Global Site Service Specialist
募集要項
| 年収 | 600万～1000万 |
|---|---|
| 雇用形態 | 正社員 |
| 職種 | 前臨床研究(薬物動態) |
| 仕事内容 | Develop project specific plans for the Global Site Service （GSS） component of assigned studies • Liaise with operational project team regarding project issues （i.e., participate in team meetings） • Collect, review, approve process and track regulatory ＆ investigator documents required for study site activation in accordance with our SOPs, sponsor SOPs, GCP ICH guidelines and the Investigator Package Plan • Review and approve core English patient informed consents for compliance to international requirements and protocol as applicable • Review and approve core Country patient informed consents for compliance to country requirements and protocol as applicable • Review and approve investigative site specific patient informed consents for required elements • Resolve informed consent and contractual language issues by exercising advanced judgment when interacting with study sites • Negotiate contracts and budgets with investigative sites within parameters provided by Sponsor • Liai |
| 求める人材 | 【求める条件】 • 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 and time management skills • Excellent communication / writing skills • Strong computer skills with an ability to access and leverage technology alternatives • Abilities to review/analyze relevant data so as to assist in building evidence－based clinical trial strategies • 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 • Multi－tasking capability • Ability to work independently |
会社情報
| 会社名 | 会社名は非公開です |
|---|---|
| 業種 | 食品 |
| 資本金 | 251億2200万円 |
| 従業員数 | - |
