Position Summary
Clinical Study Lead will manage assigned clinical study(ies) from study plan through study closure in coordination with study governance across clinical studies running in globally and locally. This is an excellent opportunity to join a rapidly growing company to advance novel cutting-edge anticancer therapies into registration studies and later commercialization.
The ideal candidate will have minimum 7 years of experience with clinical study management (including site and CRO/vendor management) with previous experience with oncology, combination drug-device studies preferred, and global Phase 2/Phase 3 clinical study experience. The candidate will have strong working knowledge of drug and/or medical device development process, GCP and ICH guidelines, and FDA regulations (preferred).
Key Duties and Responsibilities
- Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements (1-3 studies).
- Manage overall aspects of clinical studies from planning study through study closure, with adherence to stated goals, timelines, budgets, and applicable regulatory requirements.
- Accountable for explaining study plan, resource and budget to company decision body.
- Oversee performance of study team members in either a matrix management model and/or as direct reports on their management of study deliverables, and actively provide 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, e.g., protocols/amendments, informed consent templates, Communication/Risk Mitigation Plan, eCRF & CRF forms/completion guidelines and site reference manuals/instructions.
- Manage Investigational Product, drug and device.
- Oversee Co-Monitors to ensure site and vendor compliance together with Clinical Operations.
- 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.
- Attention to detail and ability to prioritize tasks to meet critical timelines.
- Able to collaborate effectively with the study team, cross-functional team members, and external partners.
Desired Education, Skills and Experience
- Bachelor’s degree or equivalent in the life sciences or related field
- Minimum 7 years related industry experience with international company (including CRO)
- Experience with global clinical studies
- Experience managing study timelines, vendor contracts and budgets.
- Previous experience with oncology and/or combination drug-device studies is preferred.
- Strong leadership and, organizational and project management skills, including ability to multitask and organize/track information.
- Strong working knowledge of the drug/device development process, GCP and ICH guidelines
- Detail-oriented and proactive recognition of issues as they arise with resolution and/or appropriate escalation to management as warranted.
- Excellent interpersonal, written, and verbal communication skills in Japanese and English
- Ability to work independently and in a team environment.
- Strong computer skills and high level of proficiency with Microsoft Office (e.g., Word, Excel,
PowerPoint, Outlook)
- Ability and willingness to travel to nationally and internationally, depending on study activities.
