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Associate Director Data Manager
4 months ago
Associate Director/Director Data Manager serves as an expert for clinical data management, whether directly or by way of managing or mentoring contractor data managers. They will lead cross-functional team members to perform proper Data Reviews, and provides guidance on CDISC standards. This role will report to VP, Head of Data Science Solutions.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Responsible for leading data management activities.
- Responsible for vendor oversight activities across global development programs. Represents data management function on the clinical study team ensuring aligned expectations between the CRO and Sponsor for all data related deliverables.
- Works with other functions to complete set up of EDC and other study data collection tools such as IRT, ePRO.
- Leads the creation and maintenance of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, database lock plans.
- Leads data review, including query management, and leads activities required for interim and final database locks.
- Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
- Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models.
- 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 10 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 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.
