Lead Clinical Site Manager

Company: Disability Solutions
Location: Tucson
Posted on: September 1, 2024

Job Description:

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.The PositionA healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.Diagnostics are an integral part of decision-making along every step of a person's health, wellness and disease journey. A diagnostic test alone can help clinicians change the course of someone's healthcare experience - and their life. We are a healthcare pioneer and the industry's global leader in in-vitro diagnostics, our Diagnostics Division pushes boundaries and challenges the status quo to redefine what's possible. Our commitment to research and development means we can bring to the market integrated solutions in diagnostic testing, laboratory efficiency, healthcare digitalization and decision support tools and software. Our products deliver increasingly precise information to help save lives, prevent or control the risk of infection and monitor treatment effectiveness. The Opportunity As a Lead Clinical Site Manager, you are responsible for the conception, planning, coordination, and execution of all activities related to the initiation, monitoring, and completion of clinical research studies at clinical trial sites. You will serve as the Site Management "functional subject matter expert" for a specific complex program of studies crossing countries/regions and project leaders. You also support other methods of data generation as needed. In this position, you will work independently and ensure that studies are conducted, recorded, and reported in accordance with the study plan, standard operating procedures, clinical practice, and other applicable regulations. --- You will collaborate with CDMA Global Study Managers to establish globalinvestigational site related strategies/scenarios, deliverables, timelines and required resources for the study.--- You will coordinate a team of Clinical Research Associates (CRA), in a matrix, within relevant data generation activities, studies, therapeutic areas / programs to ensure resource planning and on-time delivery of all Site Management activities in accordance with the protocol, standard operating procedures, good clinical practicesand other applicable regulatory requirements.--- You will assure that assigned CRAs are trained, coached, empowered and accountable to deliver all Site Management activities, within the portfolio of studies or related data generation activities, on time and with adequate quality with minimal oversight of a Subchapter Lead, Site Management.--- You will contribute to the establishment and further development of best practices and thought leadership for all aspects pertaining to clinical trial execution / site management / study monitoring; exemplify the principle of proactive and continuous improvement.Who You Are--- Bachelor's Degree in scientific subject area or related field required, or equivalent combination of education and work experience.--- 5+ years of experience in clinical laboratory or clinical research operations, or performing or overseeing clinical/technical studies, or project management, or equivalent combination of education and work experience--- 2+ years of experience in diagnostics specific to CDx/PHCS--- Presents a leadership mentality and the ability to engage with senior level and global audiences in a matrix organization.--- Knowledge of applicable standards and regulations for clinical trials and lab conduct [International Conference of Harmonization Good Clinical Practice standards (ICH-GCP), FDA Regulations, and IVDR]--- Strong track record of building and coaching capabilities such as Clinical Research Associates, clinical trial and site management personnel.--- Demonstrates courage, vision and drive to be at the forefront of innovative changeRelocation benefits are not available for this job posting.The expected salary range for this position based on the primary location of Tucson, AZ is $88,400 -$164,200. 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.Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form .

Keywords: Disability Solutions, Tucson , Lead Clinical Site Manager, Executive , Tucson, Arizona