鹿児島県指宿市　一般内科　医師　常勤

条件の近いおすすめ求人

• エージェント求人

  🔶【全国どこからでも在宅勤務可】Medical Director

  1000~1300万

  • 安全性評価
  • 臨床試験副作用対応
  • 有害事象対応
  • プロトコル作成
  • プロトコル確認
  • 臨床企画プロトコル作成
  • グローバル治験
  • 試験成績医学的評価
  • 医学的検査
  • 医薬
  • 医療/ヘルスケア
  • 臨床試験
  • 治験モニタリング
  • KOLマーケティングコンサルテ...
  • 手術
  • 外科手術
  • 内科
  • 神経内科
  • 腫瘍内科
  • 血液内科
  • 呼吸器内科
  • 腎臓内科
  • 心療内科
  • 外科

  新日本科学PPD株式会社東京都中央区, 大阪府大阪市, 鹿児島県鹿児島市

  🔶【全国どこからでも在宅勤務可】Medical Director気になる

  もっと見る

  仕事内容

  ◇Minimize potential risk to PPD 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 guidance regarding clinical trials, regulatory documents, and safety issues. Adhere to client SOPs/directives and project specific WPDs for assigned projects. Adhere to PPD’s corporate policies and SOPs/WPDs. ◇Present PPD standard medical processes to clients at business development meetings, investigator meetings, and communicate with various medical communities to explore and expand PPD 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.

  求める能力・経験

  ■Required Qualifications MD (Doctor of Medicine) A certified license of a medical doctor At least 2 years of clinical experience in a hospital setting (Experience in Neurology, Oncology, or General/Internal Medicine is a plus) Ability to work effectively in both Japan-based and regional/global environments Fluency in both Japanese and English ※医師免許は日本のものでなくても問題御座いません。 外国籍の方のご応募の場合は下記2点をご確認くださいませ。 ・日本語スキル：ビジネスレベルで読書き、会話が可能 ・ビザの種類：永住権 or 就労ビザ（期限が入社日以降のもの） ■Work Place ＊Fully Remote *Required to come to the nearest office at least twice a month (Town Hall Meeting and General Meeting).

  事業内容

  臨床試験受託事業（Contract Research Organization） ●臨床第1-4相試験におけるモニタリング ●国内、アジア、およびグローバルの臨床試験のプロジェクトマネジメント ●生物統計解析、データマネジメント ●ファーマコビジランス（安全性監視業務） ●PMDA対面助言に関わる支援を含む薬事業務 ●メディカルライティング ●GCP QA業務（Investigator Site Audit、Vendor Audit、等）