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Start-up Specialist II

Covance 10/11/2018 1:40:27 PM
JOB ID: 24144 Category: Study Start Up
Munich, Germany

   

 

Job Overview

Get ready to redefine what's possible and discover your extraordinary potential at Covance. Here, you'll have the opportunity to personally advance healthcare and make a difference in peoples' lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you'll be empowered to own your career journey with mentoring, training and personalized development planning.

Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow's drug development challenges, creating new possibilities for our clients—and your career.

COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. We have an exciting opportunity available to join our team.

We are currently recruiting Start-Up Specialist II to join our Sponsor's team
in Munich, Germany. This is a regular full-time position.

Duties and Responsibilities:

* Primary contact with more challenging sites or those hosting complex studies.
* The jobholder, working in a cross functional team, facilitates delivery of the site start-up (SSU) component of assigned studies within a country, including full accountability for delivery to time, cost and quality for assigned activities with minimal supervision.
* The jobholder operates within the boundaries of assigned budget, provides guidance to internal and site staff around process and other operational issues.
* Submits regular reports to Start-up Country Manager (SUCM) and project team regarding progress and challenges.
* Develops and implements strategies for the earliest possible approval of regulatory submission by reducing the hours allocated to activate sites, maximizing the time for patient enrolment and actively seeking local efficiencies within global processes.

Education / Qualifications

* University/College degree (life science preferred), or certification in a related allied health
profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology).

Mandatory:

* High proficiency with German language and English. Any other language is a plus.

Experience

* Minimum of 4 years of Experience in clinical development or regulatory process.
* Significant Experience of applying strong knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites.
* Significant Experience of issue escalation and resolution.
* Proven track record of effective communication and problem solving.
* Experience d in creating and maintaining good business relationships.
* Proven ability to work under pressure with multiple internal clients with competing goals.


Position Type: Full-Time

Location: Munich, DEU - Germany



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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).