Clinical Systems Leader W2 ONLY

W2 Only

HYBRID IN SOUTH SAN FRANCISCO

The role of the Clinical System Lead is responsible for leading the support of clinical systems that are used in the development of the clinical trials in ECD (Early Clinical Development). The Clinical System Lead would work closely with key stakeholders and collaborate with colleagues in Roche/Genentech to streamline the process, identify the synergies, and maximize the efficiency. This could involve leading IxRS (Interactive Voice / Web Recognition System) or IRT (Interactive Response Technology) which entails specifying and/or building, providing and/or supporting clinical trial-specific systems to manage the clinical supplies to clinical study investigational sites.

Responsibilities:
Responsible for guiding, planning, and implementing all IxRS/IRT actions for ECD portfolio. Work with a cross-functional team of internal stakeholders (including but not limited to: Clinical Study Lead, Biostatistician, Drug Supply Chain, Data Management functions, and Procurement) and technology vendors to support the implementation and maintenance of interactive response technology solutions to support clinical trials

Provide technical oversight to ensure that IxRS/IRT or other clinical system solutions adhere to the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines

Lead and facilitate system requirements gathering meetings with clinical study teams and IxRS/IRT or other clinical system vendor contacts
Lead and responsible for the project management in all aspects, from specification, development, user acceptance testing, implementation, training, amendments, to closeout
Closely manage project-related timelines and associated activities. Proactively identify and track portfolio/study-related technical issues to resolution. Document issues and risks, and implement mitigation plans in partnership with study team and technology vendor project manager
Qualification requirements: Bachelor's Degree in life science, computer science, engineering, information system, data science or related discipline 7+ years of experience in clinical operations, clinical supply chain or clinical systems management 5+ years of IxRS/IRT and clinical related systems experience Successful track records in leading the implementation of clinical systems, such as IxRS/IRT, ePRO and eCOA
Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution
Detail-oriented and able to manage many projects simultaneously. Good negotiation skills
Familiar with documentation in a regulated environment. Excellent documentation and communication skills
Meeting management and facilitation skills across multiple line functions. Solid vendor management experience.
Excellent project management and organization skills in a timeline-driven environment
Sound problem resolution, judgment, and decision-making abilities
Experience in Veeva is a plus