Jobs at Syneos Health

Lead and deliver operational and financial management of complex global clinical projects from proposal through closeout. Serve as primary client liaison, manage cross-functional teams, ensure GCP and regulatory compliance, maintain project tracking and inspection readiness, oversee budgets and deliverables, mentor/line-manage junior PMs, support business development, and implement risk mitigation and resource strategies. Travel ~25%.

Manage and coordinate clinical study deliverables, maintain TMF and inspection readiness, assist with interim analyses, vendor selection and management, financial reporting and budget reconciliation, facilitate team training, and support client communications and proposal activities to help meet study milestones.

The Clinical Trial Manager II oversees clinical trials, ensuring compliance with regulations, managing site interactions, and coordinating teams to meet project milestones.

Design and analyze real-world evidence studies using EMR and claims data. Develop SAPs/protocols, apply causal inference and trial-emulation methods, construct external control arms, perform sample size and power calculations, write cohort definitions in SQL, and translate results for HEOR, regulatory, and clinical stakeholders.

Provide TMF management and clinical document coordination using Veeva Vault, support study startup and site activation, track timelines/KPIs, prepare meeting materials and reports, ensure GCP and audit readiness, and act as escalation point and mentor within sponsor-dedicated, remote clinical trial teams.

Manage negotiation, execution, and financial oversight of clinical trial agreements and budgets for sponsor-dedicated studies. Serve as liaison across Clinical Operations, Finance, Legal, Procurement, vendors and sites; use Veeva and grant tracking systems to manage payments, forecasting, documentation, compliance with ICH-GCP and Health Canada, and support multi-country contracting and process improvements.

Perform site qualification, initiation, monitoring, management and close-out visits (on-site or remote) ensuring ICH-GCP/GPP and protocol compliance. Verify informed consent, perform source document review and CRF verification, manage investigational product inventory, reconcile ISF with TMF, document monitoring activities, support recruitment and audit readiness, liaise with sponsor and site staff, and may mentor junior CRAs or support RW late-phase activities.

Lead statistical programmer developing SAS code and ADaM-specified datasets, tables, listings, and graphs for clinical trials. Ensures quality, validation, documentation, inspection readiness, mentors programmers, manages timelines, participates in sponsor meetings, and follows regulatory and SOP requirements.

Lead accounting functions including SR&ED claims, income/indirect/transaction tax audits, SOX controls, month/quarter/year-end close, GL reconciliations, tax filings (GST/QST), Oracle Fusion ledger support, and audit/statutory deliverables while collaborating with international teams.

Perform site qualification, initiation, monitoring (on-site or remote) and close-out to ensure ICH-GCP/GPP and protocol compliance. Verify informed consent, source documents, CRF data, IP handling, ISF/TMF reconciliation, and query resolution. Document activities, support recruitment/retention, prepare for audits, train/mentor junior CRAs, and manage site communications and timelines. May support Real-World Late Phase tasks including chart abstraction and country-level regulatory coordination.

Conduct site qualification, initiation, monitoring, management, and close-out visits to ensure protocol, regulatory and ICH/GCP compliance. Review source documents and CRFs, manage queries, investigational product handling, ISF/TMF reconciliation, documentation, and support audit readiness. Act as liaison with sites and sponsors, support recruitment/retention, and may train junior staff. Heavy travel (up to 75%).

The Director of Epidemiology Pipeline collaborates on virology clinical trials, providing scientific expertise, leading project proposals, and overseeing study management and regulatory compliance.

The Principal Biostatistician leads biomarker analysis for clinical studies, develops evaluation plans, conducts data analyses, mentors staff, and ensures accurate statistical deliverables while collaborating across teams.

Support sponsor-dedicated clinical studies across Canada by preparing Health Canada and REB/IRB submissions, maintaining regulatory files and CTSI documentation, tracking milestones, processing invoices, supporting start-up/closeout, and managing 15+ concurrent protocols while ensuring compliance and inspection readiness.

Oversee clinical trial operations focusing on patient safety, data integrity, and compliance while leading site management and team collaboration.

The role involves programming and data review for real-world data analysis, supporting epidemiologists, and managing complex data sets using statistical programming languages and tools.