Covance by Labcorp are seeking an accomplished Clinical Team Lead/Senior Clinical Team Lead with Medical Devices/In Vitro Diagnostics experience in the EMEA region.

This is the perfect opportunity for an experienced CTL with the right experience to develop their career in this field.

Flexible locations can be considered across EMEA (office or home based options). You will be managing clinical Diagnostic and/or Medical Devicestudies, andleading CRA activityacross multiple countries.

Primary duties:

• 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.
  
• Ability to function in the role as Clinical Operations Lead/Coordinating Lead or Project
  Responsible Person as required based on project set up.
  
• Provide guidance, mentoring and training for new hires and CTLs.
  

Join us and discover why Covance by Labcorp has been named by Forbes as one of the World's Best Employers 2020 and more than 90% of the top 20 global pharmaceutical companies are repeat customers. We can offer you not only a job, but a stable, long-term international career.

Remote, EMEA
Education/Qualifications:

• 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.

Experience:

• Strong, relevant clinical research experience, preferably in a CRO, with an ability to demonstrate comprehensive understanding of the Clinical Team Lead role on diagnostic studies.
• Thorough knowledge of ICH Guidelines and GCP, ISO 14155, the necessary safety reporting requirements for drugs and devices and a basic understanding ofregulatory requirements in other countries.
• Thorough understanding of the Diagnostic, Medical Device and Drug development process.

Preferred:

• Experience, or at least an understanding of ISO 13485
• Understanding the future impact of MDR / IVDR on device and diagnostic studies
• Experience in medical devices/in vitro diagnostics is essential.
• A good understanding of basic project management.

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