Clinical Data Associate

Job Description

Title: Clinical Data Associate

Company Name: Toxicology Society of Bangladesh (TSB)

Vacancy: Not specific

Job Location: Chattogram

Employment Status: Full-time

Educational Requirements:
∎ University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree

Experience Requirements:
∎ At least 2 year(s)

Job Responsibilities:
∎ To provide excellent data management for CCBOC & other research studies as applicable. This role will include electronic CRF management and design, developing and managing data management plans. This person will coordinate with the sites for query resolutions as per the study requirement.

∎ Position Summary
∎ Define, develop and manage the data management plan, quality control for data management (including the definition of automated data queries, development of visit- by-visit guides and source data verification strategy and implementation plan).
∎ Support the design of CRFs, explaining the level of data definition required and work with researchers to advise on best practice for CRFs.
∎ To undertake QA checks and validation of databases, and performing checks on database documentation, before the release of the database to the users
∎ Liaise with data collection sites, providing training and updates to site researchers on data collection, compliance and CRF amendments
∎ Manage data query resolution, producing reports and working with sites to support the resolution of queries. Follow up incorrect or incomplete data discrepancies with the relevant sites
∎ Accountable for the high quality of data collection in the case report forms, and test results into the relevant trial database. Ensure that all information is constantly updated and available for interrogation by the trial manager, principal investigators, and chief investigators.
∎ Perform quality checks on data entry regularly
∎ Compile data management documentation as required, and monitor QA compliance of the data management processes.
∎ Create reports and submit it to the trial statisticians on a regular basis for the data review and analysis
∎ Perform data cleaning and keep it ready for the interim and end analysis for the DMC, TSC meetings
∎ Support data management related activities as when assigned
∎ Co-ordination with the database team, programming team, UoE data manager as when required to ensure smooth data management operation.
∎ Be proactive in monitoring data flow into study databases, identify where there are problems and develop solutions to overcome these.
∎ Liaise with recruitment sites where a problem with data entry has been identified and work with them to find a solution.
∎ Lead the QA function for data management systems and provide suggestions for ongoing quality improvements.

Additional Requirements:
∎ Minimum 2 years or more experience in electronic data capture system (eCRF) like Oracle RDC, Medidata or any other web-based or mobile application-based data collection tool in phase II, phase III clinical trials
∎ Excellent technical and analytical mindset to identify the data discrepancy
∎ Solid knowledge of international data quality standards
∎ Critical thinking and problem-solving skills
∎ Very good working knowledge of Outlook, Word, Excel, PowerPoint and Access, and must have confidence and expertise to work with new database systems.
∎ Experience of clinical trial data entry would be an advantage
∎ Ability to work within strict guidelines and prioritize workloads in short to medium term.
∎ Decision-making, planning and organizing skills
∎ Excellent communication skills in English
∎ High level of work ethics, detail-oriented
∎ Excellent co-ordination and organizational skills
∎ Must have experience in working with confidential data.
∎ Good knowledge of medical terminology would be desirable.
∎ Fluency in both languages English and Bangla is compulsory.
∎ Must be a team player
∎ Knowledge of Good Clinical Practice (GCP).SDTM, CDISC and other data standards as applicable
∎ Preferably candidate from the Banladesh

Application Deadline: 21 Sep 2020

Company Information:
∎ 22 Aug 2020
∎ Toxicology Society of Bangladesh (TSB)
∎ Address : Room no: 415, Academic Zone (3rd floor), Dhaka Medical College Hospital-2, Dhaka.

Category: IT/Telecommunication

Source: bdjobs.com

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