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 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 preferred, 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 and manage 1-3 clinical studies

Desired Education, Skills and Experience

• 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, MS Project or other timeline management tool, Outlook) and Adobe Acrobat programs
• Ability and willingness to travel at times up to 20% nationally and internationally, depending on trial activities