臨床研究サイトおよび臨床試験参加に関する患者データおよび研究関連情報を監視します。調査員が研究プロトコル、規制要件、良好な臨床慣行に従い、データ検証計画への入力を提供します。患者データのタイムリーかつ正確なモニタリングと、ソースドキュメント、研究記録、およびサイト訪問から、必要に応じて調査関連情報を提供します。 調査サイトおよび監査施設の選択を監視できます。
About The Role
Major Accountabilities
~ 臨床試験を実施する能力を評価するために、潜在的なサイトのサイト選択を実施します。
~ サイト開始訪問を実行し、サイトのスタッフがすべての試験関連の側面に完全に訓練されていることを確認します
~ さまざまな問題を解決するための会社の方針と手順を適用します。
~ 頻繁な社内および外部の連絡先。 特定のプロジェクトの組織を表します
~ コスト センターの目標と目標に貢献
~ ノバルティスとサイトの最前線の連絡は、コラボレーション、サイトエンゲージメントを成功させ、マイルストーンと配達に関するノバルティスの期待に応えることを保証することです
~ 受領後24時間以内にノバルティス製品に関連する技術的苦情/有害事象/特殊事例の報告
~ マーケティングサンプルの配布(該当する場合)
Work Experience
~オペレーション管理と実行
~プロジェクトマネジメント
~組織を代表する。
Skills
~臨床モニタリング
~臨床研究
~臨床試験管理システム
~臨床試験
~コラボレーション
~データの整合性
~ライフサイエンス
~臨床試験報告書
~意思決定スキル
Language
英語
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