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Clinical Trial Study Manager, US Pharma, 10-13M
- Lead and be a part of potentially blockbuster drug clinical trials
- High salary for this position type (up to 13M)
About Our Client
A US pharmaceutical company has a strong drug development pipeline and is looking for a Clinical Study Manager to handle efficient clinical trials. The company is not a huge company, and still has less than 200 employees in Japan. Because of this, the environment is very exciting and employees have the opportunity to be involved in a wide range of tasks. The company culture is a healthy mix between Japanese and International, and the office is brand new in an excellent central Tokyo location.
Clinical project management of a clinical study
Create and drive study level timeline
Develop overall feasibility concept and enrollment plan
Develop and manage study budget
Provide input on operational aspects of the protocol
Ensure regulatory compliance and GCP compliance
Responsible for being the point of contact for periodic audits
Responsible for/contribute to vendor selection and management including issue escalation
Develop and manage Study Management plan and all associated documents (i.e. vendor oversight plan)
Collaborate with CS&L team to plan and coordinate IMP and non-IMP supplies
Plan, facilitate and lead internal meetings as well as act as the lead for vendor meetings
Ensure monitoring plan is developed and consistently executed
Contribute to development of proactive strategy and corrective action plan to address study issues
Assigns and documents study specific roles and responsibilities to internal and external team members
Facilitate and coordinate communications with external provider
Ensure Clinical Operations team and external partner receive study specific training
Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations
Support regulatory submissions
Support audits/inspections and resolution of findings
The Successful Applicant
Bilingual, Business English and Fluent Japanese required
Bachelor degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
* As a guide, a minimum 6+ years' relevant clinical research (or related) experience within the pharmaceutical industry (CRO OK).
* A solid understanding of the drug development process, and specifically, each step within the clinical trial process.
* Experience in overseeing global clinical trials (pharmaceutical or research institute).
* Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.
* Ability to work independently with some oversight in the support and/or management of clinical trial execution.
* Postgraduate qualifications.
* Experience in scientific/medical research.
* Specialist knowledge (e.g. CNS and/or Immunology).
* Excellent interpersonal and decision making skills. Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives.
* Excellent understanding of all tasks involved in a clinical development program from developing a protocol through finalizing a clinical study report.
* Ability to plan and ensure execution and completion of clinical program(s) to the highest ethical and scientific standards.
What's on Offer
Chance to work at a small to mid-sized biopharma company with strong clinical pipeline with potential blockbuster drug status
Central Tokyo location close to the station in a new office
Stable company with multiple product launches over the next 2 years
Up to 13M salary