( 概要 ) 日本国内で治験を実施するためのオペレーションチームリーダーとして,国内外のステークホルダーとの協議•交渉など,エキスパートとしてのコミュニケーションを通じ,品質を確保した臨床試験を計画通りに遂行する。 ( 具体的な業務例 ) •試験実施施設の選定戦略,症例組み入れプラン•戦略の作成及び実行 •試験遂行のための現場の責任者としてモニターへの指示及びモニターへの助言 •試験全体の進捗および GCP , SOP に沿った臨床試験の実施と品質の確保 •国際共同試験の場合,海外担当者からの指示の正確な把握及び協議を含めた円滑なコミュニケーション •試験における Risk & Issue Management •治験契約締結交渉,データ固定, GCP • SOP に基づくモニタリングに対するモニターへのフォロー •チームビルディング,ステークホルダーマネジメントによるチーム作り •社内の改善活動 / Task force team への参加 •試験全体の予算の管理 Position Summary: The
Are you passionate about improving patient outcomes? Do you have experience in medical affairs and a desire to make a difference in the healthcare industry? We are looking for a Medical Advisor to join our dedicated
* Responsible for preparation and submission of expedited and periodic safety reports to Regulatory Authorities, Ethics Committees and Investigators, adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and
Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – to enable our customers to make the
Job Description Technical Services Manager (Japan) At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – To enable our
Job Description Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.
Job Description When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected,
Are you passionate about implementing Health Economic Outcomes Research (HEOR) projects? Do you want to make a meaningful impact on patient lives? We are looking for a HEOR Specialist to join our Market Access team at Novo
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
optimal quality and as per MS processes without any errors or duplication of efforts • Resolves L1 / L2 tickets related to Argus config issues (System and Business), Custom E2b profiles, Configuring Argus Aggregate and Periodic
