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- Contribtute to Greater Outcomes for Patients across JAPAC
- Develop Lifechanging Medicines within the Oncology Space
About Our Client
- Leading multinational pharmaceutical company in the field of oncology and immunology
Job Description
Plan and lead the implementation all study startup/conduct/close-out activities
Evaluate innovative trial designs (collaboration with Japan Clinical Trial Physician/Japan Clinical Development Lead)
Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing)
Site-facing activities such as training and serving as primary contact for clinical questions
Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team
Clinical data trend identification; provide trends and escalate questions to Japan Clinical Trial Physician
Develop clinical narrative plan; review clinical narratives
Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities
Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
Collaborate and serve as primary liaison between external partners for scientific advice
The Successful Applicant
- Licensed MD / PhD / PharmD strongly preferred
- Native level Japanese
- Fluent English (spoken and written)
- Clinical practice and basic research in oncology
- 5 years' of experience in clinical development
What's on Offer
- Make a meaningful impact on the lives of patients globally
- Stable career path, overseas experience opportunities
- Contribute to development of clinical assets within haematology and solid tumour area
Contact
Ed Marsden
Quote job ref
JN-012022-5244223
Phone number
+813 6832 8981
Job summary
- Function
- Healthcare
- Specialisation
- Healthcare
- What is your area of specialisation?
- Healthcare / Pharmaceutical
- Location
- Tokyo 23 Wards
- Job Type
- Permanent
- Consultant name
- Ed Marsden
- Consultant phone
- +813 6832 8981
- Job Reference
- JN-012022-5244223
- Company Type
- Foreign Multinational
