北京招聘

Reporting Relationships

The Clinical Data Manager (CDM) II is based in the Data Management & Project Systems function.

Key accountabilities

Clinical Data Manager II will additionally be accountable for the following activities (as well as those above):

? Contribute to the set-up of clinical trial databases in set-up phase

? Contribute to study documentation during the set-up phase

? Coding of medications and medical events

? Data reconciliation activities

? Effective communications with cross-functional project teams

? Contribute to the delivery of a clean clinical database

Key accountabilities as a Team Member:

? Participate in team meetings and activities

? Participate in objective setting, performance management

? Participate in special projects to improve processes, tools, systems and organisation

? Comply with OH&S legislation and operate in accordance with established OH&S

practice and procedures at the organisation.

? Promote and contribute to a safe, secure environment for staff and visitors

Compliance and Training

• Complete and document mandatory training for this role within specified timelines
• Attend and document mandatory training workshops required for this role
• Comply with all applicable regulations, guidelines, SOPs and project-specific requirements
• Comply with all designated systems relevant to this role
• Ensure own quality control of all relevant processes and activities performed

· Report and escalate identified issues in areas of responsibility according to George Clinical and/or project requirements

Customer Focus and Teamwork

• Attend and actively participate in George Clinical meetings and other internal meetings as required
• Provide input to systems, tools and process improvements

Occupational Health and Safety

• Comply with OH&S legislation and operate in accordance with established organisational OH&S practice and procedures
• Promote and contribute to a safe, secure environment for staff and visitors

Skills, Knowledge and Experience

? Tertiary qualifications in science or related field

? A CDM II demonstrates strong data management skills and thorough knowledge of the data management process

? Experience with use of electronic data capture (EDC) tools, for instance RAVE, InForm or other web-based data capture tools is preferable.

? Knowledge of Good Clinical Practice (GCP) and applicable regulatory guidelines, especially as related to data handling and processing

? Ability to evaluate and recommend changes to existing processes and procedures for greater effectiveness

? Excellent time management and project management skills

? Excellent written and verbal communication skills

? High level problem solving, analytical, and strategic thinking skills

? Excellent interpersonal skills and the ability to work well and flexibly ie. autonomously, in small teams and with a wide range of varying stakeholders, including senior management

? Ability to see the big picture, whilst still maintaining a focus on detail and implementation

? Ability to be flexible and adaptable in the face of changing organisational priorities and ambiguous environments

? Strong focus on quality of work

The George Institute China is a medical research institute, and a wholly-owned foreign enterprise, that was established as an affiliated partner with Peking University Health Science Centre in March 2007, whose registered name is Beijing George Medical Research Co. Ltd. The aim of the Institute is to promote high quality medical research through the conduct of randomised controlled trials and epidemiological studies with various government and non-government partners for the purpose of providing evidence-based approaches to improve the health of Chinese people.
George Clinical is the clinical research delivery arm of the George Institute and manages phase I to phase IV clinical studies for both commercial and medical research organisations. George Clinical is recognized as a leading Clinical Research Organisation (CRO) bringing together medical and scientific expertise in the clinical trials area. George Clinical China is a wholly owned foreign enterprise and trades under the name George (Beijing) Clinical Research Co. Ltd.