(Associate) Clinical Trial Manager
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.
Position Summary
As a member of the sponsor study team, India CTM/associate CTM is expected to be responsible for the followings:
1.Clinical Operation types of work
2.Field Clinical Trainer types of work
CTM/associate CTM will report to India CTM lead and closely work with the internal and external members* to accomplish the team’s goal. In particular, by taking an advantage living in India, India CTM/associate CTM is expected to communicate with India sites physically/remotely to resolve the issues in timely manner especially for those requires on-site support. Therefore, India CTM is expected to travel to India sites as needed.
While primarily work for India operations, CTM/associate CTM will have opportunity to work for global operation or other countries (such as MENA countries) as a part of global clinical operation member.
India CTM has multiple roles, and will be provided sufficient support, consultation and training from RM team members.
Key Duties and Responsibilities
- Clinical Operation types of work as follows, but not limited to:
- Patient screening/enrollment: to support PI/CRC to complete pre-randomization requirement in timely manner (Central Imaging, Screening lab test, Eligibility form etc)
- EDC queries: work with DM and Clinical Scientist, to provide guidance to the sites for data entry and query resolution in timely manner, especially for efficacy and safety queries.
- Ensure PI to use modified RECIST 1.1 for disease assessment. Along with CRA and CS, to conduct on-site co-monitoring to confirm with site source data for disease assessment.
- Oversight CRO CRA for their duties (monitoring report, inventory control, maintenance of site TMF/source data, reporting Protocol Deviations) and will check their level of understanding for study protocol and procedures.
- Site inventory control: along with CRA and CRC, to maintain IP/ID and lab kit in healthy status. In the case of urgent needs for shipment, India CTM will immediately take action for IP/ID or lab kit order so that it doesn’t impact on patient treatment.
- SAE and DD (Device Deficiency): along with CRA, India CTM will ensure that PI promptly reports all SAE/AE/DD to the sponsor, EC and DCGI/CDSCO (via SUGAM portal) according to procedures and timeframe defined in the study protocol, to support especially for India specific safety requirements.
- Field Clinical Trainer types of work: in support from RM Field Medical/Clinical Trainers (FMT/FCT), CTM/associate CTM will support the site to the followings, but not limited to:
- India CTM/associate CTM will liaison and coordinate the communication between PI and RM Medical Monitor to discuss about illumination strategy through on-line pretreatment planning meeting.
- Administrative support of PIT treatment: At Day 2 of each Cycle, India CTM/associate CTM will visit to the site for administrative support for device operation, if other FMTs are not available due to the schedule conflict. In such cases, India CTM/associate CTM will support the site for documentations of PIT related record.
India CTM/associate CTM will be provided sufficient device training by RM FMT.
In addition, India CTM/associate CTM may be required to represent the company at medical conference and support to expand clinical network in India.
Desired Education, Skills and Experience
- Bachelor’s degree in scientific, Health or any life science field with at least 5 years of experience in clinical development of which at least 2 years of experience as clinical research associate
- Demonstrated high level of end user computer skills (MS Office applications, work, excel, PowerPoint etc)
- Good communication skills and command over English language both written and spoken skills.
- Experience with clinical trial processes, verbal reasoning, attention to details, critical thinking and analytical ability.
- Able to work independently as well as part of team, able to take initiative and responsibility, following through and completing assigned tasks.
- Strong medical research background with demonstrated in depth knowledge of medical research processes.
- Ability to work well across culture and time zones.
- Willingness to travel as required.
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.