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Associate Local Start Up Manager, Ukraine

Covance 9/19/2018 7:12:21 PM
JOB ID: 23402 Category: Hidden 23502
Kiev, Ukraine

   

 

Job Overview

At Covance, you'll redefine what's possible and discover your extraordinary potential. You'll have the opportunity to personally advance scientific research and make a difference in peoples' lives with your bold ideas and unique point of view. We are looking for a Local Study Start Up Manager to be office based in Kiev and working for one of our clients.

Responsibilities:

* 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
* 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
* Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments
* Contributes to the development of local SOPs
* Works in close collaboration internally with Clinical country operations (CRD, CRM,CTC,CRA), Country Quality Manager (CQM), Finance, Medical Affairs, Regulatory Affairs, PharmacoVigilance, Business Compliance, Legal and regional operations, Head Quarter functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones
* Collaborates closely with Regional Operations to align country timelines for assigned protocols
* Provides support and oversight to local vendors as applicable
* Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management
* Enters and updates country information in clinical, regulatory, safety and finance systems.

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
* In lieu of the above requirement, candidates with minimum of four (4) or more years of relevant clinical research Experience in pharmaceutical or CRO industries or Experience in a health care setting will be considered
* Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
* Thorough understanding of the drug development process
* Fluent in local office language and in English, both written and verbal

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
* Minimum of four-six (4-6) years of clinical research Experience


Position Type: Full-Time

Location: Kiev, UKR - Ukraine



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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).