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Associate Start-up Project Manager

Covance 2/22/2019 2:02:11 PM
JOB ID: 28269 Category: Clinical Operations Entry Level
Budapest, Hungary

   

 

Job Overview

Discover new opportunities to grow your career as a Covance FSP Associate Start-Up Project Manager.

Are you someone with previous regulatory submissions Experience looking for developing your career within this area?

At Covance we are recruiting for a Start-Up Associate Project Manager to work sponsor dedicated into a top 5 pharmaceutical company to be based in Hungary, Budapest.

At Covance, you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP).

As a Covance employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Covance has an FSP opportunity to match your area of expertise.

Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Covance studies.

With the support of exceptional people and an energized purpose, you'll be empowered to own your career journey with dedicated mentoring, training and personalized development planning.

Responsibilities:

FINANCIAL (as applicable):

* Assistance with the ownership of country and site budgets.
* Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
* Oversight and tracking of clinical research-related payments
* Payment reconciliation at study close-out.

COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS (as applicable):

* Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
* Development of local language materials including local language Informed Consents and translations.
* Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.

MANAGEMENT & QUALITY OVERSIGHT:

* Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments.
* Contributes to the development of local SOPs.

Education / Qualifications

* University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology

Experience

* Good organizational and time management skills
* Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.
* Excellent communication skills, oral and written.
* Self-motivation with the ability to work under pressure to meet deadlines
* Works well independently as well as in team environment.
* Detail and process oriented
* Positive attitude and approach
* Interact with internal and external customers with high degree of professionalism and discretion
* Multi-tasking capability.
* Good computer skills with good working knowledge of a range of computer packages
* Ability to lead and develop junior staff
* Flexible and adaptable to a developing work environment


Position Type: Full-Time

Location: Budapest, HUN - Hungary



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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).