Reporting to the Vice President of Clinical Science and Operations, Data Management Director will lead the data management strategy and implementation for our clinical-stage program, currently in phase 3 development.
The Data Management Director will have a demonstrated ability to oversee the data management activities across a single clinical program or group of related studies. They will also provide data management leadership and expertise to project and study teams (including CROs/vendors) and have solid knowledge of the end to end clinical research and data management processes. The Data Manager Director will be responsible for leading and managing data management components of project as well as study budgets and vendor performance.
Job Responsibilities Include
- Serving as Lead Data Manager for Geron clinical trials, manage CRO activities for all study data management activities including database design and in‐stream study data management.
- Representing the DM line function to both Clinical and Study teams.
- Managing timelines and deliverables to complete data management activities, including those performed by CROs.
- Organizing and overseeing the development of databases and electronic Case Report Forms (eCRF), translate requirements to database specifications; develop/review eCRF completion Guidelines as needed
- Conducting User Acceptance Testing (UAT) of databases, including edit checks and reporting.
- Leading the planning and requirements for study data cleaning.
- Ensuring coordination of data cleaning activities with other clinical line functions through a centralized team.
- Accommodating ad hoc data requests between clinical team members, study sites and vendors, to support data cleaning, data entry requirements, and exploratory data review.
- Managing external data transfer protocols and standards.
- Organizing 3rd party data transfers with clinical databases.
- Overseeing and help with identification and management of data entry errors, coordinate resolution via the CRO/CRA as appropriate.
- Managing Geron Data Standards and Data Dictionaries across clinical trials.
EDUCATION AND EXPERIENCE REQUIREMENTS
- B.S. degree in scientific or related field, MBA or MPH is preferred
- Minimum of 5 years as a Data Manager within Data Management or Clinical organization, preferably 10-12 years of progressive experience in clinical trials in a data management role including previous supervisory or leadership responsibility
- Oncology experience preferable.
- Prior experience serving as a Trial Data Manager for early phase clinical trials, experience working as Data Management line function representative to Clinical Study Team.
- Prior experience managing and interacting with CRO’s, including coordinating day to day study data management activities.
- Primary experience with Clinical Data Management System process in the context of late phase clinical trials
- Working knowledge of SDTM/CDISC standards, MedDRA, and other coding dictionaries
- Experience with warehousing platforms preferred along with integration of complicated datasets in STDM/CDISC‐compliant standards
- Experience with one or more data reporting platforms, such as SAS, R.
- Basic understanding of relational databases, and field mappings
- Knowledge of FDA, EMEA and ICH guidelines and regulations for data management
- BLA, or NDA or other filing experience
- Development of policies and SOPs and CRO oversight skills