Research Project and Regulatory Affairs Manager
Under the direction and supervision of the Chief Administrative Officer, Surgical & Cancer Research, this position is responsible for the management of multiple assigned clinical trials throughout all lifecycle phases. Ensures that all clinical trials are conducted according to sponsor expectations, ensuring quality data on time and within budget, and in accordance with SOPs, ICH GCP, applicable regulations, policies and practices. Serves as the principal liaison with sponsors to ensure effective and timely communication of clinical trial progress, issues, and plans for resolution of those issues. Provides leadership in the development of clinical trials and regulatory / IRB applications. Works closely and effectively with cross-functional teams.
Qualifications/Knowledge, Skills, & Abilities:
- Bachelor's Degree in clinical, scientific or business related discipline or any equivalent combination of education and experience preferred.
- Minimum of 8 years' experience in clinical research administration required with experience in clinical research administration involving FDA registration or industry sponsored trials preferred.
- Working knowledge of clinical research Electronic Data Capture (EDC) systems (i.e. iMedidata RAVE) and Clinical Trial Management System(s).
- Strong organizational and problem solving skills.
- Ability to multi-task.
- Promotes a spirit of teamwork through effective communication, cooperation, and collaboration.
- Demonstrates ability to work with self-direction and effectiveness under minimal supervision Communication and other skills:
- Excellent communication skills are required.
- Certain degree of creativity and latitude.
- Proficient in Microsoft Office including MS Word, Excel, and Powerpoint; MS Outlook and Internet Explorer.
- Must have the ability to work well with staff of all levels