【東京都　外資系CRO臨床開発】

一般内科、神経内科、精神科、その他（免疫内科・感染症内科）、製薬会社

その他
"Project Related Medical/Safety Support:
◇Minimize potential risk to 〇〇 and clients by managing medical aspects of contracted tasks. This includes, but is not limited to, medical monitoring of all safety variables (AE, laboratory abnormalities, changes in patient medical status as well as inclusion/exclusion criteria, evaluation prescribed concomitant medication for protocol restrictions and unblinding requests). Scope of work also includes discussion internally with medical monitors in Japan, APAC and global and project team colleagues internally, as well as with principal investigators and clients of all medical issues during the course of a study by proper medical judgment, interpretation and decision.
◇Medical review of serious adverse events.
◇Ensure tasks delegated to medical monitors are properly executed. Adhere to applicable regulations and ICH guidances regarding clinical trials, regulatory documents, and safety issues. Adhere to client SOPs/directives and project specific WPDs for assigned projects. Adhere to 〇〇’s corporate policies and SOPs/WPDs.
◇Present 〇〇 standard medical processes to clients at business development meetings, investigator meetings, and communicate with various medical communities to explore and expand 〇〇 business.
◇Provide medical consultation to team members and help manage protocol related medical questions. Communicate clearly with project team members and clients, maintaining open communication to ensure all procedures are followed appropriately.

Provide therapeutic training and protocol training on assigned studies, as requested.
◇Perform listing reviews as specified in the client contract and data validation manual, including review of coding listings and/or full safety listings as well as use of Patient Profiles and other tools to assess for potential safety signal.

◇This position will be assigned to APAC components of global or regional studies. Including but not limited to global/regional studies with Japan component. This person will also take care of a major responsibility of ICCC review, therapeutic area training to clinical team in 〇〇, supporting business development in 〇〇, and clients requests including F2F visits to investigators, KOLs and sites in Japan.
"

5.0日 ～

(月～金) 09時00分 ～ 18時00分
"9:00～18:00（東京本社、大阪オフィス）
※フレックスタイム制
（コアタイム／11:00～16:00　標準労働時間／8時間　休憩時間／60分））"

なし

日曜日、祝日、土曜日

季節休暇、年末年始、その他休暇、初年度有給休暇(10日)

なし

1000万円 ～ 応相談

健康保険、雇用保険、労災保険、厚生年金

あり

なし

【給与】
年収1000万円～（目安の金額になります）
※経験・スキルによります。

"【必須条件】
・日本の医師免許。PhDはあれば尚可。
・5年以上の臨床経験必須
・専門領域を有していれば尚可。企業経験は不問
・英語ビジネスレベル
【歓迎スキル】
・海外留学経験
※交通費：新幹線代は認められません。