What are the responsibilities and job description for the Clinical Trial Manager/ Senior Clinical Trial Manager position at Rakuten Medical?
Company Profile
Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.
Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.
Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.
Company Profile
Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Illuminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.
Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.
Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 4 countries, Japan, the Netherlands, and Taiwan. For more information, visit www.rakuten-med.com.
Position Summary
The Senior Clinical Trial Manager will be a key manager with responsibilities to manage various aspects of clinical trials from study start-up through database lock in coordination with clinical operations study lead/ leadership. This is an excellent opportunity to join a rapidly growing company to advance novel cutting-edge anticancer therapies into registration trials and later commercialization.
The ideal candidate will have 5-10 years of experience with clinical trial management (including site and CRO/vendor management) with previous experience with oncology (head and neck cancer preferred), combination drug-device studies, and global Phase 2/Phase 3 clinical trial experience. The candidate will have strong working knowledge of drug development process, GCP, ICH guidelines and FDA regulations.
Key Duties and Responsibilities
Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.
We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more for full time employees. We recommend anyone coming onsite to be vaccinated for COVID-19. Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.
Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.
Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.
Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.
Company Profile
Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Illuminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.
Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.
Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 4 countries, Japan, the Netherlands, and Taiwan. For more information, visit www.rakuten-med.com.
Position Summary
The Senior Clinical Trial Manager will be a key manager with responsibilities to manage various aspects of clinical trials from study start-up through database lock in coordination with clinical operations study lead/ leadership. This is an excellent opportunity to join a rapidly growing company to advance novel cutting-edge anticancer therapies into registration trials and later commercialization.
The ideal candidate will have 5-10 years of experience with clinical trial management (including site and CRO/vendor management) with previous experience with oncology (head and neck cancer preferred), combination drug-device studies, and global Phase 2/Phase 3 clinical trial experience. The candidate will have strong working knowledge of drug development process, GCP, ICH guidelines and FDA regulations.
Key Duties and Responsibilities
- Manage operational aspects of clinical trials from study start-up through database lock, with adherence to stated goals, timelines, budgets, and applicable regulatory requirements
- Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements.
- Oversees performance of junior-level clinical operations team members in either a matrix management model and/or as direct reports on their management of study deliverables, and actively provides operational direction and/or general supervision.
- Develop and manage study budget and timelines with clear assumptions
- Track overall spend for the study over the course of the study
- Develop and manage study timelines which includes ability to assess project risks and facilitate appropriate forums with the study team to establish risk mitigation plans.
- Manage study-related vendors including CROs and contract labs
- Serve as point of contact for key vendors and stakeholders
- Responsible for ensuring development and implementation of applicable study plans (i.e., CMP, Communication/Risk Mitigation Plan), protocols/amendments, informed consent templates, eCRF & CRF forms/completion guidelines and site reference manuals/instructions.
- Manage Investigational Product (IP)
- Oversee Co-Monitors to ensure site and vendor compliance (including review of monitoring reports, issue escalation, monitor assessment as monitoring visits)
- Review protocol deviations and data listings as needed to ensure sponsor oversight
- Work cross-functionally to ensure appropriate communication to stakeholders within/across study teams at Rakuten Medical and with vendors
- Review and provide input to vendor contracts, SOWs and assist with invoice reconciliation as needed
- Assist in development of internal SOPs and processes to ensure ongoing compliance and inspection readiness
- Provide frequent study updates to senior management upon request requirements
- Attention to detail and ability to prioritize tasks to meet critical deadlines
- Able to collaborate effectively with the study team, cross-functional team members, and external partners
- Support or manage 1-3 clinical studies
- Bachelor's degree or equivalent in the life sciences or related field
- Minimum 5 years related industry experience with large company or 10 years with smaller company
- Experience with global clinical studies
- Experience managing study timelines
- Previous experience with oncology (ideally head and neck cancer) and/or combination drug-device studies is preferred
- Previous experience managing vendor contracts and budgets
- Strong organizational and project management skills, including ability to multitask and organize/track information
- Strong working knowledge of the drug development process, GCP, ICH guidelines, and FDA regulations
- Proactive recognition of issues as they arise with resolution and/or appropriate escalation to management as warranted
- Excellent interpersonal, written, and verbal communication skills
- Ability to work independently and in a team environment
- Detail-oriented
- Strong computer skills and high level of proficiency with Microsoft Office (e.g. Word, Excel, PowerPoint, Outlook) and Adobe Acrobat programs
- Ability and willingness to travel at times up to 20% nationally and internationally, depending on trial activities
Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.
We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more for full time employees. We recommend anyone coming onsite to be vaccinated for COVID-19. Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.
Salary : $125,000 - $140,000