Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Responsible to develop and drive quality management system for monitoring across GCRDO functions to proactively assess, manage and mitigate quality risks for GCRDO organization in alignment with overall business goals and optimized operational models. Leverages analytics and other approaches to perform trend analysis of monitoring practices and systems and make enhancements. Leads inspection readiness, root cause analysis and response teams for internal audits and inspection by health authorities for monitoring processes and systems.
•Work in collaboration with Global Monitoring team, key stakeholders, and affiliates to devise and implement oversight strategy and mechanism/systems for Celgene affiliates that is consistent with the oversight principles and plans for GCRDO and GTMM
•Focuses on reviewing and continuous improvement of monitoring processes at Celgene. Identify opportunities to improve quality, compliance, and efficiency. Lead and initiate small cross-functional teams to leverage staff diversity of experience in implementation of new, more effective ways of working.
•Partners with the training group to develop, delivery and implementation of training for Celgene Field monitors and CRO-CRAs as appropriate. Promotes consistent communication and distribution of information and relevant process changes including updates to training curriculum.
•Partners with senior leadership in monitoring, GTMM and CIQM to develop and implement Quality management system for monitoring with a keen focus on creation of metrics, key quality and performance indicators. Analyze metrics and provide insights to regional and global monitoring performance. Lead audit and inspection readiness in the monitoring function and development of root cause analysis and CAPA in response to internal audits and inspection by health authority agencies
•Leverages analytics to perform trend analysis of monitoring information on in-house and outsourced studies to identify gaps in performance and quality. Evaluates the evolving clinical research operations environment and competitive landscape, generates ideas and recommendations, and participates in quality assurance activities that foster continuous improvement across clinical programs and processes.
•Develops and manages consistent practices / processes, plans, documentation systems and report templates to be utilized across programs and regions.
•Partners with other colleagues in GTMM for administration of SOPs/WPs which will facilitate execution & oversight of both in-house and outsourced clinical trials/programs compliant with ICH/GCP standards.
•Leads the implementation of large scale initiatives and/or organizational changes that affect the department.
•BA/BS/MS or advanced degree preferred but not required in other relevant scientific area.
•15+ year experience in monitoring
•Demonstrated experience with quality management of monitoring processes, root cause analysis, CAPA development/implementation, training, and use of analytics.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.