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, Contractual
Educational Requirements:
∎ Masters degree in any discipline
∎ Graduation in Life Science, Computer Science, Pharmacy, Statistics, Mathematics, Software Engineering or equivalent relevant degree
Experience Requirements:
∎ At least 1 year(s)
Job Context:
∎ 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.
∎ Reporting to Senior Trial Manager
∎ Key Stakeholders: Site Trial coordinator, Research Assistants (Co-investigators), Research administrator logistics manager, Trial database developer, Trial programmer, and Statisticians.
Job Responsibilities:
∎ 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.
∎ You will be assigned to multiple studies as per the organization requirement.
∎ Key Performance Indicators: Support execution of CCBOC study according to study protocol/ SOPs/ GCP/regulatory guidelines
∎ Excellent discrepancy management
∎ Data analysis, insights, dashboard and reporting to manager
∎ Meet Database lock timelines
∎ Proactively mitigate data management issues with the research sites
∎ High-quality data collection and ensure a smooth migration and archival of the data as per the requirement of the study.
Additional Requirements:
∎ Age 22 to 40 years
∎ Key Competencies: Minimum 2 years of 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
∎ You need to be competent on certain skills like MS excel advanced, data analysis, power point presentation, and some specific software like R, SPSS or any skill needed to align with your role within this three (3) months. These are must have skill requirement.
∎ 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 advanced, 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 coordination 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
Salary: Negotiable
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 1 Dec 2023
Company Information:
∎ 27 Nov 2023
∎ Toxicology Society of Bangladesh (TSB)
∎ Address : 14/14, Block:A, Road No.:1, Shugandha R/A, Panchlaish-4203
Category: IT/Telecommunication
: Only Shortlisted candidates will be asked for the interview.
Deadline Expired on 1st Dec 2023
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