Ogłoszenie, którego szukasz jest nieaktywne.

Administracja biurowa » Pracownik biurowy

  • Województwo zagranica
  • Miejscowość inne

Opis:

COVANCE BULGARIA - We are currently seeking a pro-active Start-Up Spec Nr ref.: /JOBS.pl COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner. We are currently seeking a pro-active GSS Specialist II to join our expanding CoSource team in Bulgaria. About the job: - Collect, review, process, and track regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, ICH GCP guidelines, EU Clinical Trial Directive, FDA Regulations and the Investigator Package Plan - Assist in review and approval of regulatory & investigator documents for study site activation and drug shipment trigger - Assist in preparation of project specific plans for the GSS component of assigned studies - Assist in review of core English patient informed consents for compliance to international requirements and protocol as applicable - Assist in reviewof core Country patient informed consents for compliance to country requirements and protocol as applicable - Assist in review of investigative site specific patient informed consents for required elements - Maintain and update document tracking information in the Trial TrackerTM Site Information Module and other tracking logs - Assess impact of site personnel changes on regulatory documents and process/review new documents according to GCP/ICH guidelines About you: - 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) - Good organizational and time management skills - Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project teams and investigative sites preferred - Good communication skills, oral and written - Self-motivation with the ability to work under pressure to meet deadlines - Works well independently as well as in a 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 - Computer proficiency (MS Office - Word, Excel, Power Point and Internet skills), aptitude for training, capable of operating standard office equipment (e.g. fax, copier etc.). More than 2 years of Experience in the field. THERE IS NO BETTER TIME TO JOIN US! Education/Qualifications Experience EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us. Sofia, BGR Sofia, Bulgaria Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

Ciekawe oferty z tego działu:
Przedstawiciel
Invest Finance jest firmą działającą w sektorze pożyczek krótkoterminowych. Wraz z rozwojem firmy poszukujemy do pracy przedstawiciela na region Trójmiasto i okolice. Do zadań kandydata...
Zobacz także >>
Porady ekspertów - zobacz artykuły

Proszę czekać - ładowanie treści...