Roche Holdings Inc.
Clinical Site Manager
Roche Holdings Inc., Zionsville, Indiana, United States, 46077
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 Position
A 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.As Site Management, we are the interface between Roche Diagnostics Study Teams and the external clinical study sites/Roche Customers performing the studies. Through a collaborative and strong study site relationship, we ensure study/site compliance with applicable regulations and guidelines; affirming the integrity of the generated data and preserving the safety of patients. It is with this expertise and approach that Site Management facilitates successful clinical trials, which are essential to bringing Roche products to market.The OpportunityThe Clinical Site Manager is responsible for designing, planning, coordinating and conducting all activities involved in initiating, monitoring, and completing clinical research studies in the clinical study sites and delivering as appropriate other data generation methodologies. Work independently to ensure studies are delivered, recorded and reported in accordance with protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements.You will adhere to regulations, guidelines and standard operating procedures, and ensure ongoing audit/inspection readiness.
Validate product performance claims, supply data for critical Regulatory submissions, define the functional and clinical utility of our products, and obtain the opinions and input regarding our products from laboratories or customers.
You will implement Site Management activities for sponsored studies for assigned area of focus for registrational and/or non-registrational purposes through all study phases (start-up, conduct and close-out).
You will work in local and global study teams, including virtual teams and exhibit diversity and cultural awareness.
Build and maintain strong, collaborative relationships with cross-functional team members, relevant internal and external stakeholders, in meeting business goals and ensuring operational excellence.
This is a remote position.
Who You AreYou have a minimum of 3 years of experience.
You hold a Bachelor's degree scientific subject area or related field required, or equivalent combination of education and work experience, experience in a clinical laboratory, clinical lab study coordination is a plus.
You are experienced in CPHCS, and CTMS/eTMF as required
Relocation benefits are not available for this job posting.The expected salary range for this position based on the primary location of Arizona is insert $76,300 - 141,700. 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.BenefitsWho we are
At 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 Accommodations for Applicants.
A 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.As Site Management, we are the interface between Roche Diagnostics Study Teams and the external clinical study sites/Roche Customers performing the studies. Through a collaborative and strong study site relationship, we ensure study/site compliance with applicable regulations and guidelines; affirming the integrity of the generated data and preserving the safety of patients. It is with this expertise and approach that Site Management facilitates successful clinical trials, which are essential to bringing Roche products to market.The OpportunityThe Clinical Site Manager is responsible for designing, planning, coordinating and conducting all activities involved in initiating, monitoring, and completing clinical research studies in the clinical study sites and delivering as appropriate other data generation methodologies. Work independently to ensure studies are delivered, recorded and reported in accordance with protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements.You will adhere to regulations, guidelines and standard operating procedures, and ensure ongoing audit/inspection readiness.
Validate product performance claims, supply data for critical Regulatory submissions, define the functional and clinical utility of our products, and obtain the opinions and input regarding our products from laboratories or customers.
You will implement Site Management activities for sponsored studies for assigned area of focus for registrational and/or non-registrational purposes through all study phases (start-up, conduct and close-out).
You will work in local and global study teams, including virtual teams and exhibit diversity and cultural awareness.
Build and maintain strong, collaborative relationships with cross-functional team members, relevant internal and external stakeholders, in meeting business goals and ensuring operational excellence.
This is a remote position.
Who You AreYou have a minimum of 3 years of experience.
You hold a Bachelor's degree scientific subject area or related field required, or equivalent combination of education and work experience, experience in a clinical laboratory, clinical lab study coordination is a plus.
You are experienced in CPHCS, and CTMS/eTMF as required
Relocation benefits are not available for this job posting.The expected salary range for this position based on the primary location of Arizona is insert $76,300 - 141,700. 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.BenefitsWho we are
At 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 Accommodations for Applicants.