Regulatory Submissions Coordinator
Quality check on submission documents and site essential documents;
Interaction with US Central IRBs, sites and international associates;
Preparation and approval of informed consent forms; and
Review pertinent regulations to develop proactive solutions to start-up issues and challenges.
A Bachelor's degree in a relevant field and at least 0.5 year of pharmaceutical research experience, or Master's degree within Life Sciences;
1 - 3 years of work experience in a clinical trial environment;
Knowledge of local regulations regarding clinical studies and the conduct of such studies;
Strong oral and written communication skills;
Excellent computer skills, including a working knowledge of Microsoft Office applications.
Bilingual Japanese and English
|450万 〜 600万円
Provide oversight of preferred site relationships within assigned countries; Provide ongoing support of sites, including identifying and discussing future new business opportunities and feasibility assessments; Develop effective plans for site contact and follow-up; Serve as main point of contact for project teams regarding site performance issues and updates on pertinent site information; Support management in expediting feasibility, site selection and study start-up;
Responsible for managing contract & budget negotiations for assigned projects; Play a key role in managing timelines; Responsible for reporting contract & budget negotiation progress to internal and external project teams; and Serve as primary point of contact for internal and external project teams.
Serve as a liaison between Sponsor, investigative sites and Company; Negotiate contracts and budgets with investigative sites; and Collaborate with internal project team to ensure negotiations occur within timelines.
【職務内容】 ・治験(Phase1-4)実施施設との契約交渉と契約書のレビュー ・治験契約プロセスに関与するベンダー(CRO, SMO 等)のマネジメント ・各治験の予算、契約書およびその他文書を含めた治験契約に関する準備、交渉、実行、締結