Clinical Trial Manager - up to 15m JPY - 4219837

About Our Client

Advanced oncology focused IVD company
The company develops blood tests for early detection in high-risk populations and monitoring in cancer survivors and provide advanced cancer patients with the information necessary to obtain the right treatment
On the commercial side, they also support drug companies to get new therapies to market faster through utilizing diagnostics in the clinical trial phase as a precise measure of efficacy
In Japan the company is still in growth phase, but have received large investment from major technology company to support in these efforts

Policy and protocol planning for post-marketing surveillance
Develop research policy and plan, and estimate research budget for assigned drugs and indications based on agreement with relevant parties to obtain global approval
GAP analysis and evidence generation (non-regulatory)
Actively participate in GAP analysis and research planning as a partner of TA in the assigned disease area
Publication to be responsible for the preparation and publication of the manuscript as an author in the assigned project
Comply with industry and company rules and ensure that all employees are aware of them (including education)
Propose the most effective solution to inquiries from PMDA regarding post-marketing surveillance for which you are in charge, and negotiate with PMDA through internal agreement
Negotiate with PMDA through internal agreement
Share and communicate information appropriately with all internal stakeholders related to the project to ensure that the study in charge proceeds as planned

Over 5 years of clinical trial work experience in the pharmaceutical / CRO industry, ideally in the oncology space
Work experience related to quality control or quality assurance
Related to new drug approval (GCP compliance survey) or reexamination compliance survey (GPSP compliance survey)
Problem-solving skills
Assertive communication
Knowledge of related regulations (ICH-GCP, J-GCP, GPSP, etc.)
TOEIC 700 points or more (English document preparation, meetings, email correspondence available)
Have the ability to properly identify the gap between the current state of the organization and what it should be, and deal with that gap.

Work in an international environment, clear career development opportunities, contribute to global clinical studies
Contributed to a rapidly growing industry with potential to have huge impact on cancer patients' lives globally

Contact

Ed Marsden

Quote job ref

4219837

Phone number

+813 6832 8981