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Global Site-Start Up Specialist in Multinational CRO Company(MNCs)
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[Company Status]
This company 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 lifesaving and lifeenhancing medicines to people around the world. Our commitment to this mission has resulted in MNC’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. About the Job
[Job Position]]
Global Site-Start Up Specialist
Exciting and rewarding career opportunity with one the world's largest, fastest growing, most well known Contract Research Organizations (CROs). MNCs is growing in Asia Pacific and we are looking for talented individuals like you to fuel our growth plans for the future.
This is a chance for you to be at the forefront of helping to bring the miracles of modern medicine that help improve the quality of and save lives for countless individuals across the globe.
We offer competitive pay, outstanding benefits packages that are available to you immediately upon hire, as well as ongoing training and individual development programs, as well as the finest career advancement opportunities in the industry.
Join our growing team in the Global Site Services Department Positions Available Include Global Site Services Associate and Global Site Services Specialist
[Responsibilities]
- Delivery of the Global Site Services (GSS) component of assigned studies within a country or globally. Including accountability for delivery to time, cost and quality for assigned activities
- Primary contact with investigative sites during site start-up activities.
- Responsible for working with investigative sites to collect the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP, FDA regulations (for IND studies) and/or the study sponsor.
- Responsible for maintenance of site address and personnel information in the study database as well as maintenance of regulatory documents throughout the duration of the clinical trial.
- Work with staff in Operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials.
- Where applicable, provide logistical support of clinical trial supply coordination.
- Directly manage day to day conduct with clients for stand alone feasibility activities and other feasibility activities as appropriate.
- Monitor performance of GSS team with regard to project timelines and mentor them accordingly
[Requirements]
- 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) AND 3 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.
- In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 5 years work experience in clinical research will be considered.
- Those with 6 years clinical research experience with leadership abilities shall be considered for GSS II position.
- 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.
- Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe.
- Good organizational, verbal and written communications, and time management skills
- Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies
-Self-motivation, multi-tasking capability with the ability to work under pressure to meet deadlines
- Works well independently as well as in a team environment
[Location] Seoul, Korea
[Salary]
- negotiation
- Full time job
[Number of Persons (Gender)] 1, No Gender preference
[Apply a Position]
Please send your English resume (Documents/ CVs must be written in English)A.S.A.P (MS word only)by E-mail top@topheadhunter.co.kr
* The title of E-mail should be Global Site-Start Up Specialist in Multinational CRO Company(MNCs)
* All submitted documents will be treated with highly confidential manner.
Thank you for your interest.
[Contact]
Tel No 82-2-555-7234
E-mail top@topheadhunter.co.kr
* 지원하시는 인재에게는 헤드헌팅 추천 서비스가 무료로 제공 되는 것으로서 어떠한 경우라도 비용이나 수수료를 받지 않고 100% 무료로 서비스를 제공하고 있습니다.
* 당사는 14년 된 국내 최고의 헤드헌팅 전문 기업으로서 진행 중 또는 프로젝트 종료 후에도 개인들이 지원한 사항이나 개인정보에 대해서는 철저한 보안이 유지되니 안심하시고 지원하셔도 됩니다
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Global Site-Start Up Specialist in Multin...
