Senior Clinical Research Associate

BeiGene, Ltd.; Deutschland; On-site; EUR 66,000 - 83,000; Full time

Job summary

BeOne seeks an experienced Clinical Research Associate to perform site monitoring for oncology trials, ensuring compliance with ICH-GCP and regulatory standards. You will collaborate with country and regional teams to maintain study timelines and data quality.

Responsibilities include site management, training at sites, and maintaining essential documentation in the TMF/ISF, with up to 80% travel across regions. English and German language skills are essential.

Qualifications

• 5+ years of (CRA) monitoring experience in pharma or CRO.
• Experience in oncology trials preferred.
• Advanced knowledge of GCP/ICH regulatory requirements.
• English and German language skills are required.

Responsibilities

• Perform site monitoring visits per monitoring plan and SOPs.
• Create and maintain study documentation in the TMF and ISF.
• Coordinate with Country/Regional teams to ensure timelines and data quality.
• Escalate risks and collaborate with site staff to implement CAPA.

Skills

Communication skills

Interpersonal skills

Organization

Time management

Bilingual English/German

Education

BS in science

Tools

MS Word

MS Excel

PowerPoint

Outlook

Job description

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.

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) compliance, 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.
• 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 80%

Salary Range

EU: 66,200.00 EUR - 82,800.00 EUR

Global Competencies

• 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

Equal Opportunity Employer

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.

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents.

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.

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China Mainland Job Posting At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things.

Values

• Patients First
• Driving Excellence
• Bold Ingenuity
• Collaborative Spirit