- 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
- 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.
- 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.
- 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.
- 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.
- 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
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Clinical Trial Management Associate Manager - São Paulo, Brasil - BeiGene
Descrição
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION
Language Requirement : Fluent English and Portuguese. Spanish is a plus.
Preferred Experience : Pharmaceutical/Biotech Industry, Hematology, Oncology
Company Overview:
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 10,000 employees across China, the United States (Cambridge, MA; Ridgefield Park, NJ; Emeryville, CA & San Mateo, CA), Switzerland, Australia and Brazil, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients
General Description:
The role may be a combination, in variable proportions, of line management and operational responsibilities (CTMA type tasks).
Essential Functions:
Line Management:
Clinical Operations support to study teams:
Minimum Requirements – Education and Experience:
Other Qualifications:
Supervisory Responsibilities: See Above
Travel: Travel might be required as per business need.
Computer Skills:MS Office, Project Planning Applications
#LI-Remote
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.
