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Clinical Team Lead, Medical Devices and Diagnistics

Covance 3/28/2019 1:19:12 PM
JOB ID: 28568 Category: Clinical Team Lead
Maidenhead, United Kingdom

   

 

Job Overview

Clinical Team Leader, (Medical Device and Diagnostics) role in EMEA region.

Covance are looking for an Experience d Clinical Team Leader to work in our Medical Device / Diagnistics Division. This is a fantastic opportuntiy for an Experience d CTL with Medical Devices and /or 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 medical device studies, and leading CRA activity across multiple countries. Previous Experience in a similar role is essential.

Primary duties:

* Responsible and accountable for the management of the Medical Device 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.

Education / Qualifications

* BSc or equivalent 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

Experience

* Strong Experience as a CTL essential, working in Medical Device and or Diagnostics studies.
* You will have Experience overseeing clinical aspects of a study across multiple countries and leading CRAs.
* Previous CRA Experience required,
* Laboratory Experience would be desirable
* Working knowledge of ICH-GCP and ISO14155


Position Type: Full-Time

Location: Maidenhead, UK - United Kingdom



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Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit www.gettinghired.com or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).