CTMA Associate Line Manager

 General Description: 

The role is a combination of line management and operational responsibilities, in different proportions. In general, the balance is 50/50, but variations may apply and are to be expected.   

• Line manage Trial Support staff. 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.  

• Proactively seeks opportunities to support, contribute or lead improvements, implements best practices and shares lessons learned with team and other colleagues – various levels of involvement possible, depending on seniority in the role  

• Supports study teams with Clinical Operations tasks, and/or supports compilation and quality of the trial master file (TMF)   

• Demonstrates basic clinical operations knowledge and strong organizational skills  

• Adheres to ICH/GCP, local regulations, SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs  

Essential Functions of the Job:  

Line Management: 

• Conduct regular 1:1s with up to 10 direct reports (may be a group of BeOne internal CTMAs and FSP CTMAs) to assess workload, provide feedback, track goals, and development. For the FSP CTMAs, meet regularly with FSP line manager(s) to ensure timely feedback.  

• Conduct quarterly, mid-year, and year-end performance reviews  

• Interview and onboard new hires; ensure ongoing training compliance.  

• Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.  

• Demonstrates mastery of skills required to support clinical trials. 

• Understands the importance of delegated activities and how they fit within drug development process  

• Manage and maintain CTMA resourcing tools  

• Constantly strive for operating excellence, question the status quo, and promote innovation.  

• Contributes to Clinical Operations strategy and performance against key metrics, identifying areas of improvement and proposing solutions - various levels of involvement possible, depending on seniority in the role  

• Support, contribute or lead the development of local/global workstreams - various levels of involvement possible, depending on seniority in the role.  

• Participate in and help facilitate CTMA Forum discussions  

Clinical Operations support to study teams:  

• Provides support to cross-functional clinical study teams from start-up through close-out:  

• Assists in development of clinical trial documents, manuals, and trackers (may support informed consent development and version tracking)  

• Preparation and documentation of internal and external meetings by preparing agendas and minutes  

• Maintaining clinical operations tracking tools (e.g. CTMS, EDC, IRT) as instructed by the study lead  

• Contributes to the setup, maintenance and close out of TMF  

• Administrative: business and department office administration support if required  

Education Required:    

• Bachelor’s degree or higher in a scientific or healthcare discipline, and advanced degrees preferred.  

• Experience in Oncology is highly recommended.  

Computer Skills:    

• Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook. 

Other Qualifications: 

• Minimum 3 years of industry experience in the pharmaceutical, CRO, or relevant field  

• Thorough understanding of the drug development process, including expert knowledge of international standards (ICH-GCP) and health authority requirements  

• Prior clinical trial experience, including experience in a management/leadership capacity or demonstrating prior ownership of management/leadership-type tasks   

• Ability to work independently and effectively handle multiple priorities in a fast-paced environment  

• Excellent interpersonal skills, strong organizational skills and effective written and verbal communication skills across all levels within an organization  

Travel:  up to15%