Senior Clinical Study Line Manager

Job Title: Senior Clinical Study Line Manager Job Location: Poland Remote Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: 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 the given country(ies). - 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 country(ies) 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 as well as within the EU and Global region. - 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 regional study management organization and supports the proactive implementation of risk management principles in the regional study management organization - 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.