Associate Director, Clinical Data Management
Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE™ (fostamatinib disodium hexahydrate), an oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Rigel's current clinical programs include Phase 2 studies of fostamatinib in autoimmune hemolytic anemia and IgA nephropathy. In addition, Rigel has product candidates in development with partners BerGenBio AS, Daiichi Sankyo, and Aclaris Therapeutics.
The Associate Director, Clinical Data Management is responsible for taking a lead role in the planning, tracking, and oversight of clinical data acquisition and management activities, including managing vendors and coordinating resources to ensure efficient work flow. The Associate Director of Clinical Data Management responsibilities include building and enforcing the appropriate standards in the department and will enable collection, integration and aggregation of clinical data from investigational sites, external vendors, and other relevant data sources in accordance with industry standards and regulatory requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Oversees the work on projects to ensure on-time, on-target and within-budget results
- Acts as a liaison between statistical programming, biostatistics, clinical operations, subcommittees, and project teams as needed
- Leads the development and timely delivery of electronic Case Report Forms (eCRFs) for collection of clinical trial data from investigational sites that are designed in accordance with documented specifications, as well as industry and Rigel standards
- Establishes and maintains documented secure methods for data transfer from external vendors and ensures a standardized approach is defined with preferred vendors
- Collects, integrates and aggregates clinical trial data from multiple sources to facilitate ease of data review, reporting, and analysis
- Responsible for the creation and maintenance of standards including SOPs, CRFs/Global Libraries, and data structures and formats that adhere to industry standards and applicable regulations
- Leads the creation and review of CDM documents including Data Management Plans, Data Validation Specifications, SOPs/Work Instructions, and other applicable documents, as required
- Interacts with Statisticians, Statistical Programmers, and other clinical teams; perform ad hoc analysis and generate outputs in support of operational or regulatory requests
- Provides additional expertise to facilitate the analysis of clinical trial data as it relates to protocol development, case report form design and data collection, review/cleaning, and extraction
- Ensures effective quality oversight and management of external partners (e.g. Functional Service Providers, CROs, technology providers, etc.) performing clinical data management services on behalf of Rigel.
- Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results – Acts independently to determine methods and procedures on new assignments
- Serve as an internal and external spokesperson for the organization, as needed
- Establish data review and cleaning operations for ongoing trials to identify and remediate study conduct or data quality and integrity issues – Coordinate operational resources across multiple geographies and vendors
KNOWLEDGE AND SKILL REQUIREMENTS:
- Must have expert knowledge of good clinical data management practices (GCDMP) in global clinical trials
- Expertise in the collection and management of complex clinical trial data
- Detailed knowledge regarding the use and management of CDM systems, especially EDC systems, is required – Experience with either Medidata Rave© or Oracle InForm© is highly desirable
- Detailed knowledge of CDISC and other applicable industry standards, regulations, and guidelines
- Experience in managing projects, vendors, people, and technology
- Minimum 10 years pharmaceutical/biotech clinical data management experience; minimum 3 years of supervisory or lead management experience
- Experience working with oncology and/or hematology trials as well as NDA submission experience is highly desirable
- Bachelor’s Degree in related field, or an equivalent combination of education and work experience
Rigel Pharmaceuticals Inc. is an Equal Opportunity Employer with a commitment to diversity.
All individuals are encouraged to apply.