Senior CTMA Manager, Regional Clinical Study Management

General Description: 

The role may be a combination, in variable proportions, of line management and operational responsibilities (CTMA type tasks).  

• Line manage Clinical Trial Management Associate (CTMA) team members. Responsibilities include planning, assigning, and directing work, assessing performance, and guiding professional development of direct reports. 

• Lead the selection, 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 participate and lead process improvements, best practices and to share lessons learned with team and other colleagues. 

• Demonstrates advanced clinical operations knowledge and has strong organizational skills. 

• Leads study teams with Clinical Operations tasks, and/or support compilation and quality of the trial master file (eTMF).  

• 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 direct reports (may be a group of BeiGene internal CTMAs and FSP CTMAs) to assess workload, provide feedback, track goals, development (direct development discussions in case of BeiGene internal CTMAs, development discussions & collaboration with FSP CRO LMs in case of FSP CTMAs). For the FSP CTMAs, meet regularly with FSP CRO LM(s) to ensure timely feedback. 

• Conduct regular performance reviews with direct reports (e.g., mid-year, end-year). 

• Interview and onboard new hires; ensure ongoing team members training, and adhesion to internal processes and SOPs. 

• Promote a quality mindset in the organization and support the implementation of risk management principles. 

• Contribute to the resource allocation process by assigning the right person to the right study at the right point in time, while addressing both study and individual development needs 

• Coordinate and balance team members’ workload, regular review of their quality metrics, and reporting of findings as outlined by clinical operations management. 

• Understand importance of activities and how they fit within drug development process; oversee appropriate and effective delegation of tasks inside the team. 

• Manage and maintain CTMA resourcing tools. 

• Ensure operational excellence; question status-quo and translate it into actionable plans; promote innovation and translate it into implementable initiatives. 

• Demonstrate master of skills required to support clinical trials. 

• Contribute to (or leads part of) Clinical Operations strategy and performance against key metrics.  

• Contribute to (or leads) the development of local/global process improvement activities. 

• Participate in and help facilitate CTMA formal group discussions. 

• Other duties as assigned. 

Clinical Operations support to study teams: 

Provide support to cross-functional clinical study teams from start-up through close-out. 

• Assist in development of clinical trial documents, manuals, 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 tools (e.g., CTMS, EDC, IRT) as instructed by the study lead. 

• Contribute to setup, maintenance and close out of eTMF. 

• Other duties as assigned. 

Computer Skills:     

MS Office, Project Planning Applications 

Other Qualifications:   

• Solid leadership and management experience either as direct line manager or as cross functional team lead. 

• Strong written and verbal communication skills. 

• Exercises sound judgement and discretion in matters of significance. 

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

• Excellent interpersonal skills, strong organizational skills and ability to influence and lead.  

Travel:    

Travel might be required as per business need.