( 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
■ 職務内容 / Job Description Monitor is responsible to ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site in
Job Description Outbound managerとしてチームのリードをお任せします。倉庫オペレーション業務経験のある方、治験ビジネスにご興味のある方、将来的にキャリアを広げる方向性に興味のある方、英語を使った仕事に挑戦したい方など、ご応募をお待ち申し上げます。 Division Specific Information Clinical Trials Division (CTD) partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time
* Responsible the successful management and communication of all assigned study deliverables, including timeline, budget, resource management. 企業情報 * Internationally renowned CRO with 30 years of experience in providing expert delivery of pivotal Phase 2 &
* At the front line of communication with stakeholders at hospital sites / clinics, youll manage clinical aspects of full-service global trial projects. Your responsibilities will include ensuring timelines, targets, and standards are met for clinical research projects
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 - enabling our customers to make the world
The Medical Director, Clinical Pathologist/Laboratory Medicine provides medical consultative and interpretive support to Labcorp biopharma solutions and its internal and external customers. The Medical Director is responsible for medical decision-making and consultation related to laboratory services and
Job Title Clinical Affairs Senior Manager (IGTD) Job Description Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven
■ 職務内容 / Job Description Medical Communication Scientist (MCS) is a role name in AZKK and is generally known as medical writer. MCS is responsible for the authoring of clinical-regulatory documents and submission packages that communicate the
Are you interested in improving the lives of millions of people, contributing to a company that works with innovation and is a pioneer in addressing the unmet medical needs? Do you have an innovative mindset to
■ 職務内容 / Job Description Responsible for leading and managing clinical delivery team of contributing experts to operationally deliver defined clinical studies, or clinical project work package / activities to time, cost and appropriate quality in Japan R&D. Clinical Operations is
This role entails aiding in the execution of clinical trials in new therapy areas, offering medical insights from engagements with key opinion leaders and professional associations, while reporting to a lead within the team overseeing these activities.
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 - enabling our customers to make the world
所属部署とチーム説明 Global business operation ・新製品投入時の営業サポート・営業チーム、プロジェクト ・チームの編成・国内外の営業およびマーケティング ・サポート・市販後調査（PMS） ・臨床試験業務（フェイズIからフェイズⅣ） ・データマネジメントおよび統計解析・医薬品関連文書の作成―〈治験薬概要、臨床試験計画書、総括報告書、ＮＤＡ（製造/輸入承認申請書）、各種調査書類等〉 ・海外における臨床試験および関連業務 業務内容 ・提案書の文章や予算を作成するための情報を特定し、提案書開発チームと緊密に連携して提案書を作成する ・提案書、再入札、関連文書の文章と予算の作成｜他のチームメンバーにサポートを提供し、担当案件の遂行を支援・プロジェクトのチームリーダーとして、提案書や予算の作成を実行。クライアントコールに参加し、顧客の要求を議論、顧客情報の不一致を確認 ・すべてのドキュメントの品質管理編集を行い、最終決定と顧客および社内部門へ配布・必要に応じて企業データベースを更新、管理し、トラッキングレポートに正確な情報が含まれるようにする 応募要件 • Bachelors Degree and a minimum of 1-year direct experience in Proposals/sales support or equivalent combination of education, training and experience. •
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
This is what you will do: The Medical Affairs Associate Medical Lead prepares a medical plan, which serves as the basis of medical activities of Alexion Pharma GK (AP-J) as a whole, and carries it out
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.
Job Purpose: MSL Manager is accountable for leading and driving performance of MSL department in corresponding therapeutic area. MSL Manager drives MSL department by setting the right business objectives and priorities aligned with global counterpart to
Title: Regulatory Affairs Manager Company: IPSEN K.K. Job Description: Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’
Job Description SummaryJob Overview With global impact and oversight, manage a department of Biostatistics and Statistical Programming staff ensuring that target productivity (project allocations, utilization, and output) levels are met. May fulfill the role of site
