BeiGene
CTMA Manager, Regional Clinical Study Management
BeiGene, San Mateo, California, United States, 94409
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.
Participate in selection, hiring, and allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and training.
Make direct contributions to process improvements, best practices and lessons learned with team and other colleagues.
Demonstrates very good clinical operations knowledge and strong organizational skills.
Supports 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.
Demonstrate very good command of skills required to support clinical trials.
Contribute to Clinical Operations strategy and performance against key metrics.
Actively participate in 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.
Competencies:
Embraces Change
Communicates Effectively
Drives Excellence
Provides Leadership
Team Player
Mentors
Manages Stakeholders
Computer Skills:
MS Office, Project Planning Applications
Education & Experience Required:
Bachelor’s degree (or equivalent) or higher, preferrably in a scientific, medical, or healthcare discipline.
6+ years of prior clinical trial experience including experience in a management/leadership capacity or demonstrating prior ownership of management/leadership type tasks.
2+ years of previous direct line management experience.
Oncology experience highly recommended.
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.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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.
Participate in selection, hiring, and allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and training.
Make direct contributions to process improvements, best practices and lessons learned with team and other colleagues.
Demonstrates very good clinical operations knowledge and strong organizational skills.
Supports 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.
Demonstrate very good command of skills required to support clinical trials.
Contribute to Clinical Operations strategy and performance against key metrics.
Actively participate in 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.
Competencies:
Embraces Change
Communicates Effectively
Drives Excellence
Provides Leadership
Team Player
Mentors
Manages Stakeholders
Computer Skills:
MS Office, Project Planning Applications
Education & Experience Required:
Bachelor’s degree (or equivalent) or higher, preferrably in a scientific, medical, or healthcare discipline.
6+ years of prior clinical trial experience including experience in a management/leadership capacity or demonstrating prior ownership of management/leadership type tasks.
2+ years of previous direct line management experience.
Oncology experience highly recommended.
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.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.