The Senior Director of Clinical Data Management will be a key member in the leadership team of Data Science Department and will be accountable for global delivery, integrity and quality of Sumitomo Dainippon Pharma Oncology's clinical data across portfolios. This role will serve as the in-house data management subject matter expert (SME) and will oversee the clinical data management team activities. This incumbent will also take strategic responsibility for oversight of Contract Research Organization (CRO) activities related to data management, including project management, vendor management, and coordination of internal reviews.
- Serves as a key leadership member at Data Science Department to define and implement data science strategy, including data capture, data standard, systems and process integration and governance, and cross functional collaboration strategy etc.
- Provides clinical data management oversight of the Company's clinical trials including: project management, vendor management, coordination of internal reviews, and approval of deliverables.
- Provides leadership of evolution and improvement of data processes, systems and organization in alignment with other development functions.
- Provides strategic support to the integration of modern data analytics into oncology drug and vaccine development including artificial intelligence (AI), machine learning (ML), and real world data (RWD) architects.
- Ensures data system compliance by following the established guidelines of national and international regulatory authorities.
- Ensures the clinical data management team to be accountable for and to deliver high-quality clinical data management input/output, including clinical database design and production, CRFs/eCRFs design, CCGs/eCCGs, Data Transfer Agreements (DTAs), Data Management Plans (DMPs) and data reconciliation and coding.
- Ensures clinical data within EDC and/or other database is of high quality to support data monitoring, interim analysis, and lock/unlock of clinical database activities.
- Performs close-out audit, as specified, for closing of study trial in EDC or other databases.
- Directs management and mentoring responsibilities for internal data management team members.
- Identifies and implements process and standards to improve the effectiveness and efficiency of the data management team.
- Plans, manages and oversees relevant budget control and CRO activities.
- Other duties as assigned.
PROFESSIONAL EXPERIENCE / QUALIFICATIONS:
- Bachelor’s Degree require, Master’s Degree preferred.
- At least 12 years of clinical data management experience in the pharmaceutical industry including at least 3 years of personnel management experience.
- Demonstrated proficiency managing the lifecycle of clinical data projects.
- Knowledge of and experience with EDC databases, CDASH/SDTM standards, medical terminology, medical coding dictionaries, and quality control processes.
- Familiarity with GCP, ICH and FDA requirements as applicable for Clinical Data Management.
- Experience with drug development in oncology required.
Job Location: Cambridge, MA
Equal Opportunity Employer
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