Senior Clinical Study Manager Line Manager

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 achieve corporate goals effectively. 
• Proactively seeks opportunities to lead and drive improvements to optimize efficiencies within 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 Oversight 

• Provides leadership, management, and/or mentorship to Clinical Study Managers (CSMs)
• Manage CSMs in line with BeOne’s policies and regulations. 
• Oversee CSM resources and ensure staff meet defined workload and quality metrics through regular review and reporting. 
• Participate in hiring and onboarding new employees, ensuring proper training and oversight 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-ups, issue resolution, and reporting updates. 
• Supports the development of initiatives and ensures that novel ideas on how to deliver on clinical trials are generated and considered

Study Oversight and Quality

• Ensures team members are trained on and are adhering to required processes and SOPs
• Promotes a quality mindset 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 knowledge management and continuous 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 quo, 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 onboard new hires; ensure ongoing training compliance. 
• Conduct regular 1:1s to assess workload, provide feedback, track goals, and develop the team. 
• Conduct mid-year and year-end performance check-ins and reviews. 

Functional management – FSP 

• Onboard 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 healthcare discipline preferred, with a minimum of 8 years of progressive experience in clinical research and clinical operations, preferably within the biotech, pharmaceutical sector, or CRO environment. At least 7 years for a Senior Manager.
• Previous direct-line management experience preferred.

Computer Skills:   Proficient in Microsoft Office – Outlook, Word, Excel, 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 and German

Travel:  Occasional