Oversee all clinical data management and statistical programming activities: provide functional expertise, leadership, and guidance to Alpine Immune Sciences (AIS) and third-party study-team members for all clinical trials within the AIS portfolio.
- Work with departmental and AIS leadership to establish strategic plans and objectives
- Help institute departmental methods, standards, and procedures for projects, programs, and people
- Represent CDM on cross-functional project teams and in interactions with functional departments including Program Management, Clinical Operations, Regulatory Affairs, Quality Assurance, etc.
- Help select and manage the performance of CROs and other outside vendors
- Develop and implement resourcing and strategic plans to ensure CDM deliverables are completed on-time, with a high degree of quality, and in accordance with corporate and regulatory requirements (SOPs, GCPs, etc.)
- Oversee functional and technical electronic data capture (EDC), clinical data management (CDM), and programming activities and staff (employees, contractors, and/or third parties)
- Guide development of CDM documents including but not limited to DMPs, CRFs and CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, and data review plans
- Direct data cleaning activities such as study team data reviews (listings, dry-run TFLs), SAE reconciliation, non-CRF data reconciliation
- Program or oversee the production of SAS non-system edit checks and/or SAS data listings and tables
- Assist in the preparation of investigator brochures, clinical study reports, clinical sections of regulatory filings, annual reports, etc.
- Research, evaluate, and direct departmental initiatives and new technologies/innovations as needed to improve CDM processes
Qualifications, Experience, and Desired Skills:
- BA/BS in life sciences or relevant field, and 10+ years CDM and 5+ years management experience
- Thorough knowledge of FDA regulations, ICH and GCP guidelines, database development, CDISC (CDASH, SDTM, ADaM) and Data Exchange standards, UAT, and medical coding
- Robust understanding of non-CRF data flow, transfer, and integration
- Required experience: managing vendors/CROs, SAS programming; R programming strongly preferred
- Preferred experience: NDA/BLA or other relevant regulatory submission(s), RTSM/IWRS and ePRO systems, proficiency with informatics tools such as Spotfire and Tableau
- Relevant therapeutic experience in oncology and inflammatory disease desired
- Strong organizational, time management, and resource-allocation skills with the ability to perform and prioritize multiple tasks and projects seamlessly with excellent attention to detail
- Excellent interpersonal skills with the ability to build relationships with AIS personnel at all levels of the organization, as well as external partners/vendors
- Flexible with excellent problem-solving and negotiation skills