ESSENTIAL DUTIES AND RESPONSIBILITIES :

• Responsible for all aspect of data management activities of Rigel sponsored studies including data system set up i.e. EDC, ePRO etc.
• Represents data management function on the clinical study team.
• Managing CRO data management deliverables for the outsourced study
• Leads the creation and maintenance of study Data Management Plan, Data Review Plan and other associated data management documents. plan
• Leads data review, data cleaning activities, and provide frequent data cleaning dashboardand leads activities required for interim and final database locks.
• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
• Create and maintains SOPs, process maps and templates and timelines to ensure all data management deliverables are timely and in high quality
• Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.

KNOWLEDGE AND SKILL REQUIREMENTS :

• BS/BA in a health-related, life science area or technology-related fields preferred.
• Preferred minimum 7 years or equivalence experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
• Proven track record of strong project management skills and experience managing data management activities for large drug development programs.
• Ability to use EDC system, and other digital tools
• Ability to handle multiple development programs simultaneously.
• Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
• Rigel requires all employees to be vaccinated against COVID-19 (subject to any legally required exemptions)

WORKING CONDITIONS:

• PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and the ability to adjust focus.
• WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required.

Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.