12 ago
|
Evestia Clinical
|
Madrid
12 ago
Evestia Clinical
Madrid
About The Role We are looking for an experienced Clinical Team Lead to drive the successful delivery of clinical studies, support and mentor clinical operations team members, and ensure the integrity, quality and compliance of clinical trial activities from start‐up through to close‐out.
Job Responsibilities Participate in all aspects of a clinical trial from development and planning to study closure.
Demonstrate the ability to lead in a team environment and mentor CRAs.
Execute the Clinical Monitoring Plan (CMP) in consultation with the project team and the client.
Comply with applicable regulations, ICH/GCP and Evestia Clinical and/or sponsor SOPs to assess the safety and efficacy of investigational products (drugs, biologics or medical devices).
Ensure that assigned sites are in compliance with the study protocol, metrics, and will within project teams under supervision, reporting to a project manager.
Responsible for ongoing analysis of enrolment activities/trends and escalation/mitigation to PM/Sponsor as appropriate.
Works with PM to develop strategic and tactical plans for ensuring enrolment targets are met.
Oversee clinical portion of the Trial Master File (TMF) and conduct periodic review for completeness.
Conduct internal team calls and Sponsor calls (as needed).
Perform site qualification, initiation, interim monitoring, and close‐out visits ensuring regulatory and protocol compliance; any visits may be performed on‐site or remotely.
Must be an effective liaison between sponsors, investigators and Evestia Clinical.
May travel for client meetings, investigator meetings, co‐monitoring visits, quality oversight visits, and perform other tasks based on business needs.
Qualifications Undergraduate degree or equivalent combination of education, training and experience.
Significant experience in clinical research and on‐site monitoring, with the expertise to lead clinical activities, support study delivery and mentor team members.
Exemplary clinical monitoring,
📌 Clinical Team Lead (Madrid)
🏢 Evestia Clinical
📍 Madrid