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AM Clin Ops

Covance 3/20/2019 3:07:14 PM
JOB ID: 29466 Category: Clinical Operations Management
Vienna, Austria

   

 

Job Overview

An amazing opportunity for a budding or Experience d CRA Line Manager has emerged at Covance - based in AUSTRIA. This is a HOME BASED position.

The successful candidate would be assigned a number of direct reports (comprising mainly of home based CRAs) and would be responsible for the performance management for these reports - all of whom are working for Covance but 100% outsourced to a world class leading pharmaceutical company.

You would be responsible for supervision, performance review, management, development plans, annual reviews, training and performance issue management.

You would also play a vital role in relationship management with our Client (the top pharma company) in terms of resource management and identification and selection of new recruits. The team is growing in Austria and also in Switzerland so you would potentially have exposure to managing CRAs in both countries.

Overall your remit would be to ensure high standards of monitoring within the team acording to ICH GCP. Outline below:-

* Has GCP oversight of direct reports by ensuring GCP training is executed, understood and implemented
* Identify and escalate GCP issues identified through regular interactions with direct reports and conduct of Quality Control Visits
* Ensures training record compliance with training matrix and ensures training records are up to date
* Provide input to relevant SOPs and standard plans/templates for use by Project Management and Clinical Operations staff
* Assist with on-boarding of new direct reports ensuring GCP training before monitoring begins
* Hold Clinical Operations and CoSource staff accountable for GCP issue escalation to the management team, the sponsor and QA, as appropriate
* Hold Clinical Operations staff accountable for quality and compliance with project plan and adherence to contract obligations in Source Data Verification, Monitoring Visit cycles, Trip Report quality and on time deliverables
* Hold CoSource staff accountable for quality and compliance with client SOPs and adherence to Source Data Verification, Monitoring Visit cycles, Trip Report quality and on time deliverables
* Coach assigned staff to own effective Investigator relations and Investigator oversight at the local level

A full job description is available. Please contact Marc Joseph on 0044 1753 216664 or email marc.joseph@covance.com

key words line manager, line management, Austria, monitoring, clinical research associate, CRA, senior clinical monitor, man management

Education / Qualifications

* University/college degree — life sciences preferred or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
* In lieu of this required educational background the following relevant work history may be considered:
* Minimum of two (2) years supervisory Experience in a health care or clinical research setting and
* Minimum of six (6) years relevant clinical research Experience in a pharmaceutical company/CRO

Preferred:

* Masters or other advanced degree

Experience

The successful candidate will be an Experience d clinical site manager/monitor - encompassing site selection, initiation, monitoring and close out visits. We would ideally like to see at least 4 years of Experience in this respect. Thourough knowledge of the drug development process. Some Experience as a line manager or project manager is preferred. Excellent interpersonal skills.


Position Type: Full-Time

Location: Vienna, AUT - Austria



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

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