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

年収:800万 ~ 1300万

ヘッドハンター案件

部署・役職名 Clinical Assessment Manager
職種
業種
勤務地
仕事内容 Clinical Assessment Manager

Job Summary
Clinical Assessment Manager works in a pivotal role managing communication and activities with Clinical Research Sites, Investigators, and Clinicians to prepare for and complete Clinical Assessments.

Reports To: Associate Director, Site Management
Department: Site Services
Division: Patient Engagement
Location: Tokyo, Kanto, or Kansai preferable. Option to work remote.

Primary Requirements:
- Experience with sites, scheduling/ coordinating priorities, process improvement [Must].
- General understanding of Rater Assessments for CNS studies.
- Background as Senior Level Research Coordinator, Research Nurse or other similar experiences [Nice to have].
- Organized problem solver who can forecast and resolve issues.
- Ability to work independently, and as a Team.
- Internal and External Communication.

Qualifications/ Experience:
- At least five (5) years of previous research experience and/or clinical experience is required.
- Must possess Research Design, Patient Care Practices, GCPs, FDA regulations, Medical Terminology, Knowledge.
- Experience with eCOA platform is a plus.
- Ability to read, understand, assimilate Protocol Specified Requirements.
- Ability to ask questions as needed to gain knowledge and understanding.
- Ability to communicate and work effectively with a diverse team of Professionals.
- Excellent organizational, prioritization, time management skills
- Detail-Oriented, People-Oriented, Self-Confident, Flexible and Adaptable to change.
- Proficient in common office technology e.g. Microsoft tools, teleconferencing, etc.

Essential Responsibilities:
To perform Clinical Assessment Manager successfully, you need to be able to:
- Partner with Project Management, Clinical Science and eCOA teams to deliver Project based Services
- Ensure Company Standards, Expectations, Clinician Services are according to Standard (measured by Visit Availability, Wait
Times, Clinician Utilization, Safety Reporting Compliance)
- Take Responsibility for resourcing Principal Clinician (Internal and External)
- Make sure that study protocols scheduling of study assessments with sites and clinicians are met.
- Prepare presentations, conduct training of Investigators at Investigators´ Meetings and SIVs, at any stage during the trial, when required.
- Develop project specific manuals for Clinical Assessment Services.
- Mitigate Clinical Assessment related risk.
- Onboard new clinical sites to scheduling system, project specific assessment services.
- Track and report Project progress, including Subject, Site, Clinician Compliance, Scheduling Metrics, Risk Related Metrics.
- Monitor Site Compliance with subject visits outlined in Study Protocol.
- Monitor Query Notification, Resolution process with sites to protect Data Integrity.
- Support Clinical Data reviews, Perform Clinical Data Risk Assessments, with Clinical Scientist.
- Track Subject Visits and ensure Compliance with Risk Reporting Process by Monitoring Reports.
- Develop/Write site facing documents, internal project plans specific to provided clinical assessment services.
- Onboard sites with project start up, Clinical Assessment relate Equipment testing, Mock assessments, Closeout activities.
- Support Custom Report Generation by reviewing protocols for data tracked and monitored in the clinical eCOA system.
- Develop Project based Training materials for Sites, Internal Clinicians.
- Support Sites, Investigators, Clinicians with Clinical Assessment Compliance.
- Monitor Alerts of Investigators/Sites, Clients, Clinical Science team when Patient Risk has been reported.
- Make sure Patient Risk is acknowledged by Investigator/Site and Client.
- Develop Workflow Procedures for Study Team based on specific project and study protocol.
- Serve as primary point of contact for Clients, Investigators/Sites by having a positive, professional manner.
- Actively practice and maintain adherence to FDA regulations and regulatory guidelines for conducting clinical trials.
- Contribute to fostering team spirit and productivity by establishing communication lines within the project team.
- Attendance and punctuality are essential functions of the position.

Supervisory Responsibilities
Supervise and Manage Clinical Assessment Coordinator(s).
Support staff as the Company expands.

Travel requirements:
Clinical Assessment Manager role may require up 20% travel, domestic or international, including overnight and weekend stays, depending on project needs and office location.

Education Requirements:
Bachelor’s Degree in Health Care, Life Sciences or related field.
Demonstrable related experience in Pharmaceutical / Biotechnology industry.
CNS clinical trials experience is an advantage.

労働条件 Reports To: Associate Director, Site Management
Department: Site Services
Division: Patient Engagement
Location: Tokyo, Kanto, or Kansai preferable. Option to work remote.
応募資格

【必須(MUST)】

Primary Requirements:
- Experience with sites, scheduling/ coordinating priorities, process improvement [Must].
- General understanding of Rater Assessments for CNS studies.
- Background as Senior Level Research Coordinator, Research Nurse or other similar experiences [Nice to have].
- Organized problem solver who can forecast and resolve issues.
- Ability to work independently, and as a Team.
- Internal and External Communication.

Qualifications/ Experience:
- At least five (5) years of previous research experience and/or clinical experience is required.
- Must possess Research Design, Patient Care Practices, GCPs, FDA regulations, Medical Terminology, Knowledge.
- Experience with eCOA platform is a plus.
- Ability to read, understand, assimilate Protocol Specified Requirements.
- Ability to ask questions as needed to gain knowledge and understanding.
- Ability to communicate and work effectively with a diverse team of Professionals.
- Excellent organizational, prioritization, time management skills
- Detail-Oriented, People-Oriented, Self-Confident, Flexible and Adaptable to change.
- Proficient in common office technology e.g. Microsoft tools, teleconferencing, etc.

【歓迎(WANT)】

- Background as Senior Level Research Coordinator, Research Nurse or other similar experiences [Nice to have].

更新日 2021/06/01
求人番号 1768915

採用企業情報

この求人の取り扱い担当者

この求人に含まれるキーワード

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

メールアドレス ※ メールアドレスは公開されません
パスワード ※ 半角英数字記号10文字以上64文字以下で入力してください パスワードの安全度:
現在の年収
新規会員登録(無料)

新規会員登録(無料)ボタンをクリックすると個人情報の取り扱い、及び、利用規約に同意したものと見なされます

転職が決まりご報告いただいた方にはお祝いを用意しております。

ページ先頭へ