Jobs at Syneos Health

Designs, analyzes, and interprets real-world evidence studies using EMR and claims data. Develops protocols, data specifications, statistical analysis plans, cohort definitions, causal inference methods, trial emulations, external control arms, and sample size calculations. Collaborates with HEOR, market access, regulatory, and clinical development teams, translating findings into reports and presentations. Requires strong RWE, observational study, healthcare coding, statistical programming, SQL, OMOP, and RWE CMH expertise.

Supports country-level clinical trial site activation, including regulatory and ethics submissions, essential document collection, milestone tracking, financial monitoring, TMF filing, site feasibility, investigator contract and budget support, CTA execution, and coordination among sites, sponsors, and functional teams.

Reviews and evaluates clinical trial data within oncology studies, supporting data quality, consistency, and drug development objectives. Collaborates with clinical solutions and study teams to identify issues, apply therapeutic expertise, and help deliver reliable outcomes for life sciences customers.

Manage regulatory submission planning, tracking, content plans, timelines, and communications using Veeva Vault RIM and related publishing tools. Translate Smartsheet timelines into Microsoft Project and coordinate submission activities with global submission managers and publishing teams. Apply knowledge of FDA, EMA, and ICH requirements, including eCTD, NDA, IND, EU CTA, MAA, EU CTR, and NDS submissions. The role requires strong organization, communication, attention to detail, and the ability to meet firm deadlines.

Lead and coordinate regulatory strategy and submissions across Latin American markets. Track health authority requests and regulatory changes, provide regional regulatory expertise, prepare submission timelines and responses, maintain Veeva submission records, and advise cross-functional teams on local labeling, CTD, GMP, and other regulatory requirements. Facilitate collaboration with international regulatory teams, internal departments, authorities, and external submission partners while ensuring compliance with company policies.

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.

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.

Conduct real-world data analyses using SAS or R and commercial claims and EHR databases. Build longitudinal study cohorts, define baseline and outcome variables, apply epidemiologic methods, perform statistical tests, regression and survival analyses, assess data quality, review protocols and statistical analysis plans, and program tables, figures, and listings. The role requires advanced biostatistics or epidemiology expertise and strong communication skills.

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%.

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

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 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.