Specialist II, BioAnalytical Systems Analyst - Corcept Therapeutics

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.

Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.

Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com .

This position, reporting to the Associate Director of Data Analytics and Systems Development, will assist and support global PK and BioAnalytical (BioA) operations, sample and vendor management, and logistics activities for the PK department.  This role is responsible for tracking PK/BioA samples at the investigaitonal site(s) (no sample left behind). This role will work cross funcitonally with the Clinical Operations department to oversee  logistics from the clinical sites to Central labs, from Central labs to BioA testing sites, and/or long term storage facility. Generating PK sample reports for each clinical program, coordinating with vendors, and attending vendor meetings, as applicable, are examples of cirtical duties of this position. This role will also support non-clinical PK logistics as needed.

Responsibilities:

• Track and coordinate clinical investigational PK site shipments to ensure timely deliveries while meeting quality and regulatory requirements
• Work cross-functionally with Clinical Operations to support all clinical programs that have PK sample management requirements
• Assist in the preparation and tracking of all global logistics of Reference Standards, and PK sample movements
• Collect and organize PK sample documents to support filing into Corcept’s electronic Trial Master File system
• Review and summarize PK sample temperature recorder data to ensure data are archived in a timely manner and saved to the proper TMF index
• Manage PK sample long term storage
• Assist in drafting or revising PK and sample management SOPs
• Communicate with external vendors and internal customers as needed
• Work cross functionally to achieve company goals

Preferred Skills, Qualifications and Technical Proficiencies:

• Excellent interpersonal, verbal and written communication skills are keen in this collaborative, dynamic environment
• Organizational skills and ability to prioritize effectively to deliver results within established timelines
• Strong attention to detail and proactive follow-up is highly desirable
• Ability to interpret a variety of instructions furnished in written or verbal format