Sr. Manager, Data Management Process Control and Knowledge Management
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases . Summary . Responsible and accountable for managing, directing and coordinating Process Control and Knowledge Management activities within DM Operations. Contributes to the strategy of Clinical Data Management group. Contribute to the implementation of enhanced quality systems and standards within Global Development with partner QA/GCP Compliance functions. Participate, as needed, in initiatives within Global Development. Support the improvement in quality within Data Management by proactively identifying and addressing areas of concerns to avoid downstream issues. Assist the Director, Data Management Operations to drive a quality, compliance and quality process improvement mindset within Data Management and neighboring functions . Job Duties . Establish a partner and customer-orientated DM Process Control and Knowledgement Management group . Lead/coordinate implementation of quality related process improvements within/across Data Management, particularly . 1 those coming out of long-term sustainability activities/actions or process/operational excellence initiatives, ensuring timely rollout of each, 2 SOPs/BGs and other Working Procedures/templates needed to succeed with each are in place, 3 training is taken by all effected personnel, and 4 processes are established to measure KQI/KPIs to monitor progress and success against quality improvement objectives. Take relevant corrective actions when KQI/KPIs indicate it is necessary. Leads and oversees all aspects of DM process control and knowledge management, provides strategic and technical leadership of the SME Network, and drives continual process improvement to acheive state-of-the-art/cutting edge data management . Provides strategy for data management education new terminology, approach, and context and training . Systematically sample/monitor adherence to SOPs and standards to ensure that DM processes are performed in compliance with applicable regulations, guidance, and Regeneron Quality Modules and Policies . summarize/report the findings, including any SOP deviations and escalation of issues to department management and GCP Compliance as appropriate . provide remediation support when necessary . Lead root cause investigations in Data Management in collaboration with or under the direction of partners in GCP Compliance when process breakdowns or compliance gaps occur. Conduct formal investigations of issues as they arise . Initiates and leads business process changes in the context of data management with the CPMO Procedures and Processes partners . Collaborates closely with Global Development functions, to ensure that process control and training packages are defined, measured, managed and used to improve efficiency and quality of clinical trial collection, analysis, reporting and submission . Responsible for the metrics and governance of functional/technical guidance and instructional documents across the full spectrum of Data Management . Drives the vision for process adherance and training documentation of training delivered by SMEs and other qualified instructors. Leads the establishment of training programs technical and professional skills for Clinical Data Management staff and ensure staff training is conducted and properly documented . Represents Data Management in cross functional process discussion to ensure core needs of the department are met with regard to role-based responsibilities and training . May lead and support clinical & non-clinical special projects . Participates in Health Authority inspections as required as DM Training lead and select DM processes . Ensures that each associate has an up to date training and development plan in place . May serve as lead for continuous improvement efforts cross-functionally . May provide Subject Matter Expert Support for select topics assigned . Adheres to procedures surrounding retention of data, records, and information for clinical studies . Requirements . Bachelor degree in Life Sciences, Mathematics, Computer Science, Medical Informatics or equivalent degree. Must have least 5 or more years of clinical data management operations or data management education experience and 10 or more years experience in biotechnology, pharmaceutical or health related industry. Previous oncology and/or ophthalmology experience a plus . Ideally 5 or more years' experience in process control roles with at least 10 years in Clinical Data Man-agement. Strong understanding of regulation and guidance for drug studies including . ICH guidelines on GCP E6, E2A and E8 and applicable regulatory requirements, specifically 21CFR sub-parts 50, 54, 56, 312 and 314 as well as the European Directives on GCP 2001/20/EC and 2005/28/EC . Proficiency with Medidata Rave a plus. Additionally, Microsoft Office applications . May manage up to 3+ direct reports and in a matrix environment. Strong coaching and training skills - team player. May report to Director or above . This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business . To all agencies . Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid . Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.