"PURPOSE
A fresher level resource that provides clinical lab data expertise as part of a team to follow Laboratory Data Management (LDM) tasks for the studies awarded to Q squared solutions and meets the external client data reporting needs.
RESPONSIBILITIES
Should have knowledge of lab test parameters, its purpose, clinical & scientific significance of those tests.
Should be able to understand and follow trial specific data handling guidelines.
Should be able to read and understand laboratory reports and transcribe the information into LIMS system with quality.
Should be able to perform second review/QC of transcribed result.
Should be able to identify any issues or errors on lab report and accordingly raise queries to lab for clarification.
Should be able to work and address data reconciliation issues with EDC database.
Document completion status in work management tool.
Should learn to execute pre-existing SAS programs that are required to perform the job.
Should be able to understand if there are any errors generated while executing programs or use of tools.
Interact within team to bring errors, concerns and discuss the resolution.
Co-ordinate with other departments to get closure on pending data.
email communication with client.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Strong customer-focus perspective with skill to guide customer communications and customer management.
• Self-driven; keen attention to detail to anticipate, address and/or escalate issues, with aptitude to embrace and be conduit for change.
• Project and task management capabilities to meet/exceed deliverables.
• Effective problem solving skills as well as ability to proactively identifying process improvements which reduce operational costs and maintain quality.
• Quality conscious with high degree of ethics and integrity carrying out duties in accordance to laws, regulatory standards, and with company policies and procedures.
• Computer proficiency including word processing, spreadsheet and Power Point applications hands on experience.
• Good understanding of medical, clinical research, and Lab Data Management process and terminology.
• Knowledge on elicitation of the data requirements and authoring specifications.
• Knowledge on various regulatory requirements such as FDA, ICH, ISO HL7, and GLP (Good Laboratory Practices) will be an added advantage.
• Knowledge on Microsoft Excel, Advanced Excel, Vlookups and Pivot Table.
Qualification:
• Bachelor’s degree or educational equivalence in computer/life science or Medical Technologist or Clinical Laboratory Scientist degree with clinical laboratory experience or related field with 0-1 years of relevant work experience ; or equivalent combination of education, training and experience."
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.