Attends client meetings as needed.
• Performs other work-related duties as assigned. Minimal travel may be required (up to 25%)

Associate Director – Proposals/RFIs

• Accountable for and provides management support and direct supervision to Clinical Operations staff
• Collaborates and oversees Clinical Operations Team to ensure fulfillment of customer requirements
• Provides training, consultation and oversees metric compliance and quality related to operating activities of assigned staff
• Manage staff by establishing goals that will increase knowledge and skill levels
• Work closely within appropriate business unit/region to ensure staff performance on studies
• Organize and chair clinical staff meetings at regular intervals
• Facilitate and support project and team/country reviews with Clinical Operations staff

Manager, Clinical Operations

Medical Director

• Provides after-hours medical coverage for clinical studies.
• Adheres to all enterprise policies, work instructions, standard operating procedures, and project plans.
• May support responses to Requests for Proposals (RFPs) or Bid Defense Meetings (BDMs), upon request.
• May represent the Company at scientific meetings, upon request.

Medical Director – Psychiatry

Project Manager

• Creates and maintains the Trial Master File Management (TMF) Plan
• Routinely reviews the TMF to ensure quality, completeness and inspection readiness
• Coordinates and monitors study deliverables across functional departments and vendors
• Assists with interim analyses, database snapshots and locks
• Provides vendor management, ensuring deliverables are met
• Assists with financial performance and metrics for reporting
• Participates in representing the company to the client
• Facilitates team training in accordance with protocol and project requirements

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, driving query resolution to closure within agreed timelines
• Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
• Verifies site compliance with electronic data capture requirements
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security
• Verifies the IP has been dispensed and administered to subjects/patients according to the protocol
• Verifies issues or risks associated with blinded or randomized information related to IP
• Reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness

Experienced Clinical Research Associate – Oncology

• 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.
• Conducts Source Document Review of appropriate site source documents and medical records.
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete.
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
• Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture.
• Verifies site compliance with electronic data capture requirements.
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
• Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
• 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).

Experienced Clinical Research Associate – Full-Service, Ophthalmology

Public Relations

• Innovate and collaborate with passionate problem solvers
• Accelerate the delivery of therapies
• Work alongside diverse teams of experts
• Solve challenges for prestigious healthcare companies

PR Stats Programmer

• Provides medical oversight of assigned clinical studies.
• Interacts with senior management, customers, and project teams to ensure subject safety and scientific integrity of clinical studies.
• Provides therapeutic area medical input and consultation to internal colleagues and customers.
• Participates in business development meetings.
• May participate in scientific meetings, upon request.
• Performs the duties of Medical Monitor.
• Often serves as primary medical contact for customers for assigned clinical studies.
• Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department.
• Responsible for protocol design and development, upon request.
• Provides input into protocol amendments.
• Develops and delivers project-specific and therapeutic training to project team members and clinical site staff; provides training to customer staff as needed.
• Provides medical and therapeutic input to Study Start Up, Feasibility, and Subject Identification efforts.
• Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data.
• Provides after-hours medical coverage for clinical studies.
• Adheres to all enterprise policies, work instructions, standard operating procedures, and project plans.