Clinical Site Manager (Systems and Automation) job opportunity at Roche.

Home Jobs In United States Of America Tag: Job Clinical Site Manager (Systems and Automation) position at Roche


DatePosted Yesterday bot
Roche Clinical Site Manager (Systems and Automation)
Experience: 3-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Job

Copy Link Report
degreeOND
loacation Pleasanton, United States Of America
loacation Pleasanton....United States Of America

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position As a Clinical Site Manager for the Study Delivery CVMD Core Lab SWA Systems & Automation team, you are designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies in the clinical study sites. You are delivering other data generation methodologies, working independently to ensure studies are delivered, recorded, and reported in accordance with protocol, standard operating procedures, good clinical practices, and other applicable regulatory requirements. The Opportunity This position's main location is Pleaseanton, but people from any part of the US are encouraged to apply. Acting as the primary contact and clinical trial expert for assigned study site personnel, coordinating training, certification, and providing technical assistance to ensure successful study execution. Performing site assessments and qualification visits to support the site selection decision process and site activation activities, including contracting and obtaining IRB/EC/Health Authority approvals in compliance with regulatory requirements. Developing and managing key study site documentation, such as Study Monitoring Plans, informed consent documents, source documents, patient instruction guides, and case report forms, while contributing technical expertise to review study protocols, data management plans, reports, and manuscripts. Participating in and overseeing CRO delivery of site management activities, including training CRO CRAs, escalating issues, and collaborating with international investigators and key customers while mentoring and supporting colleagues to enhance their skills and expertise. Validating product performance claims, supplying data for critical regulatory submissions, defining the functional and clinical utility of products, and gathering feedback and opinions from laboratories or customers regarding the products. Executing site management activities for sponsored studies in assigned focus areas across all phases of study (start-up, conduct, and close-out) for both registrational and non-registrational purposes. Working in local and global study teams, including virtual teams, demonstrating diversity, cultural awareness, and fostering strong, collaborative relationships with cross-functional team members, internal stakeholders, and external partners to achieve business goals and ensure operational excellence. Who You Are You bring a Bachelor's degree in Science Degree preferably in Health Sciences like Clinical Diagnostics or engineering (or equivalent combination of  education and work experience) You have 3 years of working experience in either the Medical Device or Diagnostics industry, and 2 years of working experience in clinical study of IVD/Medical Device/Drug. Excellent understanding of ICH GCP guidelines in the execution of clinical trials Behaviors, competencies, and qualities of the ideal applicant. Exhibits the ability to make sound decisions and to analyze and solve problems; makes  independent choices and takes responsibility Demonstrates flexibility and adaptability to perform in a fast-paced, matrixed environment where fluid, cross-team collaboration is crucial. Relocation benefits are not offered for this position. The expected salary range for this position based on the primary location of California is 90,900 - 150,480 USD annually.  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. Benefits     Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Pleasanton. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process. Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche 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 .

Other Ai Matches

Alternant - Ventes à Distance en Biologie Moléculaire (f/m/d) Applicants are expected to have a solid experience in handling Job related tasks
Disease Area Squad Lead Hemophilia Applicants are expected to have a solid experience in handling Job related tasks
Regulatory Affairs Specialist Applicants are expected to have a solid experience in handling Job related tasks
HR Business Partner (Advisory) - Portuguese Applicants are expected to have a solid experience in handling Job related tasks
Travel & Expense Compliance Intern Applicants are expected to have a solid experience in handling Job related tasks
Specjalista/-ka ds. Serwisu Technicznego (Service Engineer) Applicants are expected to have a solid experience in handling Job related tasks
Alternant - Marketing Omnicanal (f/m/d)  Applicants are expected to have a solid experience in handling Job related tasks
Quality Assurance Manager Qualified Person Applicants are expected to have a solid experience in handling Job related tasks
AI & Data Science Intern Applicants are expected to have a solid experience in handling Job related tasks
Business Analysis Manager (Manufacturing IT System) Applicants are expected to have a solid experience in handling Job related tasks
Sr Manufacturing Engineer - Controls Applicants are expected to have a solid experience in handling Job related tasks
Account Executive - Molecular Diagnostics - AL, MS, Pensacola Applicants are expected to have a solid experience in handling MS, Pensacola related tasks
Patient Journey Partner, Quebec Applicants are expected to have a solid experience in handling Quebec related tasks
Intern - Marketing Applicants are expected to have a solid experience in handling Job related tasks
Internship in the field of bioconjugation (m/f/d) Applicants are expected to have a solid experience in handling Job related tasks
Network Service Delivery Lead Applicants are expected to have a solid experience in handling Job related tasks
ITOT Engineer Intern Applicants are expected to have a solid experience in handling Job related tasks
Engineer Post - Market Quality (PMQ) Applicants are expected to have a solid experience in handling Job related tasks
Teamlead Filling & Lyo Large Scale 2 (m/w/d) Applicants are expected to have a solid experience in handling Job related tasks
Patient Journey Partner Applicants are expected to have a solid experience in handling Job related tasks
Cost Accounting SME (ASPIRE project: S/4Hana Implementation) - Fixed term Applicants are expected to have a solid experience in handling Job related tasks
Expert, Manufacturing OE& BPM 专家, 生产精益运营与业务流程管理 Applicants are expected to have a solid experience in handling Manufacturing OE& BPM 专家, 生产精益运营与业务流程管理 related tasks
Section Lead Process Science and Data Flow Applicants are expected to have a solid experience in handling Job related tasks