The Associate Director, Clinical Digital Solutions (EDC)– primarily supports Clinical Operations & Clinical Data Sciences (CO&CDS). Position is responsible for data foundation activities such as: data linkages and visualization of the Immunomedics (IMMU) clinical data; building a secure formatted data repository and utilizing other digital tools in the operational delivery of clinical study trials. The candidate is expected to have broad business systems knowledge and experience in supporting clinical EDC, clinical data sciences planning, oversight and execution of complex global studies across multiple-phases of clinical trials (I – III). As a Subject Matter Expert (SME) for Clinical Digital Solutions, this role includes three primary accountabilities. First, supporting innovation and continuous improvement of digital solutions across the organization by creating awareness of the usage of digital systems in clinical processes. Second, leveraging clinical digital solutions to achieve higher efficiencies and standards that improve cross-functional team collaboration and coordination of operational approaches for delivering studies. And third, provide oversight or management of interactions with CROs and other digital systems vendors to ensure studies are conducted on time, of good quality and within budget. Works collaboratively with Clinical Digital Solutions and with IT in support of clinical and related enterprise digital solutions.
Bachelor’s Degree in Engineering or Sciences preferred. Good sound pharmaceutical industry business experience desired.
• At least 10 years of clinical digital data foundation experience with a Biotechnology/Pharmaceutical company or CRO in conducting Phase I - IV multinational clinical studies. Advanced degree in scientific, clinical research or regulatory affairs, or data foundation is desirable or equivalent by experience or technical training
• 5 plus years of cross-functional team Project Management experience. PMP or equivalent other certification e.g. LEAN Six-Sigma methodology
• Experience creating status reports, including building KPIs,d dashboards and data vizualization capabilities for use in study teams is desirable
• Solid understanding of US and Global regulations and guidelines applicable to clinical development, inspection readiness and system validation
• Able to solve complex digital technology problems with minimal or no direct supervision