General Scope and Summary
The Clinical Data Management group within the Sage Therapeutics is responsible for ensuring the robust application of traditional and emerging clinical data management techniques and tools to support the development and execution of clinical development strategies that deliver medically-differentiated therapies that provide meaningful improvement to patients. Clinical Data Management personnel work closely with the medical science, clinical operations development and safety functions to ensure that Sage’s development programs and their component clinical studies meet high quality data management standards.
Roles and Responsibilities
- The Principal Manager in Clinical Data Management is expected to execute many of his/her responsibilities semi-independently, and to interact with vendors in support of CD work progress.
- The successful candidate will
- Leads Phase I – IV Data Management teams comprising internal and external data management resources. Manage multiple clinical trials data or multiple data management projects under aggressive timelines in a high quality and professional manner.
- Oversees Data Management vendors – review and approve all DM documentation; maintain all data management internal files, ensuring preparedness for regulatory inspections.
- Develops data management SOPs and processes.
- Oversees the design, creation and testing of clinical study databases.
- Primarily responsible for creating and adhering to Data Management timelines and budget.
- Reviews protocols for proper data capture including electronic Case Report Form design. Able to perform a thoroughly detailed review of eCRF data requirements.
- Regularly provides feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications.
- Oversees the design, creation and UAT Plan and testing of clinical study databases along with development of edit check specifications and manual data listings as required.
- Responsible for review of medical coding, block cleaning, database lock and freeze, and SAE reconciliation activities performed by external vendors.
- Reviews and approves all DM documentation; maintain all data management internal files, ensuring preparedness for regulatory inspections.
- Ability to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications.
- Functional representative on project teams, study teams, development teams including multi-disciplinary interactions by participating in/leading project meetings to ensure clear overview of progress, risks and mitigation strategies by all participants for all data management related deliverables.
Experience, Education and Specialized Knowledge and Skills
- BA/BS, preferably in the scientific/healthcare field.
- At least 4-7 years in Data Management for the pharmaceutical/biotechnology industry.
- Experience as lead DM of a Phase I-III studies required; ability to be primary DM representative with little oversight required.
- Understanding of ICH GCP as well as knowledge of industry practices and standards
- Fluency in English, both oral and written
- Written and oral communication and presentation skills
- Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, Project)
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun
- Excitement about the vision and mission of Sage.