Jobs at Syneos Health

Process and enter ICSRs into safety databases, triage and code events and medical history, perform literature screening, MedDRA coding, xEVMPD submissions, duplicate identification, quality review, and ensure compliance with SOPs, GCP, GVP and regulatory reporting requirements. Support TMF submissions, audits, and cross-team collaboration.

Perform on-site and remote monitoring of clinical trials to ensure GCP and regulatory compliance; develop monitoring tools and SOPs; coordinate site visits and track study progress; document findings and write monitoring reports; collaborate with investigators, site staff and cross-functional teams to support study conduct.

Lead global compensation systems, salary structure governance, market pricing, pay equity and regulatory compliance. Build compensation models and executive reporting, manage a small global analytics team, and establish process governance to support total rewards strategy.

Lead and support global site contract and budget negotiations for clinical studies. Act as subject matter expert, develop training, manage escalations, advise sponsors/study teams on CTA strategy, maintain status reporting, collaborate with legal/finance/operations, mentor staff, and drive contract execution to meet study start-up timelines. Minimal travel (up to 25%).

Perform site qualification, initiation, monitoring, management and close-out visits to ensure ICH-GCP and protocol compliance. Review informed consent, source documents and CRFs; resolve queries; verify investigational product handling; reconcile ISF with TMF; document monitoring activities; support recruitment, audit readiness and sponsor communications. For late-phase real-world studies, support chart abstraction and collaborate with affiliates and local staff.

Support pharmacovigilance operations by triaging and entering ICSRs, coding events and medications, performing MedDRA coding and literature screening, managing duplicates, assisting expedited reporting and xEVMPD submissions, maintaining safety tracking and compliance with GCP/ICH/GVP, and ensuring documentation in TMF and PV systems.

Process and triage ICSRs: data entry, coding, narrative summaries, query resolution, expedited reporting, literature review, MedDRA coding, xEVMPD/SPOR/IDMP tasks, duplicate management, quality review, TMF submissions, and ensure compliance with SOPs, GCP, GVP and regulatory requirements.

Perform project-level financial analysis and reporting for business units: record revenue, load and maintain budgets in Oracle/Revenue Wizard, analyze variances, support forecasting/backlog, prepare project closeouts, run P&L and G/L reports, attend project meetings, and produce ad-hoc reports. Monitor project health (revenue, gross profit, receivables, unbilled) and support Business Unit Controller and project managers. Minimal travel (up to 25%).

Process and track individual case safety reports (ICSRs), enter and code safety data, perform literature screening, validate/submission of regulatory product records, manage duplicates and quality review, maintain safety tracking and regulatory compliance (ICH GCP, GVP), submit documentation to TMF, and support audits and safety reporting activities.

Process and enter ICSRs into safety databases, triage and code events and medications, perform MedDRA coding and literature screening, manage duplicates and xEVMPD/SPOR/IDMP records, maintain safety tracking and TMF submissions, support quality review and regulatory reporting according to SOPs and GVP/ICH GCP.

Process and quality-review individual case safety reports (ICSRs): triage, data entry, coding (MedDRA), narrative compilation, duplicate identification, literature screening, xEVMPD/SPOR/IDMP activities, and ensure regulatory-compliant safety reporting and documentation.

Lead project-level non-CRF data management: define non-CRF data types, coordinate vendors and transfers, implement IXRS UAT, manage DTS/DTA/FFS and testing, ensure data delivery, oversee TMF and financials, report to sponsors, mentor staff, and maintain SOP compliance.

Perform SAS programming for clinical study data standards (SDTM, ADaM) and create TFLs for safety and efficacy. Support PK/PD analyses, handle ad-hoc requests, and contribute to macros, ISS/ISE and oncology analyses as needed.

Monitor and manage clinical study sites through qualification, initiation, interim monitoring, and close-out. Ensure ICH/GCP and protocol compliance, verify informed consent and CRF accuracy, perform source document review, IP oversight, ISF/TMF reconciliation, document site activities, support recruitment/retention, and prepare sites for audits. May perform chart abstraction and collaborate with sponsors and local staff; may train junior staff.

Performs site qualification, initiation, monitoring, management and close-out visits to ensure regulatory and protocol compliance. Reviews source documents, verifies CRF/EDC data, supports IP handling, maintains ISF/TMF accuracy, documents activities, and supports recruitment and audit readiness. May train junior staff and collaborate with sponsors and local affiliates on real-world late-phase studies.

The Clin Ops Specialist ensures compliance in clinical trials, manages communications with participants, and supports study processes with administrative tasks.

Join Syneos Health as a Project Associate to support clinical, medical affairs, and commercial initiatives within an integrated biopharmaceutical environment.

Responsible for providing quality deliverables at the country level for regulatory submissions, tracking milestones, and ensuring compliance with project timelines. Prepares various regulatory applications and may negotiate contracts and budgets.

The role involves supporting clinical operations by managing site communications, maintaining trial documentation, tracking clinical data, and coordinating logistics for clinical studies.

Perform site qualification, monitoring, management, and close-out visits while ensuring regulatory compliance and data integrity. Support subject recruitment and project objectives.