Teams at Syneos Health

Conducts clinical site qualification, initiation, monitoring, management, and close-out activities for UK studies. Ensures ICH-GCP, regulatory, protocol, data integrity, informed consent, investigational product, and documentation compliance. Performs source data review, query resolution, site file reconciliation, recruitment support, audit readiness, and site communications. Manages site-level timelines and action plans, collaborates with sponsors and study teams, attends meetings and training, and may support real-world late-phase chart abstraction and junior staff training.

Conducts clinical trial site qualification, initiation, monitoring, management, and close-out activities. Ensures compliance with protocols, ICH-GCP, regulations, and SOPs; verifies informed consent, source documents, clinical data, investigational product handling, and essential files. Supports recruitment, query resolution, audit readiness, investigator meetings, and site communications while documenting activities and managing site-level timelines. Requires regular travel of up to 75%.

Leads biostatistical activities across clinical studies and programs, serving as the sponsor’s primary statistical contact. Develops and reviews SAPs, TLF specifications, analysis datasets, regulatory submissions, integrated analyses, and clinical study reports. Provides statistical design consultation, regulatory support, quality control, programming oversight, mentoring, DSMB/DMC participation, and cross-functional collaboration. Manages project timelines, supports labeling and benefit-risk analyses, and contributes to proposals and sponsor meetings.