Senior Clinical Research Associate job opportunity at BeOne Medicines.

Home Jobs In Germany Tag: Job Senior Clinical Research Associate position at BeOne Medicines


DateMore Than 30 Days Ago bot
BeOne Medicines Senior Clinical Research Associate
Experience: 5-years
Pattern: Remote
Country:
apply Apply Now
Salary:
Status:

Job

Copy Link Report
degreeAssociate
loacation Germany Remote, Germany
loacation Germany Remote....Germany

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. Region to cover:  Northern Germany. Ideal candidate will be located in  Hamburg, Bremen, or Berlin. General Description: CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs. CRA performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/onco-hematology clinical trials within the assigned country/region. May be assigned to CRA activities or start-up activities, depending on experience and project needs. CRA is responsible for collaborating closely with the Country and Regional Clinical Study Teams to ensure study timelines are adhered to and required quality standards are maintained. CRA identifies gaps and areas for improvement and propose CAPA. CRA supports start-up and provides local expertise. expertise. Essential Functions of the job: Complete appropriate therapeutic, protocol and clinical research training/CRA training to perform job duties. Gain experience in BeOne and study procedures by working with experienced clinical staff. Perform site selection and evaluation, supporting initial list of sites and recruitment targets. Provide protocol and related study training to assigned sites. Conduct onsite/remote pre-study, initiation, routine monitoring and closeout visits per monitoring plan and applicable SOPs. Conduct co-monitoring visits, if required. Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation, in accordance with ICH-GCP, BeOne standards and SOPs. Manage sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) and local regulatory requirements. Ensure inspection readiness of the study and sites Establish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical Operations. Collaborate with Country and Regional Clinical Study Managers and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.) Facilitate Study Compliance Visits (SCVs), site audits and/or inspections, as required Evaluate the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate. Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question status-quo and promote innovation. Mentor junior staff (Associate CRA and CRA). Act as the escalation point person for CRA(s) with site-related issues and concerns.  May review visits reports, following-up on issue resolution and communicating with the Country/Regional Clinical Study Manager on significant risk identified and action proposed.  May serve as subject matter expert for clinical operations, country regulations and monitoring-related activities.  Supervisory Responsibilities:   Mentor/Buddy for junior CRAs.  Acts as the escalation point person for CRAs with site-related issues and concerns.  May serve as subject matter expert for clinical operations and CRA-related activities; Education Required: BS in a scientific or healthcare discipline preferred and at least 3 - 5 years of monitoring experience. Experience in oncology/onco-hematology global trials preferred Other Qualifications:     Advanced knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and associated regulatory guidelines. At least 3 - 5 years of (CRA)  monitoring experience in the pharmaceutical or CRO industry. An equivalent combination of education, training, and experience may be considered. Experience in oncology/onco-hematology trials preferred Excellent communication and interpersonal skills Ability to establish and maintain effective working relationships with coworkers, managers, and other internal/external stakeholders as applicable Excellent organizational and problem-solving skills and ability to prioritize and multitask Effective time management skills Written and verbal communication skills, including a good command of the English language and German. Computer Skills: Efficient in Microsoft Word, Excel, PowerPoint, Outlook, and use of a laptop computer and iPhone. Travel:   up to 75-80% Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Other Ai Matches

Account Manager – Hematology (Southern New England) Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Director, Biostatistician (Evergreen) Applicants are expected to have a solid experience in handling Biostatistician (Evergreen) related tasks
remote-jobserver Remote
Director, Safety Scientist Applicants are expected to have a solid experience in handling Safety Scientist related tasks
remote-jobserver Remote
Director, Pipeline & Business Development Valuation Applicants are expected to have a solid experience in handling Pipeline & Business Development Valuation related tasks
remote-jobserver Remote
Manager, Commercial Artwork Development Applicants are expected to have a solid experience in handling Commercial Artwork Development related tasks
Clinical Research Associate (All level) Applicants are expected to have a solid experience in handling Job related tasks
Account Manager - Hematology (Houston North) Applicants are expected to have a solid experience in handling Job related tasks
Associate Director/Senior Manager, Business & Strategic Planning & Operations (JAPAC) Applicants are expected to have a solid experience in handling Business & Strategic Planning & Operations (JAPAC) related tasks
Account Manager – Hematology (Southern New England) Applicants are expected to have a solid experience in handling Job related tasks
Estagiário, Acesso ao Mercado e Oncologia (Sao Paulo, Brazil) Applicants are expected to have a solid experience in handling Acesso ao Mercado e Oncologia (Sao Paulo, Brazil) related tasks
remote-jobserver Remote
Executive Director, Operational Strategy & Enablement Applicants are expected to have a solid experience in handling Operational Strategy & Enablement related tasks
remote-jobserver Remote
Senior Director, Global Clinical Operations, Study Start-Up, Americas Applicants are expected to have a solid experience in handling Global Clinical Operations, Study Start-Up, Americas related tasks
Senior Field Medical Director (Senior MSL), Hematology - Carolinas and Virginia Applicants are expected to have a solid experience in handling Hematology - Carolinas and Virginia related tasks
remote-jobserver Remote
Director, Global Commercial Marketing, BTK CDAC Applicants are expected to have a solid experience in handling Global Commercial Marketing, BTK CDAC related tasks
Senior Analyst, QC Chemistry, US Site (Hopewell, NJ) Applicants are expected to have a solid experience in handling QC Chemistry, US Site (Hopewell, NJ) related tasks
remote-jobserver Remote
Associate Director, Oncology Program Management Applicants are expected to have a solid experience in handling Oncology Program Management related tasks
remote-jobserver Remote
Senior Manager, Pipeline and Business Development Valuation Applicants are expected to have a solid experience in handling Pipeline and Business Development Valuation related tasks
remote-jobserver Remote
Senior Director / Executive Director, Hematology Marketing Brand Lead Applicants are expected to have a solid experience in handling Hematology Marketing Brand Lead related tasks
Healthcare Solution Partner (Job Level: Associate Manager(Preferred)/Manager) - Seoul/Gyeongsang Region Applicants are expected to have a solid experience in handling Job related tasks
Sales Innovator 【MR】 (Job Level: Specialist ~ Associate Manager) Applicants are expected to have a solid experience in handling Job related tasks
Senior Analyst, QC Chemistry, US Site (Hopewell, NJ) Applicants are expected to have a solid experience in handling QC Chemistry, US Site (Hopewell, NJ) related tasks
remote-jobserver Remote
Director, US Market Access Strategic Evidence Applicants are expected to have a solid experience in handling US Market Access Strategic Evidence related tasks
Assistant Entity Controller - Swiss Entities Applicants are expected to have a solid experience in handling Job related tasks