崗位職責(zé):
Able to conduct data management daily works independently, including DM documents preparation, coding, query management, maunal review and other DM related activies.
? Responsible for ensuring the completeness, quality and integrity of the subject data in the clinical trial database.
? Ensure the consistent use and application of applicable data standards. The ultimate objective is to ensure data quality and consistency across programs and repositories.
? Responsible for data management activities within a clinical trial, according to regulations, applicable Standard Operating Procedures (SOPs) and Processes.
? Works with the global study team to meet the study objectives.
JD: For Hands-on data management (Data Manager)
? Create and implement the Data Management Plans (DMP) to ensure data completeness and accuracy.
? Set-up and test data review listings to verify the quality and completeness of data as specified in DMP.
? Ensure timely set-up of clinical data acquisition and management tools and data validation.
? Maintain study tracking to ensure timely CRF retrieval, data entry and data cleaning activities.
? Perform data cleaning activities including discrepancy management (review of errors from electronic checks) and review of data listings to verify quality and completeness of data.
? Ensure integrity of clinical data and update database by issuing and resolving DCFs as necessary.
? Reconcile the patient database with the Serious Adverse Event database.
? Document all efforts of data management and file all responsible documents.
任職要求:
At least 1 to 2 years full time work experience as DM focus on drug trial.
? Bachelor degree or above
? Have basic sense of ICH-GCP.
? Smart and quick to catch up. Have good capability in self-learning, communication and planning.
? Better to have experience in global pharmaceutical company studies
? Better to have strategic thinking and risk management sense.
Be capable of working under high pressure
Requirement on EN
? Listening-able to take EN training and meetings
? Speaking-able to communicate with EN speaking people clearly
? Reading-able to read EN protocol and academic materials
? Writing-able to write EN e-mails and reports
職位福利:五險一金、交通補(bǔ)助、餐補(bǔ)、帶薪年假、補(bǔ)充醫(yī)療保險、定期體檢、高溫補(bǔ)貼、節(jié)日福利