Clinical Team Leader role in EMEA region. Flexible locations can be considered across EMEA (office or homebased options).
We are looking for a Clinical Team Lead (CTL) with experience in this role to manage clinical studies, and lead CRA activity across multiple countries. Previous experience in a dedicated lead role is essential.
+ Responsible and accountable for the management of the Clinical Operations team with particular emphasis on teamwork, quality, timelines, budget, metrics and compliance with the project plans and SOPs.
+ Develop the strategy, plans, tools and training to oversee and assess performance of the clinical team, in the conduct and compliance of site visits (on site and remote), including, but not limited to: Pre-Study Visits, Site Initiation Visits, Routine Monitoring Visit, Motivational Visits, Close-out Visits, Audit support Visits.
+ Proactively communicate with CRAs and other members of the clinical operations team to follow up on all open issues, drive patient recruitment and retention, in order to meet the project timelines.
+ Ensure that all study related, clinical related documents are tracked, filed and reviewed (QC check) and complete according to the SOPs, regulatory requirements and protocol.
+ Responsible and accountable for understanding and managing the clinical operations budget for the project, and ensure that the activities are within budget and scope of work, and to discuss with the project team to support financial progress, and team utilization.
+ Communicate effectively with all members of the project team and client as applicable, to support the study completion per company and client requirements and timelines, including risk identification and mitigation, issue escalation and working with Quality and the project team on Corrective and Preventative Actions.
+ As required by the project roles participate and oversee the site selection process. Depending on the scope and roles within the project team, this may be performed in collaboration with other team members.
+ As required by the project roles participate and oversee the regulatory/ethics committee submissions, tracking and documentation.
+ Support new business with active participation in Bid Defense preparation and meetings, as required.
+ Perform other duties as required by the Department or Project Team.
+ The CTL role is responsible for management of the clinical operations portion of the project budget. The amount is project dependent.
+ BSc or BA degree in a biomedical or related life science, or nursing qualification.
+ Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
+ Climical lead experience essential, overseeing clinical aspects of studies across multiple countries and leading CRAs.
+ Previous CRA experience required.
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.