The Clinical Trial Manager II (CTMII) is responsible for the operational management and oversight of the clinical investigative sites as well as the clinical operations deliverables of clinical trials. This includes but is not limited to training and study level oversight of clinical research associate (CRA) activities, identifying and managing quality issues related to site performance and monitoring, ensuring adherence to study plans, developing action plans to address concerns, as well as ensuring timelines are met and study is conducted according to budgets.
The Clinical Trial Manager II :
- Ensures all clinical monitoring activities are performed in accordance with the Sponsor’s contract.
- Ensures timely, quality deliverables in accordance with applicable standard operating procedures (SOPs), ICH/GCP guidelines, regulations, laws, and study-specific requirements.
- Identifies quality issues and trends in site performance through KPI reviews, project meetings, site communications, and audit findings.



Summarizes findings and establishes action plans to bring corrective actions forward to study team and sponsor, as applicable.
- Maintains an in-depth knowledge of the protocol, therapeutic area and indication.
- Serves as primary sponsor contact for operational site-specific issues and clinical deliverables;
- Contributes to internal, sponsor, and investigator meetings.
- Manages risk assessment and execution of mitigation.
- Serves contact for sponsor and project team for all clinical operations matters and clinical deliverables.
- Provides training/mentoring and oversight the CRAs, Lead CRAs, and other clinical operations staff, as applicable, Including overseeing the transition of CRAs.
- Accountable for site management activities, including (but not limited to) maintaining site contact lists, coordinating site training, and monitoring site performance).
- Manages site screening and enrollment oversight.
- Tracks site visit report metrics to ensure quality, com

📌 Clinical Trial Manager II (Madrid)
🏢 Indero
📍 Madrid