Ctma Line Manager

vor 2 Wochen

Basel, Schweiz BeiGene Vollzeit

General Description:

- Line manage Trial Support staff. Responsibilities include planning, assigning, and directing work, assessing performance, and guiding 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 support 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

This job description provides the broadest description of potential assigned activities. There will be specific roles and responsibilities assigned from this Job Description, according to project assignment(s). As such, responsibilities will include some of the following activities, but may not be limited to:
Line Management
- Conduct regular 1:1s with up to 10 direct reports (may be a group of BeiGene internal CTMAs and FSP CTMAs) to assess workload, provide feedback, track goals, 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 importance of delegated activities and how they fit within drug development process
- Manage and maintain CTMA resourcing tools
- Constantly strive for operating excellence, question status-quo and promote innovation.
- Contributes to Clinical Operations strategy and performance against key metrics, identifying areas of improvements and propose 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, 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 setup, maintenance and close out of TMF
- Administrative: business and department office administration support if required

Education Required:

- Bachelor’s degree (or equivalent) or higher in a scientific, medical, or healthcare discipline
- Experience in oncology is highly recommended
- Prior clinical trial experience including experience in a management/leadership capacity or demonstrating prior ownership of management/leadership type tasks
- At least 3 years for associate manager
- At least 5 years for manager
- At least 7 years for senior manager
- Previous direct line management experience
- Preferred for associate manager
- At least 1 year for manager

At least 3 years for senior manager

Hiring Levels: Associate Manager, Clinical Operations / Manager, Clinical Operations / Senior Manager, Clinical Operations

Reports To: Senior Manager, Associate Director, or Director, Clinical Operations (or designee)

Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook

Other Qualifications:

- 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%

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- 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

We are proud to be an equal oppo

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