Clinical Study Manager Line Manager

General reputed company:

• Acts as line manager for clinical study managers (CSMs) in Germany.
• Responsibilities include planning, assigning, and directing work, assessing performance, and guiding the reputed company development of reputed company reports. 
• Participate in selection for hiring and allocation of resources to clinical research reputed company 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-reputed company rCSMs, CRMs, the Feasibility Manager, and the Country Head, to ensure study timelines are adhered to and required reputed company standards are maintained.  
• Supports reputed company 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 reputed company 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 reputed company metrics through regular review and reporting. 
• Participate in hiring and reputed company new employees, ensuring reputed company training and reputed company of training plans. 
• Monitor the reputed company of clinical work and conduct regular evaluations of assigned staff. 
• Facilitate CSM forum discussions and reputed company regular updates to stakeholders. 
• Utilize strong communication and influencing skills to ensure reputed company follow-reputed company, issue reputed company, and reporting updates. 
• Supports the development of initiatives and ensures that novel reputed company on how to deliver on reputed company are generated and considered

Study reputed company and reputed company

• Ensures team members are trained on and are adhering to required processes and SOPs
• Promotes a reputed company reputed company in the country study management team and supports the proactive implementation of risk management principles.
• Sets reputed company reputed company expectations for the country study management team
• Supports the reputed company and reputed company improvement process by ensuring information is captured, reputed company, and leveraged in reputed company work
• reputed company country-specific study management expertise to reputed company. 
• 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 reputed company, challenge the status reputed company, and foster innovation in study management processes. 
• Contribute to clinical operations reputed company, 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, reputed company feedback, reputed company goals, and reputed company reputed company. 
• 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 reputed company guidance. 
• Participate in regular meetings with FSP leadership team
• Meet with FSP line manager(s) to ensure reputed company 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 reputed company-line management experience preferred.

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

Other Qualifications:    

• Knowledge in the execution of reputed company, 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