An opportunity exists for an ambitious professional to be part of the clinical operations team in support of Xcovery. Xcovery is a biopharmaceutical company working to improve the lives of patients by discovering medicines to develop a pipeline of oncology therapies. This position offers the right candidate a significant opportunity for career development and growth.
The Clinical Quality Assurance Manager (CQAM) works closely with internal team members and vendors to ensure that clinical trials are conducted per study plans and are compliant with SOPs, ICH / GCP/ regulatory guidelines.
Primary Responsibilities include but are not limited to the following:
Create, implement, and uphold SOPs for the department of Clinical Operations
Track of quality management activities
Participate in team and management meetings
Ensure all company clinical trials are following the clinical study plans and protocol
Develop company-wide Quality Management System to include SOPs and vendor oversight plans.
Develop individual quality oversight plans for each clinical trial to ensure there are adequate controls and then test the strength of these controls
Oversee the quality scientific and medical design of the protocol
Assist with regulatory agency and ethics committee submissions and meetings
Track and manage vendor audits
Anticipate, prevent, and address protocol, regulatory, and/or GCP non-compliance issues, should they arise
Orchestrate quality oversight of all study activities and provides risk mitigation strategies and process improvement feedback to project leaders and senior management
Reviews external and internal documentation routinely to ensure completeness, consistency and adherence to applicable standardized operating procedures
Confirms clinical trial study reports against source data for data accuracy, integrity and consistency
Supports the clinical operations and medical teams by providing input and oversight to GCP related activities
Works with vendors to ensure they meet or exceed quality obligations. Creates and maintains a list of approved clinical vendors
Conduct Quality Control of eTMF quarterly
Supervise quality assurance of data management and data listing audits for the study report
Participate in audits and support regulatory inspections related to GCP
Education and Skills Requirements:
• BS/BA degree or equivalent (background in life sciences preferred). Advanced degree preferred. • 10 +yrs. of industry experience (biotech/pharma/ CRO) with at least 8 years of QA experience • Experience in NDA FDA inspections (sponsor and site) • Experience in quality management of global Phase III oncology trials • Strong understanding of ICH, GCP and relevant regulatory requirements • Strong operations and management skills with attention to detail • Excellent communication skills and proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project
Please submit your Resume/CV, salary history and cover letter
Xcovery is a biopharmaceutical company working to improve the lives of patients with cancer by discovering medicines to fight advanced tumors. Xcovery is developing a pipeline of oncology therapies to target a wide range of advanced tumors. Xcovery’s lead product, X-396, is a small molecule that inhibits anaplastic lymphoma kinase (ALK). X-396 is being investigated for the treatment of ALK positi...ve non-small cell lung cancer. The Company is currently enrolling patients in its Phase 2 and Phase 3 human clinical trials. Xcovery is also developing MET and PI3K/mTOR kinase inhibitors for advanced tumors.