Clinical Team Lead (Diagnostics and Medical Devices)

Maidenhead, United Kingdom
06 Sep 2019
06 Oct 2019
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Clinical Team Leader (Diagnostics and Medical Devices)role in EMEA region.

Covance are looking for an experienced Clinical Team Leader withIn Vitro Diagnostics experienceto work in our Medical Device / DiagnosticsDivision. This is a fantastic opportunity for an experienced CTL with Diagnotics experience to develop their career in this field.

Flexible locations can be considered across EMEA (office or homebased options). You will be managing clinical Diagnosticand/or Medical Devicestudies, andleading CRA activityacross multiple countries. Previous experience inDiagnostics orsimilar role isessential.

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.
  • Bachelor\u2019s 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.
  • Thorough knowledge of ICH Guidelines and GCP including a basic understanding ofregulatory requirements in other countries.
  • Thorough understanding of theDiagnostic, Medical Device andDrug development process.


  • Experienced Lead diagnisotics Diagnistics experience essential
  • Strong relevant clinical research experience, preferably at a CRO, with an ability to demonstrate comprehensive understanding of: ICH/GCP guidelines, Serious Adverse Event (SAE) reporting
  • Experience as a Senior Clinical Research Associate with on-site monitoring experience, whether internal or external.

  • Experience in the following diagnisticsareas would be an advantage:Infectious disease (Influenza, Sepsis); Oncology diagnosticsand Diabetes/glucose monitoring.
  • Additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
  • Local project coordination and/or project management experience.

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