北京招聘

Responsibility:

• Quality Checks and oversight
• Quality check and import of all essential documents into the EDMS in a timely manner according to SOP/ICH-GCP/WIs/Local requirements
• Visual quality checks to ensure the legibility ,correct content and proper quality of essential documents in TMF
• Feedback provided to TCM and CML on the health of the TMF including quality and completeness;
• Support trial teams in audits and inspections
• Support trial team in completeness check
• To assist the medical department as BIRDS Key user when needed
• Process and Procedures
• Develop and optimize the eTMF working process
• Implement the tools on TMF management to local OPUs
• To collaborate in the preparation of local procedures and creation of tools if it is required.
• To detect necessity for change of processes and proposes solution
• Training arrangement
• Provide the training on TMF to local team
• Attend the Global/Regional training program
• Communication and Interaction
• Close working with TCM/CMLs/CRAs/CTAs
• Timely communication with global team for issue resolving
• Regular meeting to report the status of TMF Quality and share the working experience with each other
• Work as Site Document Coordinator
• Initiating document workflows with sites
• Review feedback/documents from sites
• Track and follow-up workflow completion
• Quality Checks as outlined in the TMF SOP and attribute assignment
• Completion of safety reporting acknowledgements

Required Education

- Bachelor degree in health sciences or above

Required Capabilities (Skills, Experience, Competencies)

？ Minimum 3 year working experience in pharm industry or other related industry experience on TMF is preferred

？ Team work;

？ Good communication skill and negotiation;

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.