The Senior Veeva Vault EDC Manager 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.
Develop, lead and manage clinical digital solutions data foundation activities for one or more global clinical programs.
Support integrated digital data solutions from source to submission to achieve successful outcomes and quality results.
Required to collaborate internally or with external entities and/or cross-functional team members to assure robust approaches are in place for all data foundation systems used in studies across one or more clinical programs.
Partners with CO&CDS colleagues on sub-processes such as imaging and standards/templates in the design of digital solutions; exhibits a general understanding of product development and enhancements
Transform technical ideas, thoughts, and discussions into written process documentation or How-Tos.
Provide project management for assigned efforts, including oversight with vendors (as required) on solutions or technology to ensure that the digital technologies are fully utilized in executing the agreed project plan.
Assist in deploying process changes and user adoption of the Veeva EDC, J-Review & SAS Clinical applications across the enterprise and data migration activities that support utilization of study data
Develop deep understanding of the business colleagues' digital systems challenges and CO&CDS needs.
Translate business challenges into actionable recommendations e.g. into maximizing system(s) utilization by facilitating the development of process materials/procedures to support the desired change.
Assist in identifying and defining process strategies for supporting end-of-study data migration activities for the transfer of study data from CROs/IMMU data repositories used for Clinical Research related activities such as EDC.
Work with the operational functions to troubleshoot issues, along with IT, for clinical digital tools such as Veeva EDC, J-Review, SAS and other software applications.
Help to develop core systems utilization metrics which help track major study milestones or monitor overall operational performance through the life of the study.
Act as department liaison with IT and operational CDS teams
Maintain a positive, results orientated work environment, building partnerships and modeling good teamwork as well as communicating in an open and objective manner.
Possesses the analytical ability to define problems and interpret the information to achieve consensus and make recommendations to clinical digital solution Directors for resolution and action.
Performs other duties and participates in projects for clinical systems as assigned with or without accommodation
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