南京招聘

职位描述：
RCTM

Key Responsibilities

? Leading the regional matrix team (e.g. CRA, CTA, etc.) to ensure delivery of country and site level study activities in alignment with the global study project plan
? Identifying and resolving issues at a regional level
? Collaborating with Global CTM to ensure country level study delivery is aligned with the global study project plan
? Contributing to study-level risk assessments
? Leading and continually review regional risk mitigation activities to ensure study delivery to plan
? Overseeing regional insourcing/outsourcing partner deliverables to the required standards Partnering with Tech Services, Supplier Governance and Electronic Trial Operations - to ensure regional, country and site vendor set-up, conduct and quality Leading regional documentation and required tool and systems set-up
? Contributing to regional aspects of Drug Supply Plan
? Ensuring implementation of study(ies) in accordance with SOPs and ICH/GCP guidelines

Basic Qualifications

? BA/BS/BSc or RN
? Broad experience working in life sciences or medically related field, including general biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company)

Preferred Qualifications

? BA/BS/BSc in the sciences or RN
? Previous management experience of direct reports
? Experience in oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc.)

Knowledge

? Working knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP), and applicable international regulations and guidelines
? Clinical Development process and procedures
? Project planning experience including oversight of study deliverables, budgets, and timelines
? Ability to use scientific and clinical knowledge to conceptualize study designs
? Experience anticipating and resolving problems
? Experience writing and presenting clearly on scientific and clinical issues
? Experience collaborating and leading cross-functional teams (team/matrix environment)
? Knowledge of project risk management assessment and mitigation approaches

Key Competencies

? Project Management
? Risk assessment
? Critical Thinking and Planning
? Matrix Team organization/leadership
? Metrics analysis
? Written and oral communication
? Delivery focus
? Decision Making
? Problem solving
? Relationship management
? Conflict resolution
? Adaptability and Flexibility
? Working in virtual teams


If you are interested in these roles, pls for free to contact me by : Jenny.Zhang@docsglobal.com 举报 分享

We are a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.