88-50100922 Senior Clinical Operations Lead
Apply NowCompany: Roche
Location: South San Francisco, CA 94080
Description:
The Position
Genentech, Inc. seeks a Senior Clinical Operations Lead at its South San Francisco, CA location.
Duties: Provide scientific expertise and guidance on pharmaceutical development, disease characteristics, regulatory inspections of clinical study sites, quality and compliance reviews, and internal audits. Lead teams and participate in the preparation of clinical studies with respect to feasibility, site selection, and study initiation ensuring resources are available within clinical operations. Assess, measure and mitigate issues related to the development of pharmaceuticals such as clinical trial data sharing with hospitals and accuracy of results. Lead local study teams at the country and site level in terms of time, quality, and cost; represent country/regional clinical operations for the development of pharmaceuticals at the global study team level. Develop clinical trials patient recruitment protocols. Identify areas of best practice and implement activities to improve and maintain quality and effectiveness of pharmaceutical clinical trials. Serve as a key point of contact for clinical studies on behalf of stakeholders including investigators, local medical team, global study team, head of clinical operations, therapeutic area leader, country medical director and medical managers. Supervise up to 10-13 Clinical Operations Leads. Telecommuting permitted up to 2 days per week.
Education and experience required: Bachelor's degree in Biological Sciences, Genetics, Clinical Science, Oncology, or related field and 3 years of progressive, post-baccalaureate experience as Clinical Study or Operations Lead, Study Manager, Study Start-Up Manager, Clinical Research Coordinator, or related role.
Special Requirements: Must have the following skills:
The expected salary range for this position based on the primary location for this position of California is $218,904 to $284,100 per year. Actual pay within the range 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 (https://roche.ehr.com/default.ashx?CLASSNAME=splash)
Worksite: 1 DNA Way, South San Francisco, CA 94080
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Genentech, Inc. seeks a Senior Clinical Operations Lead at its South San Francisco, CA location.
Duties: Provide scientific expertise and guidance on pharmaceutical development, disease characteristics, regulatory inspections of clinical study sites, quality and compliance reviews, and internal audits. Lead teams and participate in the preparation of clinical studies with respect to feasibility, site selection, and study initiation ensuring resources are available within clinical operations. Assess, measure and mitigate issues related to the development of pharmaceuticals such as clinical trial data sharing with hospitals and accuracy of results. Lead local study teams at the country and site level in terms of time, quality, and cost; represent country/regional clinical operations for the development of pharmaceuticals at the global study team level. Develop clinical trials patient recruitment protocols. Identify areas of best practice and implement activities to improve and maintain quality and effectiveness of pharmaceutical clinical trials. Serve as a key point of contact for clinical studies on behalf of stakeholders including investigators, local medical team, global study team, head of clinical operations, therapeutic area leader, country medical director and medical managers. Supervise up to 10-13 Clinical Operations Leads. Telecommuting permitted up to 2 days per week.
Education and experience required: Bachelor's degree in Biological Sciences, Genetics, Clinical Science, Oncology, or related field and 3 years of progressive, post-baccalaureate experience as Clinical Study or Operations Lead, Study Manager, Study Start-Up Manager, Clinical Research Coordinator, or related role.
Special Requirements: Must have the following skills:
- clinical trial management from start-up through closeout, including management of vendors, clinical trial agreements and budgets, clinical site training and oversight, data collection and review, inspection readiness, and use of clinical trial management systems
- execution of clinical trials/studies including site, country, and global level
- application of knowledge of oncology drug research and development
- internal and external stakeholder management
- understanding and interpreting global and U.S. clinical regulatory guidelines
- application of biomarker knowledge through academic, industry or scientific publication experience
- creation and review of SOPs and trial documents including ICFs, protocols and training materials, CRFs and validation guidelines, and communication plans
The expected salary range for this position based on the primary location for this position of California is $218,904 to $284,100 per year. Actual pay within the range 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 (https://roche.ehr.com/default.ashx?CLASSNAME=splash)
Worksite: 1 DNA Way, South San Francisco, CA 94080
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.