Site Relationships Coordinator
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;
Bachelor's degree and at least 2 years of Clinical Monitoring experience;
Knowledge of drug development, clinical trial management and operational procedures, including GCP guidelines;
Demonstrated ability to effectively communicate with internal and external parties, including Principal Investigators and consultants;
Possess a thorough understanding of feasibility assessments, strategies, approaches and requirements in order to facilitate these processes;
Demonstrated ability to manage complex/high priority site relationship tasks, including relations with partner sites
Demonstrated organizational and prioritization skills;
Demonstrated oral and written communication skills;
Proficient knowledge of Microsoft Office applications.
Bilingual Japanese and English
|年収||500万 〜 780万円|
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.
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