Clinical Science

【求人No NJB2292550】
日本における臨床開発の専門家として、臨床試験や承認後調査の全工程をリード・支援します。試験計画、データ解析、報告書作成、規制対応、品質管理、関係者との連携を担当し、チームの育成やトレーニングも行います。安全性報告や監査準備にも関与し、プロセス改善や業界動向の把握を通じて臨床開発の質向上に貢献します。

■Education
・ Relevant degree in life sciences/healthcare （or clinically relevant・degree） is required

■Experience/Professional・requirement
:・ ・ 5 years of involvement in clinical research or drug
development in an academic or industry environment spanning
clinical activities in Phases I through IV and PMS. ・ 5 years of
contribution and accomplishment in all aspects of conducting
clinical trials or PMS （e.g. planning executing reporting and
publishing） in a global/matrix environment in pharmaceutical
industry.
・・ Advanced knowledge of assigned therapeutic area
・ Demonstrated ability to establish strong scientific partnershipwith key internal and external stakeholders
・ Thorough knowledge of ICH GCP and GPSP clinical trial/PMSdesign and methodology statistical analysis methodology andregulatory/ clinical development process・ 2 years peoplecoaching/supporting experience required this may includemanagement in a matrix environment.・
・ Demonstrated leadership and team management skills.・ Excellent communication skills written and oral
・ Strong interpersonal skills
・ Excellent negotiation and conflict resolution skills

■English Skill:
・ Capable oral and written English