1. 転職サイト ビズリーチ
  2.  > 
  3. 求人検索
  4.  > Clinical Research Manager

転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です

新規会員登録（無料）

Clinical Research Manager

年収：800万 ～ 1300万

ヘッドハンター案件

部署・役職名 Clinical Research Manager
職種
業種
勤務地
仕事内容 ▪ CRA Management
Hire, train, and retain a team of CRAs.
Assess CRA performance and monitoring competency.
Identify training needs and implement targeted development plans.
Conduct CRA Assessment Visits and co－monitoring as needed.

▪ Trial Oversight
Allocate CRA resources for new trials in collaboration with Start－up and Clinical Monitoring teams.
Oversee site selection, activation, patient recruitment, and data flow.
Review recruitment progress and support corrective strategies with CSMs.
Ensure quality monitoring and site performance.

▪ Quality ＆ Compliance
Review and approve monitoring visit reports.
Ensure adherence to GCP, ICH, SOPs, and IRB/EC requirements.
Support audits and inspections, and manage CAPA implementation.
Monitor CRA compliance with SOPs and training requirements.

▪ Budget ＆ Productivity
Monitor and approve CRA travel and expenses per T＆E policy.
Track CRF data entry and SDV status.
Ensure timely and complete TMF maintenance and QC.
Review trial budgets and provide input on accruals and forecasts.

🔹 Japan－Specific Responsibilities
▪ Local Operations
Support the Senior Director in building the Japan organization and local SOPs/WIs.
Conduct country－level feasibility assessments.
Manage vendors and FSP partners in Japan.
Take on trial management responsibilities when needed.
Conduct Site Motivation and Site Engagement Visits.
Prepare for and support PMDA inspections.
🔹 Supervisory Duties
Mentor and oversee CRAs and team members.
Provide training and support for site visits.
Conduct performance appraisals and provide feedback.
Identify development opportunities for direct reports.
応募資格

【必須（MUST）】

🔹 Education
Bachelor’s degree or higher in a scientific or healthcare－related field （preferred）.
🔹 Clinical Operations Experience
Minimum of 5–6 years of relevant experience in clinical operations.
🔹 Management Experience （by level）
Associate CRM: 1–3 years of people or project management experience in clinical research （biotech, pharma, CRO, or related field）.
CRM: 3＋ years of people and project management experience in clinical research.
Senior CRM: 5＋ years of people and project management experience in clinical research.
🔹 Technical ＆ Regulatory Knowledge
Documented training and application of GCP, ICH, and regulatory guidelines.
Strong understanding of clinical trial monitoring and execution.
Familiarity with international drug development processes and regulatory standards.
🔹 Leadership ＆ Communication
Proven team leadership and performance management skills.
Strong written and verbal communication skills with internal and external stakeholders.
Ability to manage complex compliance issues and problem－solving at clinical sites.

リモートワーク

可

「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります
受動喫煙対策

屋内禁煙
更新日 2025/05/16
求人番号 4687014

採用企業情報

この求人の取り扱い担当者

転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です

新規会員登録（無料）