Yi-Ning(Elina) Deng

Experience

• 

  Clinical Service Center

  Nov 2020 - Jun 2024

  - Take responsibility for specific tasks on projects, or acts as the main CDM contact on individual projects.- Train team members on selected tasks- Prepare Data Management Plan- Prepare the Data Validation Plan- Develop or provide input to project specific guidelines, e.g. SAE handling.- Initiate the running of study specific programs- Utilize current study documentation including protocol, Case Report Forms (CRFs), Cleaning guidelines etc.- Conduct in-house data review,- Generate and close queries or apply self evidence corrections to the data according to the relevant guidelines- Identify and report protocol violations- Manual and Patient Profile review, issue queries- Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action- Track and integrate queries- If required liaise with 3rd party vendors to clean electronic data- Ensure all documents coded for submission to central files- Lock site(s) within EDC system - remove user's data modification privileges- Interact with site (via mail) as required- Perform early and final database QC activities- Update all relevant tracking system on an ongoing basis- Inform responsible CDM Coordinator of work status regularly- Keep Manager informed about work progress and any issues to avoid surprises. Requires some interaction / supervision by Manager or assigned mentor Show less - Utilize current study documentation including protocol, Case Report Forms (CRFs), Cleaning guidelines etc. - Conduct in-house data review - Generate and close queries or apply self evident corrections to the data according to the relevant guidelines - Identify and report protocol violations - Manual and Patient Profile review, issue queries - Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action - Track and integrate queries - Perform clinical coding if appropriate to role within the project team - Ensure all documents coded for submission to central files - Lock site(s) within EDC system - remove user's data modification privileges - Interact with site (via mail) as required - Perform early and final database QC activities - Update all relevant tracking system on an ongoing basis - Keep manager informed about work progress and any issues to avoid surprises. Requires regular interaction / supervision by Manager or assigned mentor - Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and Meta-Clinical WSOP and stud specific procedure - Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims - Inform responsible CDM coordinator of work status regularly Show less

  • Clinical Data Manager II

    Jan 2022 - Jun 2024

  • Clinical Data Manager I

    Nov 2020 - Jan 2022
• 

  Everest Clinical Research

  Jun 2024 - now

  Clinical Data Manager II