Teams at Syneos Health

Perform site qualification, initiation, monitoring, management and close-out visits (on-site or remote) ensuring ICH-GCP and protocol compliance. Verify informed consent, source documents, CRF accuracy, IP handling, ISF/TMF reconciliation, and EDC compliance. Document findings, support query resolution, site training, audit readiness, and collaborate with project teams, sponsors and local staff. May perform chart abstraction and real-world late phase site support.

Oversee site management, clinical and central monitoring, and related deliverables to ensure patient safety, GCP/regulatory compliance, and data integrity. Coordinate cross-functional handoffs, manage CRAs/central monitors, identify and mitigate risks, maintain CTMS/clinical tools, review monitoring documentation, and provide status updates to sponsors and project teams. Support training, inspection readiness, and delivery of study milestones including enrollment and database lock.

Prepare and submit IND, marketing and lifecycle maintenance applications (especially CMC) for EU, APAC and Gulf regions; perform high-quality information processing and regulatory database maintenance; conduct QC reviews and track submissions; support project delivery, risk identification and escalation; review and mentor junior staff; attend client meetings and maintain required training records.