17 oct
|
Premier Research
|
Castilla-La Mancha
17 oct
Premier Research
Castilla-La Mancha
Overview As Clinical Lead II, you drive site management, quality oversight, and monitoring performance to advance life-changing therapies. You will partner with sponsors and cross-functional teams to deliver clinical deliverables, ensure audit readiness, and optimize monitoring quality. You’ll work within the Clinical Management team to support Rare Diseases and Oncology programs, including pediatric trials and advanced therapies. This role offers impact across general trials and a clear path for professional growth in a purpose-driven environment. Responsabilidades * Serve as the initial point of contact for site management and monitoring quality concerns, initiating sPIP if needed * Plan, present, and participate in sponsor calls, delivering status updates on clinical deliverables * Oversee quality of monitoring and site management through dashboards and reporting tools; contribute to the central monitoring plan * Monitor clinical operations metrics, data entry timelines, protocol deviations,
and backlog items; track turnaround times * Maintain audit readiness for Premier and sites; respond to audit findings and support remediation * Escalate performance concerns and significant events through established channels (CRA/CM/SSU) * Assist in budget understanding, pass-throughs, and resource management Requisitos principales * Bachelor’s degree in clinical, biological, scientific, or health-related field; or equivalent work experience * At least 2 years as a Clinical Lead in a CRO setting with onsite monitoring experience * Experience in Rare Diseases and Oncology; ideally gained as a Clinical Lead rather than CRA * Experience with pediatric trials; familiarity with CAR-T or Cell Gene Therapy is a plus * Knowledge of clinical financials including budgets, pass-throughs, and resource management * Strong communication and presentation skills * Cross-functional collaboration * Proactive problem solving and escalation * Onsite monitoring and risk-based monitoring (RBM) * C
📌 Clinical Lead II (Castilla-La Mancha)
🏢 Premier Research
📍 Castilla-La Mancha