Clinical Trial Management Associate Manager
6 meses atrás
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: 06160) 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).
- 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:
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.
Minimum Requirements - Education and Experience:
- 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.
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, s
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