Senior Clinical Team Leader (Medical Devices and Diagnostics) role in the U.S.
Covance are looking for an accomplished / senior Clinical Team Leader with Medical Device or In Vitro Diagnostics experience.
This is a fantastic opportunity for an experienced CTL with the right experience to develop their career in this field.
Flexible locations can be considered across the United States (office or homebased options). You will be managing clinical Diagnostic and/or Medical Device studies, and leading CRA activity.
- Responsible and accountable for the management of the clinical study 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.
- Bachelor's Degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
- In lieu of the above requirement, candidates with strong relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
- Minimum requirement: 2 years' expereince as a CTL, or equivalent combination of education and expereince to successfully perform the key responsibilities of the job.
- Minimum 4+ years CRA expereince
- Strong relevant clinical research experience, preferably at a CRO, with an ability to demonstrate comprehensive understanding of the Clinical Team Lead role on device and or diagnostic studies
- Thorough knowledge of ICH Guidelines and GCP, ISO 14155, the necessary safety reporting requirements for drugs and devices and a basic understanding of regulatory requirements in other countries.
- Understanding of 21 CFR 812
- Thorough understanding of the Diagnostic, Medical Device and Drug development process.
- Understanding the future impact of MDR / IVDR on device and diagnostic studies
- Experience in the cardiovascular device, respiratory device or Neuromodulation areas as well as in vitro diagnostics would be an advantage.
- A good understanding of basic project management.
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