General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible and accountable for Data Management activities that support development and future commercial projects worldwide. Participate as an active member of multi-disciplinary team(s) to plan and manage the Data Management tasks required for phase 1-4 studies. Drive the delivery of end-to-end study data quality and integrity from source through publication/submission to archiving. This position will report to the Director of Clinical Data Management.
Roles and Responsibilities
- Key liaison/Data Management lead to Phase I – IV Data Management teams comprising of internal and external Data Management/Data Science resources (DM, Statistical Programmers and Statisticians), Clinical Operations study teams, for the purpose of data management, system development and data cleaning activities across multiple studies.
- As a member of the Data Science group - Manage clinical study data or data management projects under aggressive timelines in a high quality and professional manner.
- Review protocols and identifies requirements for proper data capture including electronic Case Report Form design and processing of clinical data ensuring accuracy, consistency and completeness while adhering to SOPs and work guidelines as required.
- Designs or reviews creation and maintenance of all essential data management documentation including CRF specifications, eCRFs, annotated eCRF, eCRF completion guidelines, Data Management Plans (detailing complete data management processes throughout clinical studies), Data Review Guidelines, Data Entry Guidelines, Data Transfer specifications and laboratory data handling.
- Oversee 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.
- Review and approve 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/health care 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.
- Experience is CNS/Neurology preferred and experience with orphan indications will be favorably considered.
- Understands the scope and focus of clinical trials phase 1-4 and has a proven ability to perform the tasks, manage vendor resources and timelines.
- Possesses an in-depth understanding of regulatory guidelines e.g. ICH, GCDMP, 21 CFR Part 11 and their application to Data Management practice.
- Knowledge of and experience with MedDRA and WHODrug data dictionaries.
- Intermediate skills and knowledge in adhoc data reporting, data review listings and metrics reporting.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors with positive data management approach.
- Possesses strong written and verbal communication skills.
- Able to travel to off-site meetings or training seminars as needed.
- Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Advanced level proficiency with relational databases (EDC) systems and technologies (e.g. RAVE, Medrio, Phase Forward InForm, Oracle Clinical) and CDISC data standards are desirable.
- Developing Computer proficiency in MS Office products (e.g. Microsoft Project, Excel, MS Word).
- Ability to thrive in a fast-paced, entrepreneurial environment with busy, high-performing colleagues.
- Self-motivated with strong sense of accountability.
- Excellent judgment, critical thinking and problem solving skills.
- Maximum flexibility to adapt to changing program needs in real time.
- 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