Clinical Trial Management Associate Manager

PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATIONLanguage Requirement: Fluent English and Portuguese. Spanish is a plus.Preferred Experience: Pharmaceutical/Biotech Industry, Hematology, OncologyCompany 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 patientsGeneral 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 SOPsEssential 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