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Data Management Associate

Covance - Regional, India

3/12/2018 8:02:06 PM
Clinical Operations

Job Overview

The Data Manager is accountable for acting as the primary liaison between Covance Central Laboratory Services and Sponsors, to ensure the successful management of global projects through compliance with the Covance Central Laboratory Services Clinical Data Management strategy, in order to deliver outstanding customer satisfaction.

Essential Job Duties:

1. Supporting data management during start up.

* Create protocol folder(s) for study documentation.
* Add entries into individual protocol spreadsheet departmental metrics tool.
* Review sections in the SOW for the feasibility of data transfer
* Start up File Delivery task - Running Reference Range Report from DT4 and conversion to send to the client
* Implement the recommendations and alternatives accepted to ensure data quality
* Implement the changes from the collaboration(s) for the Data Transfer Specifications( or work to help with the creation of the DTA/PSA prior to the collaboration)
* Creation of a lab file and a container file on specific studies
* Administrative revisions and customizations to Standard Study Set-Up turnaround timeline document (post the test file) and the multiple discussions and action items to finalize the same)

2. Act as a data liaison between Clinical Data Management and all other Covance departments and business units.

* Implement actions from the DM for their study questions
* Issues pertaining to storage location defined in the SMART database
* Follow up with IT for data elements transfer issue from Zavacor to CT Database
* Follow up with internal study team for pending data during Study Interim, Final Lock
* Work with RLI , Lab Corp for pending data resolution.
* Partner with other Covance departments and business units, and provide integrated support and process improvements as needed.

3. Queries
* Manage client queries , submit to Data analyst in DRC for review and research
* Review and research questions from client if data analyst is not able to resolve or identify issues
* Research Zavacor database for study set up to review Calculation criteria , Toxicity grade crietria, Alert Flag set up are as per clients standards.
* Manage client request for patients demographic changes and other request to update the database. Manual revision or MDR (Mass data revision)
* Submitting requests for data changes to the DRC and assisting the DM to make other data changes for ensuring compliance on the study

4. General support
* CDISC or any other internal list related test mapping
* Client specific administrative responsibilities as assigned
* Support Clinical Data Management department and Data Manager administrative responsibilities as assigned.
* Complete Quality Assurance tasks as assigned.
* Record required departmental metrics.
* Proactively check for IVRS issues daily. Set up IVRS automated process for all IVRS studies.
* Generate shipping manifests for daily, weekly, monthly and adhoc requests.
* Generate managements reports for daily, weekly, monthly and adhoc requests.

5. Create standard data transfer format(s) in compliance with client requests while adhering to both internal processes and regulatory standards.

* Build and modify Data Transfer formats as needed.
* Build Templates for CDISC, Standard modules, XML, SAS , XPT based on client needs and requirements.
* Create test data if needed.
* Identify study specifics requirement, build mock patients, test code groups , test codes, results value manually for test transfers.
* Initial and basic QC of the test files and file formats during set-up, modification and closeout.
* Log in test file delivery information to the departmental metrics tool
* Store auditable documentation within appropriate folder structure

6. Provide ongoing data management support during study maintenance.

* Create global transmission instructions.
* Schedule appropriate frequency of data transfers.
* Address errors and client issues including queries.
* Participate in internal study-related meetings
* Implement the changes from the study modification discussions
* Confirm changes and send files as needed.
* Maintain auditable documents.
* Facilitate Data Management functions of end-to-end data lock processes.
* Implement the requirements from the new service requests
* Reviewing Error Report and updating UDAs
* Review the properties of data files and error reports. Inform DM I of any findings and follow-up as needed.
* Loading data for Phase I studies and ensure all data is loaded correctly

7. Ensure uninterrupted client service.

* Support peers by sharing technical knowledge and customer service skills.
* Back up peers as needed.

8. Record data transfer activities and maintain protocol portfolios as required to track workload and productivity.

9. Work in collaboration with Clinical Data Manager personnel to assist in day to day activities as assigned.

10. Other duties as assigned.


Data Manager1 are most successful at Covance with:

* A graduate in any stream
* Good communication skills
* High degree of attention to detail
* Demonstrated customer service skills


* 1-2 years of related Experience

Position Type: Full-Time

Location: Regional, IND - India

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