Praneeth Patlola
This listing was posted on Willhire.
Clinical Systems Leader
Location:
South San Francisco
Description:
<p>Job Title: Clinical System Lead (contractor)<br />Job Profile:<br /><br /><br />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.<br /><br /><br />Responsibilities:<br />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<br />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<br />Lead and facilitate system requirements gathering meetings with clinical study teams and IxRS/IRT or other clinical system vendor contacts<br />Lead and responsible for the project management in all aspects, from specification, development, user acceptance testing, implementation, training, amendments, to closeout<br />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<br /><br /><br /><br /><br /><br /><br />Qualification requirements:<br />Bachelor's Degree in life science, computer science, engineering, information system, data science or related discipline<br />7+ years of experience in clinical operations, clinical supply chain or clinical systems management<br />5+ years of IxRS/IRT and clinical related systems experience<br />Successful track records in leading the implementation of clinical systems, such as IxRS/IRT, ePRO and eCOA<br />Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution<br />Detail-oriented and able to manage many projects simultaneously. Good negotiation skills<br />Familiar with documentation in a regulated environment. Excellent documentation and communication skills<br />Meeting management and facilitation skills across multiple line functions. Solid vendor management experience.<br />Excellent project management and organization skills in a timeline-driven environment<br />Sound problem resolution, judgment, and decision-making abilities<br />Experience in Veeva is a plus</p><p><strong>Pay Range: $100 - $140/hour</strong></p><p>- health, dental, vision, 401k</p>
Visit Our Partner Website
This listing was posted on another website. Click here to open: Go to Willhire
Important Safety Tips
- Always meet the employer in person.
- Avoid sharing sensitive personal and financial information.
- Avoid employment offers that require a deposit or investment.
To learn more, visit the Safety Center or click here to report this listing.
More About this Listing: Clinical Systems Leader
Clinical Systems Leader is a Jobs Clinical Systems Leader Job at Roche and Genentech located in United States. Find other listings like Clinical Systems Leader by searching Oodle for Jobs Clinical Systems Leader Jobs.
Clinical Systems Leader is a Jobs Clinical Systems Leader Job at Roche and Genentech located in United States. Find other listings like Clinical Systems Leader by searching Oodle for Jobs Clinical Systems Leader Jobs.