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
- Comfortable in a fast-paced small development company environment
- Proficient in Microsoft Outlook, Word and Excel
Preferred Education and Experience:- High school degree and at least 5 years of related experience; or, a bachelor's degree in related discipline and at least 3 years of related experience
- Additional qualification or experience in PK sample management
- Knowledge of GxPs and familiarity with US and EU regulations
- Knowledge of drug development process
- Experience with Interactive Responses Technology (IRT) Systems and other databases
- Experience in Microsoft Office applications, Pivot charts, Lucid chart, Swimlane and Smartsheet
The pay range that the Company reasonably expects to pay for this headquarters-based position is $101,300 - $119,200; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
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Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
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