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  2. Tokyo Job seeking
  3. Sr Clinical Trial Manager

Sr Clinical Trial Manager

1000 〜 1400 ten thousand JPY

  • RGF HR Agent
  • Location: Tokyo
  • Japanese level:None(+Studying) │Required length of experience:Uncategorized
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Date:2019/12/10~2020/06/07

Job summary

Job category Professional (Consulting / Finance / Real Estate / Professional Services)/Professional Services (Health Care / Welfare / Education / Instruction)
Industry Health Care/ Other Health Care
Employment type Uncategorized
Position level Other
Number of openings 1
Desired entry time -
Required language skill

English (Business)

Foreign language competence -
Working hours Others
Welfares / Leave systems
Assistance in visa application -
Number of foreign employees -

Work details

Company Overview
Global Pharmaceutical Company

Job Description
Specific Responsibilities:
• Acts as Post-Marketing Study Lead with support by CPM.
• Serves as a chair person of cross-functional study management team to manage entire PMS activities in Japan in close collaboration with ClinOps, PVE (Pharmacovigilance and Epidemiology), Clinical Research, Regulatory Affairs and Biometrics in GSJ and HQ.
• Contributes to develop PMS protocol (including PMS plan in the Japan Risk Management Plan: J-RMP) and CRFs in collaboration with functional team in Japan/HQ.
• Supports CPM and prepares for negotiating with PMDA about the protocol and CRF design based on the scientific approach and PMS result by preparing response to PMDA queries.
• Proceeds CRO selection process including preparation of RFP (Request for Proposal), CRO selection and Work Order execution according to SOP in collaboration with appropriate function in Japan/HQ with minimum support by CPM.
• Oversees budget and forecast process for payment to CRO, clinical sites and translation vendors.
• Communicates with PVE personnel and drafts safety reporting strategy of PMS studies in collaboration with functional team in Japan/HQ.
• Ensures to prepare PMS part of J-PSR (Japan Periodic Safety Report) and Re-examination report in English and Japanese in collaboration with appropriate function in Japan/HQ with minimum support by CPM.
• Oversees CROs and resolve fewer complex issues, or complex issues with support, to ensure study quality, complying with work order, SOPs and regulatory requirements within agreed timeline.
• Prepares training plan and materials and gives training to GSJ therapeutic specialist (aka. Medical Representatives) and CRO personnel with support, if necessary.
• Prepares and maintain GPSP SOPs, prepares training plans and gives necessary trainings to those in Japan/HQ who involve PMS activities with support, if necessary.
• Deals with the Audit/Inspection by Regulatory authority or Regulatory compliance with support by CPM.
• Prepares a TMF plan and manages to archive documents based on the TMF plan with support, if necessary.
• Support early phase (Ph.2 or 3) clinical trial, if needed.

Requirements
Essential:
 Must have demonstrated organizational /project management skills to manage simple/small project or multiple /complex projects simultaneously with support by CPM.
 Hands-on involvement is a must (effective use of external resources).

Desirable:
 Strong communication and influence skills and ability, or potential to create a clear sense of direction is necessary
 Experience in PMS at least 5 years.
 Registered Pharmacist is preferred
 Experiences in PMS planning and execution.
 Through knowledge and understanding of Japanese Regulations, ICH Guidelines and GPSP governing the conduct of PMS is required
 Good skills of communication in Japanese and English (>750 TOEIC)
 Experiences in selection and oversight of CROs and vendors.
 Proven good communication skills and evidence of able to work in cross functional teams
 Travel is required

About interview

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Name of person in charge of hiring:

Sr Clinical Trial Manager

RGF HR Agent

1000 〜 1400 ten thousand JPY

Close

Company overview

RGF HR AgentSr Clinical Trial Manager RGF HR AgentSr Clinical Trial Manager

RGF HR Agent

Human Resources / Education / Consulting / Professional Services /Staffing / Recruiting

RGF (Recruit Global Family) is the overseas corporation of Recruit Holdings Co., Ltd., Japan's largest talent comprehensive service and information service group enterprise, has started for more than 50 years, based on excellent business philosophy and management experience. Transcend national borders, we will discover new opportunities and possibilities worldwide.
RGF HR Agent provides solid support for the hiring activities of companies and the job-hunting activities of applicants as a general HR service company.
We provide not only regular recruitment but also RPO (Recruitment Process Outsourcing), contracts and so on. We deliver comprehensive services that could only be offered by RECRUIT=RGF, which is number one in Japan in the field of talent introduction, temporary staffing and recruitment information advertising. Having thoroughly met the needs of leading companies in Japan, we will also provide our consummate, high-quality services overseas. RECRUIT=RGF, which is number one in Japan, will continue taking on the challenge of becoming number one in the world.

JAPAN: RGF HR Agent Japan (CDS)
Address: 東京都渋谷区広尾1-13-7恵比寿イーストビル2F
TEL (+81)3-6422-4400
Website: http://www.rgf-hragent.asia/en/japan

CHINA: RGF HR Agent (Shanghai)
Address: 上海市淮海中路8号 蘭生大厦9F
TEL (+86) 21 5331 8000
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Suzhou)
Address: 蘇州市工業園区蘇州大道西1号 世紀金融大厦1615室
TEL (+86) 512 6262 3595
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Beijing)
Address: 北京市朝陽区東三環中路39号建外SOHO,A座902室
TEL (+86) 10 5869 0121
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Tianjin)
Address: 天津市和平区南京路189号津汇広場一号楼1106单元
TEL (+86) 22 2331 1169
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Dalian)
Address: 大连市高新技术产业园区黄浦路537号(七贤路)泰德大厦811室
TEL (+86) 411 8445 7095
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Guangzhou)
Address: 广州市天河区林和西路161号 中泰国际广场A塔1309室
TEL (+86) 20 8527 4585
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Shenzhen)
Address: 深圳市罗湖区嘉宾路2018号深华商业大厦2507室
TEL (+86) 755 8237 5208
Website: http://www.rgf-hragent.asia/china

HONGKONG: RGF HR Agent Hong Kong Limited
Address: Unit 2206, 22/F, Wu Chung House, 213 Queen’s Road East, Wan Chai, Hong Kong
TEL (+852) 2537 2557
Website: http://www.rgf-hragent.asia/en/hongkong

VIETNAM: RGF HR Agent Vietnam Co., Ltd.
Address: RM903 Central Plaza 17 Le Duan St., Dist 1 Ho Chi Minh City
TEL (+84) 8 3911 5800
Website: http://www.rgf-hragent.asia/en/vietnam

THAILAND: RGF HR Agent Recruitment (Thailand) Co., Ltd.
Address: 689 BHIRAJ TOWER at EmQuartier, 23rd Floor, Room No. 2304-2306 Sukhumvit Road, North Klongton Sub-District, Vadhana District, Bangkok 10110
TEL (+66)2-021-0333
Website: http://www.rgf-hragent.asia/thailand/

SINGAPORE: RGF HR Agent Singapore Pte. Ltd.
Address: 71 Robinson Road #05-04 Singapore 068895
TEL (+65) 6221 7437
Website: http://www.rgf-hr.com.sg/

INDIA: RGF Select India Private Limited
Address: 704-705-706, 7th Floor, Vatika City Point, MGRoad, Gurgaon 122002
TEL (+91)124 4139711
Website: http://www.rgf-hragent.asia/en/india

INDONESIA: PT. RGF Human Resources Agent Indonesia
Address: Jakarta Office: Graha Pratama, P1F (21F), Jl. M.T.Haryono Kav. 15, Jakarta 12810, Indonesia
TEL (+62) 21 8378 2866
Website: http://www.rgf-hragent.asia/en/indonesia

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