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Senior Clinical Study Manager Line Manager

BeiGene -
Home Office

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Details zur Stelle

Vollzeit
96.000 € – 120.000 € pro Jahr

Qualifikationen

Microsoft Powerpoint
Microsoft Word
Microsoft Excel
Microsoft Outlook
Management-Erfahrung
Textverarbeitung
Forschungserfahrung
Microsoft Office
Projektmanagement
Bachelor
Organisationstalent
Klinische Studien
Certified Scrum Master
PC-Kenntnisse
Führungserfahrung

Vollständige Stellenbeschreibung

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:

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

Salary Range Germany: 96,000.00 EUR - 120,000.00 EUR

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.

Jetzt bewerben

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