When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
【職務概要】
臨床試験におけるリスクおよびコンプライアンスマネジメントのスペシャリストとして、プロジェクトおよびアカウントレベルでリスクマネジメントをリードします。Quality Risk Evaluation（QRE）、ダッシュボード、メトリクス、予測ツールを活用した先制的なリスク分析から、複雑なデータの可視化、実行可能なインサイトの提供、そして長期的な改善戦略の推進まで、幅広い職務を担当します
【具体的な業務】
プロジェクト／アカウント単位でのリスク管理やプロセスのリード
クロスファンクショナルチームと連携し、リスクの特定・優先順位付け・対策実行
QRE（Quality Risk Evaluation）などを使ったリスク分析・データ活用・予測
CAPA（是正予防措置）
Root Cause Analysisの推進
SOP逸脱やクオリティイシューの対応・調査・改善
監査・査察対応（audit/inspection readinessの維持）
【必須経験・知識】
臨床開発の実務経験（目安8年以上）をお持ちの方
Quality またはRisk Management活動における実証的経験
ICH-GCPの知識
英語：ビジネスレベル上級（口頭・書面）
【歓迎される経験】
PMDA対応経験、査察対応経験
【このポジションの魅力】
臨床開発プロジェクトのリスクマネジメントおよびコンプライアンスの中核を担い、単なるクオリティチェックに留まらず、リスクの予測・分析・改善までをリードする戦略的ポジションです。さらに、リスクマネジメントおよびクオリティ領域の専門性を高めながら、グローバルかつマトリックス組織の中で影響力を発揮し、主体的にキャリアを発展させることができます。
Skills Required
- 8+ years practical experience in clinical research
- Proven experience in Quality or Risk Management activities
- Knowledge of ICH-GCP
- Business-level advanced English (oral and written)
- PMDA interaction and inspection experience
Parexel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.
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Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
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Retirement Support — Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
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Leave & Time Off Breadth — Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.
Parexel Insights
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
