Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life＜ポジション名＞ Senior Clinical Research Specialist(モニター職)
＜勤務地＞ 東京または大阪 ※担当施設の対象は全国となります
＜部門について＞
モニタリング部門は、日本のCRMS部門（Clinical Research & Medical Science）と連携し、臨床研究の推進を支える重要な役割を担っています。治療領域ごとにグループ制を採用し、製品や疾患への深い理解を基盤に、試験の精度と効率を高めています。施設マネジメント全般を担当し、治験実施医療機関との強固な関係構築を通じて試験環境を最適化します。契約管理、進捗確認、品質保証、リスクマネジメントなど幅広い業務を包括的にサポートし、規制要件と倫理基準を遵守した運営を徹底しています。CRMS部門と一体となり、科学的エビデンスに基づく価値創出と患者安全を最優先に、革新的な医療の提供に貢献しています。
＜業務内容＞
治験の安全性・信頼性を担保し、日本の規制に適合した効率的な試験運営を支えるため、以下のような業務を実施していただきます。
治験、市販後臨床研究および市販後調査の計画・実施・進捗管理と報告書作成
担当施設における手続き業務、モニタリングならびに監査対応
関連文書の作成および確認
内部・外部関係者との良好な関係構築
重篤有害事象や逸脱の報告と対応、および医療機器の不具合報告と対応
担当試験のモニターチームのリード (リードモニター業務)
下位あるいは低経験値モニターのティーチングならびにコーチングによる育成
その他、組織やプロジェクトに必要な業務
＜Must Haves＞
Job Experience
医療機器会社、製薬会社、またはCROでの5年以上の治験モニター経験
大学病院等の基幹病院の担当経験
Skill / Knowledge
GCPに関する深い知識
英語でのSOPや業務関連文書の読解、モニタリング報告書作成スキル
高いコンプライアンス意識と品質意識
Competency
優れたコミュニケーション能力と問題解決スキル
自発的に考え能動的に行動できる能力
チームワークを重視し、協力して業務を遂行できる能力
積極的に学び続ける姿勢
Education
学士以上（医学、薬学、看護学、生命科学、工学関連分野が望ましい）
＜Nice to Haves＞
Job Experience
循環器や心臓血管領域の担当経験
担当試験の疾患領域におけるKOLマネジメント経験 (KOL施設担当モニター含む)
役割を持ったPMDA対面助言の経験
役割を持った薬事申請におけるPMDA対応経験
Skill / Knowledge
ISO 14155の知識
＜Working Style＞
勤務形態: 出勤と在宅勤務のハイブリッド (最低出勤回数：1回/月)
出張: 宿泊を伴う出張および突発的な外勤への対応が可能であること
会議: グローバル会議への早朝あるいは夜間参加が可能であること
緊急対応: 重篤有害事象発生等への迅速な対応が可能であること
ベネフィット
メドトロニックでは、会社の成功と社員の成長は共にあるべきであると考えています。社員一人ひとりの経済的、身体的、精神的な幸せを高められるような、充実した福利厚生と報酬プログラムを用意しています。
年間最大36万円の育児費用補助
家族に介護が必要になった場合や養子縁組の際などに6週間取得できる休暇制度
ベビーシッターや保育園のマッチングサービス
メンタープログラムやe-learningなどを含むキャリア開発
女性の活躍を支援する社内キャリアネットワーク
自社株購入制度 etc.
その他
＜諸手当＞
通勤手当、勤務時間外手当、休日勤務手当 etc.
＜休日＞
土曜日、日曜日、祝祭日 etc.
＜休暇＞
年次有給休暇、公傷病休暇、生理休暇、産前産後休暇 etc.
＜勤務時間＞
9：00～17：30
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.
If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected].
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
Skills Required
- 7+ years of clinical monitoring experience in a medical device or pharmaceutical company
- Experience leading a monitoring team of 3 or more
- Experience with major hospitals such as university hospitals
- Deep knowledge of GCP
- Skills in reading and writing SOPs and reports in English
- Strong compliance and quality consciousness
- Excellent communication and problem-solving skills
- Ability to think proactively and act actively
- Teamwork and collaboration capability
- Willingness to continue learning
- Bachelor’s degree or higher in relevant fields such as medicine or life sciences
Medtronic Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Medtronic and has not been reviewed or approved by Medtronic.
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Parental & Family Support — Paid leave for birthing and non-birthing parents is positioned as notably generous, with additional Family Care Leave available for a range of caregiving needs. Fertility, adoption, donor, and surrogacy support adds depth for different paths to family-building.
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Retirement Support — A 401(k) match and an employee stock purchase plan are presented as meaningful long-term savings tools. Scholarship and tuition programs further reinforce financial security beyond salary.
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Healthcare Strength — Medical, dental, and vision coverage is consistently described as a strong part of the total rewards package. Mental health resources, critical illness coverage, and wellness supports broaden the overall health offering.
Medtronic Insights
What We Do
Medtronic is a global healthcare solutions company operating in approximately 160 countries. We are committed to improving lives through our medical technologies, services, and solutions. Since our beginning, 60 years ago, our Mission has remained the same: to alleviate pain, restore health, and extend life for people around the world. The Mission is our ethical framework and inspirational goal guiding our day-to-day work. It reminds us that our efforts are transforming millions of lives each year. To meet the needs of patients and healthcare professionals around the globe, we operate from more than 370 locations in approximately 160 countries.
