CTMA Manager

About the role

The role may be a combination, in variable proportions, of line management and operational responsibilities (CTMA type tasks). This position involves managing a team of Clinical Trial Management Associates (CTMAs) and supporting cross-functional clinical study teams.

Responsibilities

• Plan, assign, and direct work for the CTMA team members.
• Affirmatively contribute to process improvements, best practices, and lessons learned with the team and other colleagues.
• Support study teams with Clinical Operations tasks, including compiling and ensuring the quality of the trial master file (eTMF).
• Adhere to ICH/GCP, local regulations, SOPs, and contribute to the development and/or review of Clinical Operations Work Instructions and SOPs.

Line Management Essential Functions of the Job

• Conduct regular 1:1s with direct reports to assess workload, provide feedback, track goals, and develop them (for BeOne internal CTMAs) or collaborate with FSP CRO LMs (for FSP CTMAs).
• Interview and onboard new hires; ensure ongoing team members' training and adherence 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, addressing both study and individual development needs.
• Coordinate and balance team members' workload, regularly review their quality metrics, and report findings as outlined by clinical operations management.
• Understand the importance of activities and how they fit within the 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.
• 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 developing clinical trial documents, manuals, trackers (may support informed consent development and version tracking).
• Prepare and document internal and external meetings by preparing agendas and minutes.
• Maintain 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.

Supervisory Responsibilities

• Line manage, coach, and mentor Clinical Trial Management Associate (CTMA) team members.

Computer Skills

• MS Office
• Project Planning Applications

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 judgment 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.

Education

• 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.
• 2+ years of previous direct line management experience.
• Oncology experience highly recommended.

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range

$118,600.00 - $158,600.00 annually

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

Equal Opportunity Employer

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.