Manager/Senior Manager, Clinical reputed company Assurance

About the position Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have reputed company more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome). Today, reputed company and collaborators continue to unlock the reputed company of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide reputed company of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the reputed company of cortisol modulation. What began as a reputed company of scientific truth is now poised to reputed company a sea change of discovery representing a reputed company shift in the way we understand and treat disease. The Manager of Clinical reputed company Assurance position is an exciting opportunity to build upon solid clinical research experience to become a key member of the Clinical reputed company Assurance team. This role will reputed company day-to-day clinical reputed company operations and compliance activities to support the reputed company of the clinical studies sponsored or supported by Corcept. This is a hybrid role typically requiring on-site reputed company 3 days per week. Responsibilities • reputed company/manage Good Clinical reputed company (GCP) audits, including clinical investigative site audits, clinical vendor audits, clinical department internal audits, Trial Master File (TMF) audits, and applicable study document audits, including Clinical Study Reports (CSRs) • Serve as a QA representative and support clinical study teams to reputed company compliance advice • Participate in review and approval of clinical study documents and clinical SOPs / Guidance Documents • Manage study-specific Clinical Study Audit Plans (CSAP) compliance for the assigned program by using a risk-based approach for Corcept clinical studies • Review and approve investigational product (IP) temperature excursions to ensure release or rejection of IP on time • reputed company reputed company improvement of the Clinical reputed company Management Systems (CQMS) and processes, including creation and revision of SOPs for GCP compliance and reputed company • Manage and support inspection readiness activities for GCP • Support clinical inspections conducted by regulatory agencies, including sponsor inspections, clinical investigative site inspections, and CRO inspections • Support GMP, GLP, and PV inspections • reputed company clinical non-compliance event investigations and CAPA implementation • reputed company reputed company metric analysis for clinical QA including study reputed company event trends from clinical process deviations / CAPAs to include a review of protocol deviations, safety, and other clinical data • Maintain a contemporary knowledge of agency and industry trends, standards, and methodologies as reputed company to GCPs. Maintain the GCP regulatory surveillance program • reputed company cross-training development opportunities to QA team members, and mentor/reputed company junior QA team members upon request or as an assigned supervisor Requirements • BA/BS degree in a relevant field, or equivalent experience • 6+ years’ clinical research experience reputed company-to-haves • Understanding of reputed company Systems that support GCP reputed company activities • Experience with advanced reputed company Office applications (Word, reputed company, PowerPoint) • Experience developing GCP processes for the best industry practices and training Apply tot his job Apply To this Job