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Start Up Specialist

Covance - Budapest, Hungary

12/8/2017 5:57:40 PM
16294
Clinical Operations


Job Overview

Study Start Up Specialist oversees and manages the study start up phase of regional clinical trials. Responsibilities typically include contributing to the development and management of budgets, timelines and quality guidelines for projects, thereby ensuring that expectations are met while identifying and mitigating risks. The Start Up Specialist also compiles and drives documentation for the project, ensuring the accuracy and quality of regulatory data.

We are looking for a person with one - two years of Experience in real independent start - up activity who already has:

- set up contracts with Institutions, Investigators, Study coordinators, Vendors

- Experience in preparing documentation for Regulatory Authority/Central Ethics Committee submission – preparing and collecting applicable documents from investigational sites (CVs, GP certificates, protocol Signature Pages etc.), customized patient facing materials (Patient Information Sheet/Informed Consent Documents, Patient Alert Cards etc.) to fulfil local requirements

- already been involved in pushing investigational sites until internal regulatory greenlight is obtained (investigator start-up package approved)

Education / Qualifications

- University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
- Thorough understanding of the drug development process.

Experience

- Comprehensive understanding of applicable regional regulatory requirements.
- Ability to work with minimal supervision.
- Good planning and organization skills.
- Good computer skills with good working knowledge of a range of computer packages.
- Excellent verbal and written communication skills.
- Ability to lead and develop junior staff.
- Ability to understand and work with financial information.
- Ability to resolve project-related problems and prioritizes workload for self and team.
- Ability to work within a project team.
- Ability to work efficiently and effectively in a matrix environment.

Preferred:
- 1+ years additional Experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
- Local project coordination and/or project management Experience , especially regarding study start up.


Position Type: Full-Time

Location: Budapest, HUN - Hungary






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