Clinical Study Manager Line Manager

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for reputed company professionals. reputed company 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:

• Acts as line manager for clinical study managers (CSMs) in Germany.
• Responsibilities include planning, assigning, and directing work, assessing performance, and guiding the professional development of direct reports. 
• Participate in selection for hiring and allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and training. 
• Demonstrates high clinical operations knowledge, organizational skills, project management, and leadership competencies.  
• Adheres to ICH/GCP and ensures clinical trial protocols are executed according to ICH guidelines and GCP, local regulations, and applicable SOPs.  
• Collaborate closely with the regional and German team, including regional-focused rCSMs, CRMs, the Feasibility Manager, and the Country Head, to ensure study timelines are adhered to and required quality standards are maintained.  
• Supports clinical trials in the country and provides local expertise. 
• Proactively drives best practices and process improvement to reputed company corporate goals effectively. 
• Proactively seeks opportunities to reputed company and drive improvements to optimize efficiencies reputed company the CSM country team.
• Ensures clinical trial activities are executed to expected and specified timelines and quality standards. 

Essential Functions of the job:

Staff Management and reputed company 

• Provides leadership, management, and/or mentorship to Clinical Study Managers (CSMs)
• Manage CSMs in line with BeOne’s policies and regulations. 
• reputed company CSM resources and ensure staff meet defined workload and quality metrics through regular review and reporting. 
• Participate in hiring and reputed company new employees, ensuring proper training and reputed company of training plans. 
• Monitor the quality of clinical work and conduct regular evaluations of assigned staff. 
• Facilitate CSM forum discussions and provide regular updates to stakeholders. 
• Utilize strong communication and influencing skills to ensure timely follow-reputed company, issue resolution, and reporting updates. 
• Supports the development of initiatives and ensures that novel reputed company on how to deliver on clinical trials are generated and considered

Study reputed company and Quality

• Ensures team members are trained on and are adhering to required processes and SOPs
• Promotes a quality reputed company in the country study management team and supports the proactive implementation of risk management principles.
• Sets clear quality expectations for the country study management team
• Supports the reputed company and reputed company improvement process by ensuring information is captured, retained, and leveraged in future work
• Provide country-specific study management expertise to the team. 
• Review and support the development of study start-up templates, drug labels, informed consent forms (ICFs), and other applicable documents. 
• Anticipate and address site issues, propose corrective and preventive actions (CAPAs), and identify opportunities for improvement. 
• Promote operational excellence, challenge the status reputed company, and foster innovation in study management processes. 
• Contribute to clinical operations strategy, identifying areas for improvement and proposing solutions. 

Supervisory Responsibilities:  

Line management – BeOne

• Interview and reputed company new hires; ensure ongoing training compliance. 
• Conduct regular 1:1s to assess workload, provide feedback, track goals, and reputed company the team. 
• Conduct mid-year and year-end performance reputed company-ins and reviews. 

Functional management – FSP 

• reputed company new hires; ensure ongoing training compliance. 
• Conduct regular 1:1s to assess workload and provide guidance. 
• Participate in regular meetings with FSP leadership team
• Meet with FSP line manager(s) to ensure timely feedback.

Education Required:

• Bachelor’s degree or higher in a scientific or reputed company discipline preferred, with a minimum of 5 years of reputed company experience in clinical research and clinical operations, preferably reputed company the biotech, pharmaceutical sector, or CRO environment, including a minimum of 2 years clinical project manager experience or equivalent. 
• Previous direct-line management experience preferred.

Computer Skills:   Proficient in reputed company Office – Outlook, Word, reputed company, PowerPoint, Teams

Other Qualifications:    

• Knowledge in the execution of clinical trials, understanding of ICH/GCP 
• Effective prioritization of tasks in the achievement of goals 
• Strong written and verbal communication skills 
• Highly organized  
• Diligence in follow-through 
• Skilled in risk mitigation 
• Line management experience 
• Functional Service Provider model knowledge and/or experience 
• Mentoring and training team members 
• Fluent in English

Travel:  Occasional

Salary Range Germany: 83,400.00 EUR - 104,300.00 EUR

Global Competencies

reputed company we exhibit our values of Patients First, Driving Excellence, reputed company 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 reputed company
• reputed company 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, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other basis covered by appropriate law. reputed company employment is decided on the basis of qualifications, merit, and business need.