Senior Manager, Clinical Data Management

Senior Manager, Clinical Data ManagementFor 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.The Sr Manager, Clinical Data Management, ensures optimized data collection, flow, and access across EDC and non-EDC data sources. Responsible for accuracy, completeness, and CDISC compliance of Corcept clinical databases.Responsibilities:Provides input into the design of data flow across EDC and non-EDC data sources across vendor networkManages data management service providers to ensure the quality of deliverables and that timelines are metDevelops and contributes to the design of processes enabling near-real-time data access for Corcept clinical trialsEnsure data quality of clinical database through the implementation of CDISC complianceReviews and critically assesses data query resolution metrics and suggests process improvementReviews study protocols to ensure that data collection and CRF design meet study objectivesManages and oversees SAE and external vendor reconciliation between clinical and applicable databasesReview clinical data for completeness, accuracy, and consistency in accordance with the investigational planProvide subject matter expertise to project team members during all phases of the project life cycleProvides accurate and timely clinical data to internal and external customers upon requestManage development, test, and maintain data management systemsSupport the development and periodic review of Data Management specific SOPs, WIs, and templatesProvide subject matter expertise prior, during, and post internal and external audits and inspectionsMaintain compliance with company and study-specific learning requirementsPreferred Skills, Qualifications, or Technical Proficiencies:Relational database experience, SAS, and clinical data management systemsKnowledge of CDISC/SDTM. Hands-on experience preferredHands-on experience working with mainstream EDC systems (e.g. Rave, Medrio)Familiarity with Data Visualization Tools for quick customized data access (e.g. Tableau, RShiny) a plusIn-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11Demonstrated strong management abilities for project and staff management of Data Management Deliverables in clinical developmentPreferred Education and Experience:Bachelor's or higher in science, math, or computer science5+ years' experience in data management in the clinical trial industry (med device, pharma, or biotech)Experience in IT-related fieldExperience with Oncology or rare disease clinical trials and CDISC therapeutic area standardsExperience with management of data flow and curation of biomarker dataExperience managing Data Management CROs and vendorsThe pay range that the Company reasonably expects to pay for this headquarters-based position is $170,550 – $200,700; 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.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.Corcept is an Equal Opportunity EmployerCorcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.