Introducing RTSM system with Client Services Read (CSL)
Deliverable preparation and schedule management based on the project management SOP
Testing and modification at the system construction stage
Support for cooperation between RTSM and other companies' systems
Project management for RTSM system implementation
Understand clinical trial protocols, create specifications, and build systems.
Leads the setting of Kick Off Meeting with clients and the design session for test construction.
Work with a Business Systems Analyst (BSA) to prepare and schedule deliverables based on the Project Management SOP
Support for cooperation between RTSM and other companies' systems.
Attend client audits. ...
The Product Support Specialist will provide study support to the delivery team after the study is deployed to production. The Product Support Specialist is responsible for the following: Perform production study support as directed. Collaborate with the Director or CE in providing support to the CE Associates and the Delivery team to help drive the most professional end user experience in the clinical trial industry. Play a pivotal role in the interrelationships between the Delivery team and CE.
* Supervise overall Vaccines Medical Affairs and Tactics
* Lead and Manage the Vaccines Medical team
* Medical tactics and strategy creation for Japan
* Build Evidence Generation plan and oversee Phase IV trials
* Solid collaboration and insight share with commercial/marketing/R&D
* Team Management
* Strong involvement in global medical strategy
* MD - Medical Doctor
* Medical Affairs experience and successful track record
* Vaccines experience
* Business English proficiency
* Non-Japanese speakers wi ...
* As a member of trial team, participate in site monitoring activities throughout the course of a trial, to safeguard the protection of the trial subject, reliability of the trial results, compliance with study protocol, ICH-GCP and applicable regulations and ensure inspection readiness at all times.
* Attendance of training for internal CRA appointments
* Meetings and appropriate communication with internal and external stakeholders as required for the conduct of the study
* Research into the selection of medical institutions ...
An R&D Engineer role is now available at a multinational clinical diagnostics company. The applicant selected will ensure the successful development and optimisation of IVD products to secure brand positioning.
* Facilitate research and development activities for new products
* Conduct raw material tests and research
* Design R&D and test plans
* Create test reports and data records
* Lead performance analysis, feasibility studies, and product evaluations
* Perform maintenance of laboratory equipment
The Sponsor Support Analyst will lead client support of the RTSM application after study go-live. The Sponsor Support Analyst is responsible for the following:
Primary sponsor contact after study go-live as the expert in 4G Clinical’s PRANCER application, responsible for the client’s overall support experience
Manage sponsor emails, providing support for troubleshooting and requests
Provide timely and professional responses to sponsor requests; proactively provide status updates to ensure stakeholders are in ...
* Oversight, development and execution of clinical studies in line with global strategy. Integrate clinical development objectives with global considerations into strategic business decisions. Ensure clinical, operational and medical governance excellence across all clinical development projects for assigned programs. Lead the preparation of regulatory briefing documents and clinical elements of regulatory submission
* Serves as a primary source of medical accountability and oversight for clinical trials
* Matrix management responsi ...
Responsible for managing a small team of PV specialists/senior specialist who will be conducting local activities in line with required local vigilance regulations.
Ensures talent development and succession planning in place for PV roles within market roles through coaching, mentoring and support
Act as Local Safety Responsible person/Nominated PV contact to local health Authority or local QPPV.
Monitor and report compliance with the requirement of company, industry and local regulatory authority, etc.
Development of the Clinical Development Plan, study design, governance and interpretation of results of a study, and filing strategy and documents of clinical part for Japan. You will have accountability for up to 2 projects at any one time, work collaboratively alongside Japan Medical and Development colleagues, as well as with global Vaccines Development Team.
A Global Provider of specialty solutions in clinical trials particularly in the Psychiatry area or Neurology space.
The Project Manager is responsible for the day-to-day management of client projects and ensures that projects are delivered on time, within budget and according to the agreed upon scope of work. The Project Manager will serve as the bridge between our clients, internal teams and partners in order to manage the operational execution of projects
Lead as an operational interface b ...
External facing clinical representative responsible for the independent clinical management of international clinical trials
• Own scientific responsibility and co-lead each assigned project, along with accountability for ensuring that the scientific integrity is maintained and all necessary analyses and remediations are conducted and effectively communicated
• Actively participate in internal and external project meetings (e.g., weekly external client call, Investigators’ Meetings)
• Review, monitor, and proactively addre ...
[R & D position (prescription development position)]
You will be involved in the prescription of makeup cosmetics and the development of prototypes.
Not only can we take charge of the overall work from specifications to completion, but we can also be involved in all products from cosmetics to colors and fragrances. You can work with great discretion.
[Business content to be entrusted]
・ Cosmetic formulation development (a wide range of products such as foundations, concealers, makeup bases, cheeks, lipsticks, eye shadows, mascaras, etc.) / Selectio ...
* Provide leadership and clinical expertise in support of new product clinical development and approved product expansion.
* Plan clinical affairs projects and activities with accountability for successful completion within scope of project deliverables
* Provide clinical expertise including establishing and approving scientific methods for design and implementation of clinical protocols, investigator's brochure, sponsor ICF, and reports/data presentations/publications.
* Prepare documentation for regulatory submissions required ...