Jobs at Syneos Health

Conduct on-site and remote monitoring to ensure GCP and protocol compliance; develop monitoring tools, plans, SOPs and training; coordinate site visits, track study progress, document findings, write monitoring reports and action plans; collaborate with investigators and cross-functional teams to resolve issues and support clinical trial operations.

Conduct site qualification, initiation, monitoring, management and close-out visits (on-site or remote) ensuring ICH/GCP and protocol compliance. Verify informed consent, source data, CRF accuracy, investigational product handling, and ISF/TMF reconciliation. Document findings, drive query resolution, support recruitment/retention, prepare for audits, and collaborate with sponsors and site teams. For late-phase studies, perform chart abstraction and local site support.

Support clinical monitoring and site management activities: maintain Trial Master File and project files, track clinical and regulatory documents, manage site communications and shared mailboxes, coordinate supplies and meetings, assist with CRF handling and data tracking, and complete assigned training to ensure protocol compliance.

Lead and deliver interdisciplinary clinical research projects ensuring GCP/ICH compliance, timeline, budget, quality, and inspection readiness. Serve as primary client liaison, coordinate partners, manage project teams and support staff, prepare reports/presentations, mitigate risks, and support business development and training activities.

Provide administrative and site-support activities for clinical studies, including TMF and project file maintenance, site communication and document tracking, shipping/site supply coordination, mailbox and meeting support, and assistance to clinical monitoring staff to ensure protocol compliance.

Provide operational support for clinical studies: assist site management and monitoring, maintain Trial Master File and project documents, track clinical/regulatory documents and databases, manage site communications and shared mailbox, coordinate shipments and site supplies, take meeting minutes, handle CRFs/queries as needed, and complete required training.

The Site Activation Specialist I/II supports site activation by managing project timelines, ensuring regulatory compliance, and facilitating communication with stakeholders. Responsibilities include document submission, budget management, and problem-solving within clinical trial processes.

Provide HR operations support including onboarding/offboarding, benefits setup, HRIS data maintenance, responding to employee inquiries via Workday Help/ServiceNow, ensuring compliance, supporting audits, documenting processes, and collaborating with HR Centers of Excellence.

Lead on-site and remote monitoring of clinical trials, ensure GCP and regulatory compliance, develop monitoring tools and SOPs, mentor junior staff, manage documentation and monitoring reports, identify and resolve protocol deviations and data issues, and collaborate with cross-functional teams to ensure successful trial execution.

Prepare, analyze, and deliver financial reports, forecasts, budgets, and metrics for assigned areas. Build subject visit forecasts using protocol and CTMS data, investigate financial variances, provide commentary to senior management, and support ad-hoc finance projects and process improvements.

Provide operational HR support across the employee lifecycle: onboarding/offboarding, benefits setup, HRIS data maintenance, respond to HR inquiries via ticketing, ensure compliance, support audits, update SOPs, collaborate with Centers of Excellence, and manage confidential information.

Lead operational execution of a complex Phase 2b inflammation trial from start-up through closeout. Independently manage day-to-day study operations, timelines, risks, vendor/CRO oversight, cross-functional leadership, study documentation, budget tracking, and training. Drive issue resolution, mentor junior staff, and implement process improvements in a sponsor-dedicated, fast-paced environment.

Perform on-site and remote clinical site activities including qualification, initiation, monitoring, interim and close-out visits. Conduct source data verification, informed consent checks, IP accountability, ISF/TMF reconciliation, query resolution, and documentation. Support audit readiness, train/mentor junior CRAs, manage site communications, and contribute to study operational tasks. RWLP level includes chart abstraction, site identification, consent development, and input to RFPs and case report form design. Significant travel required.

Serve as an RBQM and Central Monitoring subject matter expert: assess protocols, lead study-level risk assessments, design RBM/RBQM strategies, leverage centralized monitoring analytics, advise sponsors and stakeholders, mentor colleagues, and drive risk mitigation and quality oversight across global clinical trials.

Prepare, analyze, and deliver financial reports, budgets, forecasts, and metrics for assigned areas. Investigate financial results, produce monthly commentary, support cost and revenue analyses, build subject visit forecasts using protocol/subject data, and provide insights on profitability and growth. Support ad-hoc reporting and finance projects.

Lead day-to-day delivery of patient concierge projects from handover to closeout, manage budgets, vendors, and coordinators, ensure GCP/SOP/regulatory compliance, coordinate patient materials and reimbursements, run project reviews, and support business growth and cross‑functional collaboration.

Conduct site qualification, initiation, monitoring (on-site and remote) and close-out visits ensuring ICH/GCP and protocol compliance. Perform source document review, CRF verification, query resolution, IP management, ISF/TMF reconciliation, and documentation. Support recruitment/retention, audit readiness, training, and cross-stakeholder collaboration; may perform chart abstraction in late-phase real-world studies.

Process and triage ICSRs: enter and code safety data, compile narratives, perform MedDRA coding, literature screening, xEVMPD submissions, duplicate identification, quality review, maintain safety tracking and TMF/PV master files, ensure regulatory compliance and support audits.

Lead and mentor biostatistics teams for ophthalmology clinical trials across the study lifecycle. Oversee SAPs, statistical analyses, QA/reviews, regulatory interactions, programming specifications, and timelines. Support complex projects, DSMBs, proposal work, and ensure inspection readiness while providing statistical programming and technical leadership.

Perform site qualification, initiation, monitoring (on-site and remote), management and close-out visits ensuring ICH-GCP/GPP and protocol compliance. Verify informed consent, source data vs CRF accuracy, IP handling, ISF/TMF reconciliation, and electronic data capture. Document findings, support recruitment/retention, train/mentor junior CRAs, contribute to audits, and support RWLP activities including chart abstraction and site identification. Travel up to 75%.