Clinical R & D ・ Jobs in Japan search results

We will leave the overseas clinical trial manager to a pharmaceutical manufacturer specializing in rare diseases.

■ Collecting and summarizing information from materials including English literature
■ Preparation of Western IND materials (selection of necessary materials, translation support instructions, coordination with consultants, etc.)
■ Contact or coordination with Western KOLs, patient groups, etc., planning of clinical trial implementation plans, etc.
■ Negotiations, selection, and management with Western CROs, etc.
■ Coordinati ...

Create and maintain all relevant clinical project documents and tools pertinent to the study, ensuring compliance with company, applicable regulatory and customer requirements.


Description

- Lead a team of Clinical Operations (CRAs, In House CRAs and Start Up Leads)
- Apply and draw conclusions between project activities/ deliverables and project metrics and initiating measures to improve metrics.
- Proactive risk identification and management, including implementation of CAPAs where applicable


Profile

- Experience managing CRAs/ specia ...

In charge of all Clinical Operations in Japan incl. planning, implementation and monitoring of ongoing activities and projects. Based in Osaka or Tokyo, responsible for office and remote staff.


Description

- Provide leadership in the implementation of quality initiatives and business processes
- Provide strategic direction to all departments.
- Ensure appropriate profitability for all the projects conducted in your region


Profile

- experience in a CRO or pharmaceutical company
- team management and budgeting experience
- clinical t ...

[Summary]

● Assessing, quoting and managing medical manuscript writing and development projects
● Providing feedback to and managing freelance experts (including editors, reviewers, medical writers and translators)
● Assigning work to freelancers and participating in freelancer recruitment and on- boarding as needed
● Working closely with other teams (account managers, marketing, education, product) to provide highest-quality services and products
● Potentially working with our Medical Communications team to manage medical writing projec ...

[Summary]

● Assessing, quoting, and reviewing of Author Services deliverables from a range of subjects particularly within the biomedical sciences fields.
● Providing feedback to and managing freelance experts (including editors, reviewers, medical writers and translators).
● Assigning work to freelancers and participating in freelancer recruitment and on- boarding as needed
● Working closely with other teams (account managers, marketing, education, product) to deliver highest-quality services and products
● Managing the preparation and ...

* Build an effective and efficient clinical project team. Provide mentoring and coaching to other project team members
* Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables for high-profile, significant, and more complex clinical trials according to GCP, all applicable regulations SOPs


Description

* Planning: Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for success ...

* Responsible for clinical trial management of multiple studies to contribute to the development of innovative therapies and lifcechanging solutions for patients suffering with structural heart diseases
*

Act as subject matter expert for assigned clinical studies, including the planning, implementation, oversight, project management, and completion of clinical trials


Description

* Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliver ...

* Protocol development and clinical strategy within assigned TA, with close collaboration with the Head of Clinical Research Japan

* Integral in the scientific planning, execution and reporting of Japanese clinical studies for compounds within the inflammation, infectious disease and oncology therapeutic areas.


Description

* Act as local scientific expert for assigned clinical research activities, addressing questions from internal functions and external Japanese physicians and research scientists.

* Provide scientific support to function ...

* Design and execute biostatistic aspects of clinical studies in Japan

* Operate as a subject matter expert in BIOS within the Japan clinical team


Description

* Responsible for directing the biostatistics activities in collaboration with HQ, from trial design, execution, analysis, and data interpretation.

* Serve as regional subject matter expert for specific programs and TAs and provides leadership to support all clinical studies, regulatory submissions, and publications for the program or therapeutic area.
*

Participate in develo ...

Key Duties and Responsibilities
• Research and analysis on the events/adverse events including device deficiencies, and reports to regulatory authorities (individual cases, various periodic reports) in a timely manner.
• When the safety issue arises, lead to define the appropriate safety measurement through the communication with the related Global and external parties.
• Ensure full compliance with applicable pharmacovigilance regulations in Japan.
• Oversee all activities or responsibilities that are delegated to external parties. ...

● Management of progress, quality, budget, etc. in a global clinical development project led by Japan
● Summary of leaders in each country
● Coordination with sponsors
● Timeline management of clinical development projects
●Proposals related to projects, conclusion of contracts, internal (Japan and overseas branch offices) coordination, and progress management
●Project budget management and coordination
*This is a project where not only Japanese nationals but also foreign nationals are enrolled. ...

●Assembling and implementation of nucleic acid drug screening evaluation system
●Promotion of joint research with other companies and academia (including management) ...

【Establishment of genomic research (fertilized egg production)】
●Basic/applied research/development (chemical experiment, bio experiment, etc.)
●Molecular biology experiment
●Biochemistry experiment
● Algorithm development for economic and genetic traits
● Data aggregation and statistical analysis that required scientific knowledge
●Various inspection work, reagent adjustment
● Image and video analysis ...

Development of new prescription drugs ...

Monitoring work in clinical development ...