The Clinical Systems Administrator (Contract, 20 hours/week) will play a supporting role in the implementation, management and support of the Clinical Systems used by Corbus Clinical Operations. This person will work closely with Project Managers (PM), and Clinical Systems Administrator to gather requirements and report status. Familiarity with clinical trial operations is required.
· Focus on the clinical systems user access requests
· Manage user access through accounts, credentials, access control, permissions, monitoring and trials
· Act as liaison with Clinical Systems Administration and vendors to manage user access aspects of the implementation
· Maintain list of approved system users with their authentication and authorization levels and role assignment.
· Update systems and functionality to improve company capacity and productivity by maintaining, improving an MS Excel-based business Intelligence Program for ongoing oversight of access clinical systems
· Participate in system UAT testing prior to system go-live while, at a minimum, ensuring system owners have completed UAT prior to system go-live, if appropriate
· Minimum 2 years prior experience in biotechnology or pharmaceutical industry
· Prior experience with electronic data capture systems
· Knowledge of 21 CFR Part 11, EU Directive 95/46/EC, and other applicable regulations
· Strong communicator with ability to influence team members cross-departmentally
· Familiar with MS office, specially Excel Power Query, VBA
· Can be remote
Corbus is a close-knit team of more than 140 employees who are high-achievers, innovative, creative and, above all else, passionate about what we do. We hire for personality as well as for skill.
You must thrive in an entrepreneurial and autonomous environment where you will succeed based on your contribution and work ethic, not on your title or rank. At Corbus we take pride in our “family” atmosphere where each person’s contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach.
There is no place for politics or red tape here. Positive, team-oriented people work at Corbus and are rewarded with fun perks like weekly food deliveries to our kitchen, a monthly in-house massage therapist, company-paid classes with Title Boxing, and organized company activities and outings. Additionally, Corbus offers an attractive, comprehensive benefits package.
Corbus Pharmaceuticals Holdings, Inc. (NASDQ: CRBP) is a Phase 3 clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat inflammatory and fibrotic diseases by leveraging its industry leading pipeline of endocannabinoid system-targeting drug candidates. The Company's lead product candidate, Lenabasum, is a novel, synthetic, oral, selective cannabinoid receptor type 2 (CB2) agonist designed to resolve chronic inflammation and fibrotic processes. Lenabasum is currently being evaluated in systemic sclerosis, cystic fibrosis, dermatomyositis, and systemic lupus erythematosus.
Corbus licensed the exclusive worldwide rights to develop, manufacture and market drug candidates from more than 600 novel compounds targeting the endocannabinoid system from Jenrin Discovery LLC. The pipeline includes CRB-4001, a 2nd generation, peripherally-restricted, selective cannabinoid receptor type 1 (CB1) inverse agonist specifically designed to eliminate blood-brain barrier penetration and brain CB1 receptor occupancy that mediate the neuropsychiatric issues associated with first-generation CB1 inverse agonists. Potential indications for CRB-4001 include NASH, primary biliary cholangitis, idiopathic pulmonary fibrosis, radiation-induced pulmonary fibrosis, myocardial fibrosis after myocardial infarction and acute interstitial nephritis, among others. CRB-4001 is scheduled to enter a Phase 1 study in 2019 followed a National Institutes of Health (NIH)-funded first-in-patient Phase 2 study.
Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer