Japanese Pharmaceutical Company
- Manage the project team in the delivery of quality clinical trial management services to achieve the successful overall project completion.
- Maintain an in-depth understanding of customer needs within the project group, to focus on achieving the project's goals and to have knowledge in the assigned therapeutic area. According to his/her knowledge and skills the PM may take over any other tasks, duties, roles and job responsibilities at the discretion of the company and relevant managers.
- Provide a customer focused leadership role and may be assigned to manage multiple Phase I through Phase IV clinical research trials across all functional areas.
- The role holder will assure the understanding and integration of all functions, roles and responsibilities within the clinical project team and will effectively coordinate and manage cross functional teams that deliver clinical projects (Clinical Monitoring, Data Management, Biostatistics, Medical writing, Pharmacovigilance, Regulatory) including vendors, if applicable.
- Monitor adherence to project contract and budget.
- Assist with proposal generation within a multifunctional matrix setting.
- Assist in business development activities to achieve high level of customer satisfaction and therefore ensuring repeat business opportunities.
- University/college degree in a life science field (Master's or other advanced degree is preferred) or equivalent experience or equivalent education.
- At least 5 years of clinical research experience in a CRO, biopharmaceutical company or relevant clinical environment and a minimum of 2 years in team leader function (e.g. Monitor Lead (ML)) or equivalent study coordination or management experience.
- Experience in study management in Japan and/or an Asian country (e.g. Taiwan, Korea) is required.
- Clinical operations management experience (e.g. ML) is required.
- In depth knowledge of the clinical trial process and CRO industry is mandatory for this function.
- Outstanding written and oral English and Japanese skills are required to qualify for this role. An additional language is a plus.
[Preferred Knowledge, Skills and Abilities]
- Knowledge and experience of project management tools; good knowledge of drug development process; drive for results; focus on customers and projects; global orientation /interests; proven expertise in management/ financial control fundamentals; negotiation skills and awareness of regulatory requirements and legal and contract issues; talent at presentations; extensive acumen in problem solving; experience at team/staff mentoring; commitment to quality; strong interpersonal skills; ability to build a team; ability to direct and motivate staff; good internal and external communication skills
5.9 Million yen ~ 9.5 Million yen
(Experiences and skills will be considered)
Monday to Friday, flexible work hours
various social insurance, Full compensation for travel expenses, business trip allowance, Medical Check etc.
Every Saturday and Sunday, holidays, Summer vacation, Year-end and New Year holidays
GW vacation, Annual paid holidays, Company founding anniversary (June 7) , Child-care and nursing care leave system
*125 days of annual holiday
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