Clinical Research & Project Lead, Oncology - Remote US

Varian Medical Systems

Atlanta Georgia

United States

Scientific Research
(No Timezone Provided)

Together, we can beat cancer. At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions. If you want to be part of this important mission, we want to hear from you. The Varian/Noona Clinical Research & Project Lead is a critical role in the Global Evidence and Value Team, and it requires demonstration of a range of skills to be successful. This person will have a strong background in oncology, acute care, primary care, or critical care, and diagnostics (preferred). The Clinical Research & Project Lead will be responsible for 1) clinical research/project management including registration of trials and post-market studies (the US and the Outside US), 2) supporting scientific education and evidence-based publication generation, 3) acting as main contact and project manager to the customer and manage cancer study projects from planning throughout execution until development of new business opportunities. This includes: Seamlessly collaborating with team members, Managing multiple real-world evidence projects, Communicating with internal and external stakeholders, Adhering to relevant procedures, regulations, and ethical guidelines, Contributing to the growth of the department and its mission Supporting Varian’s goals. KEY RESPONSIBILITIES: Managing multiple RWE-generating research projects including: Client communications (e.g. meetings, minutes) Data collection (e.g. developing Case Report Forms, overseeing data quality checks) Deliverables (Protocol, reports, adverse event reports, budgets, D&H accounts) Ethics submissions and compliance will all relevant regulations/guidelines governing research Project Management activities: Subcontractor management; Timeline development and maintenance; and Budgets and invoicing Design and development of evidence generation models that leverage multiple datasets to help generate clinical and economic value proposition of oncology therapies Design protocols for execution, and communication of observational research and pharmacoeconomic analyses Organizing and building process for the maintenance of study information to facilitate team collaboration and for other needs (e.g. external audits) Demonstrating creative problem solving to help the team address the challenges associated with real-world evidence research Assisting in the solicitation of new projects/business (e.g. proposal writing) Preparing ad hoc reports/metrics for stakeholders (e.g. leadership, sponsor, CROs and other individuals/groups) Facilitate the compiling and dissemination of data findings to key audiences through publications and abstract submissions Collaborate on the preparation of abstracts, synopses, manuscripts, and reports describing results of statistical analysis Supporting evidence-based process to improvement RWE research management (e.g. speed up study activation, implementation, conduct, close out, and reporting) Pre-study responsibilities include Investigator and study site selection. Initiate and lead clinical protocol development and reviews to ensure that the appropriate endpoints and comparator methods are included and followed while working collaboratively directly with internal teams and external investigators. Startup responsibilities include but are not limited to site contracting, budget negotiation, ethics committee approvals, create site training materials, manage investigational product inventory and logistics, oversee site initiation visits schedule/deliverables/documentation, development of electronic case report forms (CRFs) and manuals. Ensure IRB submissions are complete and investigational products are appropriately labeled. Monitoring/closeout responsibilities include establishing a monitoring schedule for each assigned study to ensure the study is adequately resourced and procedures are optimized to ensure data is complete, accurate, and study staff adheres to the study protocol. Supervise clinical monitoring/closeout through the management of internal employees or via external contract monitors; serve as the Company interface with CROs (as applicable). Review and approve site visit reports (SIV, monitoring, and closeout) to ensure they are clear, concise, complete, and adhere to Company SOPs. Post enrollment responsibilities include ensuring clinical trial data is accurate and complete for statistical analysis, submission to regulatory authorities, and manuscript preparation. Experience using electronic documentation systems (EDC) and Clinical Trial Management Systems (CTMS). Qualifications: Masters degree in a relevant field (e.g., health economics, outcomes research, health services research, epidemiology, health economics, or related fields) 5+ years of relevant experience (consulting experience is welcome) in the pharmaceutical or biotechnology or medical device industry - ideally within an HEOR or RWE setting, including experience overseeing clinical trials and scientific communications Demonstrates an understanding of FDA regulatory requirements and ICH-GCP for both sponsor and clinical trial sites. Ability to deliver educational presentations and training to all clinical trial site. Experience in the conduct of clinical research, including planning, design, and execution of studies Knowledge of the US healthcare system and its changing needs for health data Experience in application of with Real World Evidence and HEOR for pharmaceuticals Experience using clinical trial databases, electronic data capture Proficient with Microsoft Office Suite: Word, PowerPoint, and Excel (highly proficient preferred). Self-starter, experienced leader, and able to work independently with minimal supervision. Demonstrates very high attention to detail, with an eye to following every required aspect of Clinical Trial Protocol and Company SOPs. Excellent organizational skills. Ability to manage numerous projects simultaneously #LI-OSS1 To ensure compliance with applicable legal requirements in the U.S., including the federal COVID-19 vaccination mandate, all U.S. employees must be fully vaccinated for COVID-19, subject to legally required and approved accommodations. Fighting cancer calls for big ideas. We envision a world without fear of cancer. Achieving this vision takes dedication and commitment from all of us, every single day. That's why we celebrate and value the distinctly beautiful and intersectional identities of each of our employees. We are a mirror of our patient-base, which allows us to innovate. Big ideas come from everywhere, and the best ideas are fostered by our unique individual experiences. At Varian, we encourage you to bring your whole self to work and believe your bold and authentic perspective will help to power more victories over cancer. #TogetherWeFight Privacy Statement

Clinical Research & Project Lead, Oncology - Remote US

Varian Medical Systems

Atlanta Georgia

United States

Scientific Research

(No Timezone Provided)

Together, we can beat cancer. At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions. If you want to be part of this important mission, we want to hear from you. The Varian/Noona Clinical Research & Project Lead is a critical role in the Global Evidence and Value Team, and it requires demonstration of a range of skills to be successful. This person will have a strong background in oncology, acute care, primary care, or critical care, and diagnostics (preferred). The Clinical Research & Project Lead will be responsible for 1) clinical research/project management including registration of trials and post-market studies (the US and the Outside US), 2) supporting scientific education and evidence-based publication generation, 3) acting as main contact and project manager to the customer and manage cancer study projects from planning throughout execution until development of new business opportunities. This includes: Seamlessly collaborating with team members, Managing multiple real-world evidence projects, Communicating with internal and external stakeholders, Adhering to relevant procedures, regulations, and ethical guidelines, Contributing to the growth of the department and its mission Supporting Varian’s goals. KEY RESPONSIBILITIES: Managing multiple RWE-generating research projects including: Client communications (e.g. meetings, minutes) Data collection (e.g. developing Case Report Forms, overseeing data quality checks) Deliverables (Protocol, reports, adverse event reports, budgets, D&H accounts) Ethics submissions and compliance will all relevant regulations/guidelines governing research Project Management activities: Subcontractor management; Timeline development and maintenance; and Budgets and invoicing Design and development of evidence generation models that leverage multiple datasets to help generate clinical and economic value proposition of oncology therapies Design protocols for execution, and communication of observational research and pharmacoeconomic analyses Organizing and building process for the maintenance of study information to facilitate team collaboration and for other needs (e.g. external audits) Demonstrating creative problem solving to help the team address the challenges associated with real-world evidence research Assisting in the solicitation of new projects/business (e.g. proposal writing) Preparing ad hoc reports/metrics for stakeholders (e.g. leadership, sponsor, CROs and other individuals/groups) Facilitate the compiling and dissemination of data findings to key audiences through publications and abstract submissions Collaborate on the preparation of abstracts, synopses, manuscripts, and reports describing results of statistical analysis Supporting evidence-based process to improvement RWE research management (e.g. speed up study activation, implementation, conduct, close out, and reporting) Pre-study responsibilities include Investigator and study site selection. Initiate and lead clinical protocol development and reviews to ensure that the appropriate endpoints and comparator methods are included and followed while working collaboratively directly with internal teams and external investigators. Startup responsibilities include but are not limited to site contracting, budget negotiation, ethics committee approvals, create site training materials, manage investigational product inventory and logistics, oversee site initiation visits schedule/deliverables/documentation, development of electronic case report forms (CRFs) and manuals. Ensure IRB submissions are complete and investigational products are appropriately labeled. Monitoring/closeout responsibilities include establishing a monitoring schedule for each assigned study to ensure the study is adequately resourced and procedures are optimized to ensure data is complete, accurate, and study staff adheres to the study protocol. Supervise clinical monitoring/closeout through the management of internal employees or via external contract monitors; serve as the Company interface with CROs (as applicable). Review and approve site visit reports (SIV, monitoring, and closeout) to ensure they are clear, concise, complete, and adhere to Company SOPs. Post enrollment responsibilities include ensuring clinical trial data is accurate and complete for statistical analysis, submission to regulatory authorities, and manuscript preparation. Experience using electronic documentation systems (EDC) and Clinical Trial Management Systems (CTMS). Qualifications: Masters degree in a relevant field (e.g., health economics, outcomes research, health services research, epidemiology, health economics, or related fields) 5+ years of relevant experience (consulting experience is welcome) in the pharmaceutical or biotechnology or medical device industry - ideally within an HEOR or RWE setting, including experience overseeing clinical trials and scientific communications Demonstrates an understanding of FDA regulatory requirements and ICH-GCP for both sponsor and clinical trial sites. Ability to deliver educational presentations and training to all clinical trial site. Experience in the conduct of clinical research, including planning, design, and execution of studies Knowledge of the US healthcare system and its changing needs for health data Experience in application of with Real World Evidence and HEOR for pharmaceuticals Experience using clinical trial databases, electronic data capture Proficient with Microsoft Office Suite: Word, PowerPoint, and Excel (highly proficient preferred). Self-starter, experienced leader, and able to work independently with minimal supervision. Demonstrates very high attention to detail, with an eye to following every required aspect of Clinical Trial Protocol and Company SOPs. Excellent organizational skills. Ability to manage numerous projects simultaneously #LI-OSS1 To ensure compliance with applicable legal requirements in the U.S., including the federal COVID-19 vaccination mandate, all U.S. employees must be fully vaccinated for COVID-19, subject to legally required and approved accommodations. Fighting cancer calls for big ideas. We envision a world without fear of cancer. Achieving this vision takes dedication and commitment from all of us, every single day. That's why we celebrate and value the distinctly beautiful and intersectional identities of each of our employees. We are a mirror of our patient-base, which allows us to innovate. Big ideas come from everywhere, and the best ideas are fostered by our unique individual experiences. At Varian, we encourage you to bring your whole self to work and believe your bold and authentic perspective will help to power more victories over cancer. #TogetherWeFight Privacy Statement