(Associate) rCTMA Manager (CTA Line Manager), Beijing/Shanghai/Guangzhou

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.
• Support selection, hiring, and allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and training.
• Support process improvements, best practices and lessons learned with team and other colleagues.
• Demonstrate good clinical operations knowledge and strong organizational skills.
• Support 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.
• Support 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.
• Constantly strive for operational excellence, question status-quo and support innovation.
• Demonstrate good command of skills required to support clinical trials.
• Support the Clinical Operations strategy and performance against key metrics.
• Support the development of local/global process improvement initiatives.
• 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.

Education & Experience Required:

• Bachelor’s degree (or equivalent) or higher, preferably in a scientific, medical, or healthcare discipline.

• 5+ years of prior clinical trial experience including experience in a management/leadership capacity or demonstrating prior ownership of management/leadership type tasks.

• Previous direct line management experience

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• Oncology experience highly recommended.