Associate Director, Investigator Initiated Trials
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Job Description
Associate Director managing Investigator Initiated Trials for BeOne, ensuring compliance with FDA regulations and supporting project management and review processes across multiple sites.
Responsibilities:
- Responsible for the effective management of all aspects of Investigator-initiated Trials (IITs) including implementation in multi-institutions and research settings in accordance with FDA regulations and Good Clinical Practice guidelines
- Assist with program management, including use of the BeOne contract system for creating and tracking contracts and report creation through the IIT portal
- Support the review process for medical affair studies
- Support IIT operations and project management, cross-functional collaborations, process improvement, and vendor management
- Act as the Medical Internal Review Committee (MIRC) lead
- Review submitted proposals and protocols, adjudicate revised proposals and protocols based on MIRC comments
- Communicate comments from and the final decision of the MIRC review to the investigator and BeOne field medical team
- Assist in study budget coordination with PI and BeOne
- Support monthly study status report(s) and maintaining updated study information in the IIT portal
- Interface with the Accounting Departments to manage POs, record and reconcile all payment information and invoices
Requirements:
- BA/BS Degree is required
- Advanced degree (MD/PharmD, MS) is preferred
- MD/PharmD with 4 + years of experience within the pharmaceutical industry, clinical research, a consulting and/or CRO
- Masters Degree with 6 + years of experience within the pharmaceutical industry, clinical research, a consulting and/or CRO
- Bachelors Degree with 8 + years of experience within the pharmaceutical industry, clinical research, a consulting and/or CRO
- Strong project management skills
- Ability to plan, prioritize, and execute multiple projects; ability to multitask and work both independently and within multi-disciplinary teams
Benefits:
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
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