Elina Lemesh
Lead Clinical Data Manager at ERT- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
-
English Verhandlungssicher
-
German Muttersprache oder zweisprachig
-
Russian Muttersprache oder zweisprachig
Topline Score
Bio
Sandra Staack „Elina is an excellent Lead Data Manager. In her lead position, she encourages her employees and motivates them to go beyond their own limits. She has a very friendly nature, is open minded but still able to maintain her goals and has immense knowledge in the areas of respiratory, cardiac safety and eCOA data management. I am happy to work with her as my Lead Data Manager.
Sandra Staack „Elina is an excellent Lead Data Manager. In her lead position, she encourages her employees and motivates them to go beyond their own limits. She has a very friendly nature, is open minded but still able to maintain her goals and has immense knowledge in the areas of respiratory, cardiac safety and eCOA data management. I am happy to work with her as my Lead Data Manager.
Sandra Staack „Elina is an excellent Lead Data Manager. In her lead position, she encourages her employees and motivates them to go beyond their own limits. She has a very friendly nature, is open minded but still able to maintain her goals and has immense knowledge in the areas of respiratory, cardiac safety and eCOA data management. I am happy to work with her as my Lead Data Manager.
Sandra Staack „Elina is an excellent Lead Data Manager. In her lead position, she encourages her employees and motivates them to go beyond their own limits. She has a very friendly nature, is open minded but still able to maintain her goals and has immense knowledge in the areas of respiratory, cardiac safety and eCOA data management. I am happy to work with her as my Lead Data Manager.
Credentials
-
Building Self-Confidence
LinkedIn
Experience
-
ERT
-
United States
-
Pharmaceutical Manufacturing
-
700 & Above Employee
-
Lead Clinical Data Manager
-
Nov. 2017 - –Heute
1. Leading and coaching of the assigned team:• Direct the hiring, orientation, and training for the Clinical Data Management team members. Perform routine employee evaluations.• Mentor and develop employees to prepare them for future growth opportunities within the company.• Provide mentoring and training on new equipment, processes, or systems, including new hire orientation and introduction.• Ensure that assigned team members’ data management files are current and complete.• Support routine status meetings with Sponsor/CRO and internal teams for assigned team members.2. Monitor the productivity and quality of the Clinical Data Management team.• Develop the methods to track and report key quality indicators, productivity, successful data delivery, and query metrics.• Conduct routine reviews with Managers, Supervisors, and staff on production and key quality indicators.• Control the quality and properly auctioning edit check output as well as applying the correct edit checks for the trials assigned to the team members.3. All task and responsibilities as a Senior Clinical Data Manager. Please refer to my previous job position.
-
-
Senior Clinical Data Manager
-
Mai 2016 - Nov. 2017
• Client consulting in regard to the data management processes for various service lines.• Improvement and/or development of data management processes in accordance with customer specific requirements.• Evaluation and standardization of data management processes for various types of service lines considering the customer specific requirements.• Support the integration between different technical systems and standardization of processes within various service lines.• Support internal responsible personnel groups by the integration and implementation of new processes within different service lines.• Create and maintain and/or contribute to set up of customer specific metrics and documentation.• Maintain the data in clinical trials’ related databases according to GCP guidelines.• Define/create/maintain the data transfer specification in accordance with customer demanded standards and in cooperation with the customer.• Define/create / maintain the data related documentation e.g. data management plan, data export design specification.• Verify the functionality of the data management tools and contribute to development of tools.• Consulting of customer with the reference to data structure.• Support and consulting the developer groups in regard to the programming of data transfer files.• Validate the data transfer files incl. creation and maintenance of validation documentation.• Create and maintain the data transfer files and verify the data for quality and integrity.• Performing of data corrections and data reconciliation.• Contribute to definition and set up of processes including study specific and system specific training's.• Create and maintain other specific documentation as e.g. working instructions, training's documentation etc.
-
-
Clinical Data Manager
-
März 2011 - Mai 2016
• Maintain the data in clinical trials’ related databases according to GCP guidelines.• Define/create the data export specification in accordance with customer demanded standards and in cooperation with the customer.• Define/create other trials’ and data related documentation e.g. data management plan, data export design specification.• Verify the functionality of the data management tools and contribute to definition of tools.• Consulting of customer with the reference to data structure.• Validate the data export files incl. creation and maintenance of validation documentation.• Create and maintain the export files and verify the data for quality and integrity.• Performing of data corrections and data reconciliation.• Contribute to definition of processes including study specific and system specific trainings.• Create and maintain other specific documentation as e.g. working instructions, trainings’ documentation etc.
-
-
Clinical Data Manager (dormant employment)
-
Mai 2014 - Juli 2015
on maternity leave from May 2014 until July 2015
-
-
Data Manager Assistant
-
Juni 2010 - Feb. 2011
• Manage data correction files.• Performing of data corrections.• Maintain follow up and query processes incl. supporting of customers' sites' Monitors.• Report about the status of a project regarding data corrections level and support Data Manager by creating of statistical study related reports and reconciliation process.
-
-
-
-
Data Manager Assistant
-
Aug. 2009 - Mai 2010
• Manage data correction files.• Performing of data corrections.• Maintain follow up and query processes incl. supporting of customers' sites' Monitors.• Report about the status of a project regarding data corrections level and support Data Manager by creating of statistical study related reports and reconciliation process. • Manage data correction files.• Performing of data corrections.• Maintain follow up and query processes incl. supporting of customers' sites' Monitors.• Report about the status of a project regarding data corrections level and support Data Manager by creating of statistical study related reports and reconciliation process.
-
-
Education
-
1996 - 1998
Kyrgyz Academy of Tourism (Bishkek University)
Associate's degree, Verwaltung/Management, Hotel-/Motel
Community
