COVANCE BULGARIA - We are currently seeking a pro-active Start-Up Spec
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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
- 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!
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.