Sr. Clinical System Manager

2 weeks ago

South San Francisco, United States Genentech Full time

The Position

We advance science so that we all have more time with the people we love 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

Relocation benefits are not available for this posting. The expected salary range for this position based on the primary location of South San Francisco, California is 156,700 and 291,100. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits 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.

#J-18808-Ljbffr

  • Clinical Systems Leader

    2 weeks ago

    South San Francisco, United States Avispa Full time

    Clinical Systems Leader ROCGJP00026006 A leading biotechnology company is seeking a Clinical Systems Leader. The successful candidate will be responsible for leading the support of clinical systems that are used in the development of the clinical trials in ECD (Early Clinical Development). The ideal candidate has 7+ years of experience in clinical...

  • Clinical Systems Leader

    1 month ago

    South San Francisco, United States Avispa Technology Full time

    Job DescriptionJob DescriptionClinical Systems Leader ROCGJP00026006 A leading biotechnology company is seeking a Clinical Systems Leader. The successful candidate will be responsible for leading the support of clinical systems that are used in the development of the clinical trials in ECD (Early Clinical Development). The ideal candidate has 7+ years of...

  • Clinical Development Manager

    2 weeks ago

    South San Francisco, United States Neurona Therapeutics Full time

    Neurona Therapeutics is a clinical stage biotechnology company based in South San Francisco focused on the development of neuronal cell-based therapies for intractable neurological diseases. Our ideal candidate is a self-motivated individual who has a passion for method development and qualification that can thrive in a fast-paced dynamic environment. The...

  • Clinical Development Manager

    2 weeks ago

    South San Francisco, United States Neurona Therapeutics Full time

    Neurona Therapeutics is a clinical stage biotechnology company based in South San Francisco focused on the development of neuronal cell-based therapies for intractable neurological diseases. Our ideal candidate is a self-motivated individual who has a passion for method development and qualification that can thrive in a fast-paced dynamic environment. The...

  • Sr. Clinical Product Quality Manager

    1 day ago

    San Diego, CA, United States CliniComp Full time

    DescriptionAre you passionate about ensuring the quality and effectiveness of clinical products? Do you have experience in healthcare IT and a strong understanding of clinical workflows? If so, we have an exciting opportunity for you as a Sr. Clinical Product Quality Manager at CliniComp.RequirementsIf you are seeking an exciting and fulfilling opportunity...

  • Contract - Clinical Systems Specialist

    1 week ago

    South San Francisco, United States Cytokinetics, Incorporated Full time

    Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of...

  • Contract - Clinical Systems Specialist

    2 weeks ago

    South San Francisco, United States Cytokinetics Full time

    Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of...

  • Contract - Clinical Systems Specialist

    2 weeks ago

    South San Francisco, United States Cytokinetics Full time

    Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of...

  • Sr. Clinical Product Quality Manager

    2 weeks ago

    San Diego, United States CliniComp Full time

    Are you passionate about ensuring the quality and effectiveness of clinical products? Do you have experience in healthcare IT and a strong understanding of clinical workflows? If so, we have an exciting opportunity for you as a Sr. Clinical Product Quality Manager at CliniComp.

  • Director, Clinical Quality Assurance

    7 days ago

    South San Francisco, United States Alumis Inc. Full time

    Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.   Alumis is hiring a Clinical Quality Assurance...

  • Director, Clinical Quality Assurance

    1 week ago

    South San Francisco, California, United States Alumis Inc. Full time

    Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.Alumis is hiring a Clinical Quality Assurance...

  • Director, Clinical Quality Assurance

    3 weeks ago

    South San Francisco, California, United States Alumis Inc. Full time

    Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.Alumis is hiring a Clinical Quality Assurance...

  • Clinical Manager

    1 week ago

    South Bend, United States Pulse Clinical Alliance Full time

    Job DescriptionJob DescriptionPulse Clinical Alliance is hiring a Clinical Manager in South Bend, IN.Job Details:Full-time positionPay Rate: $74,880 a year - $5,000 sign-on bonusShift: Days/Evenings - 40hrs/weekExperience: 2 years preferredRequirements:License in LMFT, LCSW, or LMHCComputer, Phone, and Documentation skillsDescription:These are court-mandated...

  • Clinical Manager

    5 days ago

    South Bend, United States Pulse Clinical Alliance Full time

    Pulse Clinical Alliance is hiring a Clinical Manager in South Bend, IN. Job Details:Full-time positionPay Rate: $74,880 a year - $5,000 sign-on bonusShift: Days/Evenings - 40hrs/weekExperience: 2 years preferredRequirements:License in LMFT, LCSW, or LMHCComputer, Phone, and Documentation skillsDescription:These are court-mandated services for children who...

  • Clinical Manager

    6 days ago

    South Bend, United States Pulse Clinical Alliance Full time

    Pulse Clinical Alliance is hiring a Clinical Manager in South Bend, IN. Job Details:Full-time positionPay Rate: $74,880 a year - $5,000 sign-on bonusShift: Days/Evenings - 40hrs/weekExperience: 2 years preferredRequirements:License in LMFT, LCSW, or LMHCComputer, Phone, and Documentation skillsDescription:These are court-mandated services for children who...

  • Clinical Manager

    2 days ago

    South Bend, United States Pulse Clinical Alliance Full time

    Pulse Clinical Alliance is hiring a Clinical Manager in South Bend, IN. Job Details:Full-time positionPay Rate: $74,880 a year - $5,000 sign-on bonusShift: Days/Evenings - 40hrs/weekExperience: 2 years preferredRequirements:License in LMFT, LCSW, or LMHCComputer, Phone, and Documentation skillsDescription:These are court-mandated services for children who...

  • Senior Clinical Trial Associate

    2 weeks ago

    South San Francisco, United States Alumis Inc. Full time

    Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. As a Sr. CTA, you will work closely with the...

  • Director, Clinical Quality Assurance

    3 weeks ago

    South San Francisco, United States Alumis Full time

    Job DescriptionJob DescriptionSalary: Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. Alumis is...

  • Senior Clinical Trial Associate

    1 month ago

    South San Francisco, United States Alumis Inc. Full time

    Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients. As a Sr. CTA, you will work closely with the...

  • Sr. Manager, Systems Engineering

    4 weeks ago

    San Carlos, United States Noah Medical Full time

    About The Team: The Systems Engineering Manager will be responsible for leading the systems engineering team dedicated to translating customer requirements into detailed product requirements and following through all design control phases of the product. The Systems Engineering Manager will also manage risk assessment and traceability of system level...