Sr. Clinical System Manager

2 months ago

South San Francisco, United States Genentech, Inc Full time

The mission of the Data Intelligence team in the Early Clinical Development (ECD) department at Genentech is to optimize the support of clinical systems to provide high-quality clinical trial data insights and to offer data science-related consultation to the study teams. We leverage cutting-edge data science and operation data management to facilitate the study start-up planning. We develop advanced analytical data visualization and conduct predictive analysis to increase the efficiency of clinical data review and clinical operations with the ultimate goal of driving data-driven decision-making throughout the study lifecycle.

The Opportunity: 

The role of the Sr. Clinical System Manager is responsible for driving the best practice and leading the support of clinical systems that are used in the development of the clinical trials in ECD (Early Clinical Development). The Sr. Clinical System Manager would work closely with key stakeholders and collaborate with colleagues in Roche/Genentech to streamline the process, identify synergies, and maximize 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. Your responsibilities may include: 

Set a vision for the clinical systems support activities, aligning with the ECDi Leadership Team (LT) to ensure it fits within the overall short-term and long-term technology and process roadmap across business units in Roche/Genentech

Accountable for guiding, planning, and implementing all related clinical systems (e.g., IxRS/IRT) actions for the 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 ensure the implementation and maintenance of technology solutions to support clinical trials

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

Provide strategic and operational leadership in system requirements gathering meetings with clinical study teams and clinical systems (e.g.,IxRS/IRT or other) vendor contacts

Lead the project management in all aspects, from specification, development, user acceptance testing, implementation, training, and 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 the study team and technology vendor project manager

Collaborate with colleagues across Roche/Genentech to simplify and streamline the process, identify the synergies, and ensure the best working practice within the team

Responsible for optimizing scope of work, resource allocation, and providing training and mentorship to team members


Who you are: 

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

6+ 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

Familiar with documentation in a regulated environment. Excellent documentation and communication skills

Preferred: 

Experience in Veeva is a plus

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

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