Clinical Data Validation Engineer Specialist Job at iconplc (Bangalore)

AI Data Specialist

We are seeking an AI Data Specialist with healthcare domain expertise to support...

Location

Canada , Toronto

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

Bachelor's degree in Computer Science/IT/Data Science, Health Informatics, or related field
8+ years of experience working as data specialist
Strong understanding of US healthcare payer data (claims, eligibility, clinical, pharmacy)
Proficiency in Python and SQL and experience with data quality and validation practices
Experience working in cross‑functional teams

Job Responsibility

Acquire, validate, and manage healthcare data from EHR/EMR systems, claims platforms, laboratory systems, medical devices, and third-party vendors
Ensure data completeness, accuracy, consistency, timeliness, and integrity across the healthcare data lifecycle
Perform data profiling, cleansing, normalization, and enrichment activities
Transform raw healthcare data into analytics- and AI-ready datasets
Collaborate closely with data engineering, AI/ML, analytics, clinical, and business teams to support solution delivery
Support operational reporting, dashboards, analytics products, and AI model consumption
Work with healthcare data standards and messaging formats, including HL7 (v2/v3) and FHIR
Apply and validate industry-standard coding systems: ICD-10, CPT, HCPCS, LOINC, SNOMED CT, RxNorm, NDC codes
Handle structured, semi-structured, and unstructured healthcare datasets (e.g., flat files, JSON, XML)
Prepare curated datasets for descriptive, predictive, and prescriptive analytics

Fulltime

Testing & Computer System Validation Specialist

The Testing & Computer System Validation Specialist role involves ensuring compl...

Location

Canada , Ottawa

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

5–8 years of hands-on experience in Testing and Computer System Validation within the Healthcare / Life Sciences domain
5+ years of strong practical experience with IQ, OQ, and PQ execution
5+ years of in-depth knowledge of CSV methodologies and regulatory standards (FDA, GxP, GAMP 5)
5+ years of experience validating systems such as LIMS, QMS, ERP, EMR, or Clinical systems is a plus
Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field

Job Responsibility

Plan, execute, and document Computer System Validation (CSV) activities in compliance with regulatory requirements (GxP, FDA, EMA, etc.)
Develop and review validation deliverables including Validation Plans, Risk Assessments, IQ, OQ, PQ protocols, Traceability Matrices, and Validation Summary Reports
Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for computerized systems
Execute manual and automated testing activities aligned with validation requirements
Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity principles (ALCOA+)
Collaborate with cross-functional teams including Quality, IT, Business, and Vendors
Support audits and inspections by preparing validation evidence and responding to audit queries
Participate in change control, deviation management, CAPA, and periodic reviews of validated systems
Provide guidance and mentorship to junior validation/test team members as needed

Clinical Development Specialist – Diagnostics

We are seeking an enthusiastic and detail-oriented Clinical Development Speciali...

Location

Malaysia; Singapore , Kuala Lumpur; Singapore

Salary:

Not provided

ResMed

Expiration Date

Until further notice

Requirements

Bachelor’s degree in life sciences, biomedical engineering, public health, or a related field
3+ years of experience in clinical development or clinical research, with a focus on diagnostics, in vitro diagnostics (IVDs), or medical devices
Familiarity with clinical validation and usability studies for diagnostics
Working knowledge of Good Clinical Practice (GCP), ISO 14155, and diagnostic regulatory frameworks
Strong organizational skills and the ability to manage multiple projects simultaneously
Excellent verbal and written communication skills
Highly skilled in stakeholder management across different regions and time-zones

Job Responsibility

Support the planning and execution of clinical studies—including analytical validation, clinical validation, and usability studies—aligned with diagnostic development goals
Assist in developing study protocols, investigator brochures, case report forms (CRFs), and other clinical study documents
Collaborate with internal stakeholders such as Regulatory Affairs, Clinical Operations, R&D, and Marketing to ensure integrated study planning and execution
Liaise with external investigators, clinical sites, and contract research organizations (CROs) to support effective study conduct and data integrity
Participate in data analysis and interpretation activities to support product development, regulatory submissions, and scientific communications
Track study timelines, milestones, and budgets to ensure clinical projects are completed on time and within scope
Maintain a strong understanding of diagnostic regulatory pathways (e.g., FDA, CE-IVD, CLIA) and ensure compliance with applicable clinical and ethical guidelines
Contribute to the development of abstracts, posters, and manuscripts to communicate clinical evidence to external audiences

Fulltime

Clinical Coding Specialist

We're looking for a Clinical Coding Specialist with deep expertise in Australian...

Location

Australia , Melbourne

Salary:

Not provided

Heidi

Expiration Date

Until further notice

Requirements

3-5+ years of professional medical coding experience in Australian hospital, clinic, or health system environments
HIMAA certification in Clinical Coding or equivalent qualification (university/TAFE clinical coding certificate)
Expert-level knowledge of ICD-10-AM/ACHI and Australian Coding Standards (ACS) across multiple specialties
Strong understanding of DRG (Diagnosis Related Groups) and AR-DRG classification system
MBS knowledge and understanding of Medicare Australia billing requirements
Multi-specialty coding experience including public/private hospital, GP, emergency department, and specialty clinic coding
Experience with coding audits and quality assurance processes, including accuracy measurement and improvement initiatives
Familiarity with EHR systems such as Epic, Cerner, Best Practice, Medical Director, Genie, or hospital PAS systems
Analytical skills with ability to identify coding patterns, trends, and systematic issues
Adaptability to work in a fast-paced technology environment and translate traditional coding processes into innovative AI-powered solutions

Job Responsibility

Lead medical coding validation for AI-generated documentation, ensuring accurate application of ICD-10-AM, ACHI, and MBS item numbers across diverse clinical scenarios in both public and private settings
Develop coding guidelines and protocols that translate complex Australian Coding Standards (ACS) into systematic processes our AI can learn and apply consistently
Conduct quality audits of AI-coded documentation, identifying patterns, gaps, and opportunities for improvement in coding accuracy, DRG assignment, and compliance
Collaborate with engineering teams to translate medical coding expertise into technical requirements, validation rules, and system improvements
Work directly with Australian clinicians to understand documentation patterns, clinical decision-making, and coding challenges across private hospitals, and public health systems, and GP practices
Ensure regulatory compliance with Department of Health coding standards, Medicare Australia requirements, DVA guidelines, and private health insurer specifications
Analyze coding data and metrics to identify trends, accuracy patterns, and areas for system optimization across our Australian customer base
Stay current with coding updates including annual ICD-10-AM/ACHI releases, MBS schedule changes, and ACCD standards updates
Support customer implementations by providing coding expertise during enterprise client onboarding and troubleshooting

What we offer

Flexible hybrid working environment, with 3 days in the office
A generous personal development budget of $500 per annum
Learn from some of the best engineers and creatives, joining a diverse team
Become an owner, with shares (equity) in the company, if Heidi wins, we all win
The rare chance to create a global impact as you immerse yourself in one of Australia’s leading healthtech startups
If you have an impact quickly, the opportunity to fast track your startup career

Fulltime

Specialist, GxP Compliance & Data Integrity

Beam is seeking a highly skilled Specialist I/II to join our growing Digital Qua...

Location

United States , RTP, North Carolina

Salary:

105000.00 - 145000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field with 10+ years of relevant experience
or Master’s degree in the same fields with 8+ years of relevant experience
Experience working in Quality Assurance, Validation, or IT Quality Assurance roles within the biotechnology or pharmaceutical industry
Experience working with systems like DeltaV, OSI PI, BAS, Kneat, Veeva, MES or comparable automation and data systems
Familiarity working with manufacturing platforms such as Rotea, Sepax, LOVO, Cue, Prodigy, MaxCyte, Skid Controllers and platform integrations with DeltaV is preferred
Experience with analytical instruments such as Spectramax, Zetasizer, MACSQuant, SoloVPE, BacT with MYLA software, and other laboratory instruments
Experience with supplier management program for computerized system suppliers
Strong operational knowledge of risk-based tools, ALCOA+ principles, FDA and MHRA data integrity guidance, and 21 CFR Part 11/Annex 11 regulations is preferred
Prior experience working as a QA reviewer for embedded computerized systems – manufacturing equipment(s) and analytical instruments
Proven ability to implement cross-functional remediation plans aligned with the regulatory expectations for CSV/CSA and data governance

Job Responsibility

Oversee risk-based Computerized System Validation (CSV)/Computerized Software Assurance (CSA) activities across Manufacturing, QC, IT, Automation and Global Platforms, ensuring 21 CFR Part 11/Annex 11 and Beam’s internal policies and procedures
Support review and approval of validation lifecycle documents including but not limited to SIA, URS/SRS, CS, FDS, IQ, OQ, PQ, RTM and VSR, for embedded computerized systems and global platforms
Support authoring of CSV lifecycle and test documents, risk assessments and gap assessments as required
Collaborate with IT system owners, business systems owners, validation and product quality to deploy robust data integrity controls across systems and processes
Participate in Change Management activities to ensure controlled evaluation, qualification, and deployment of changes
Serve as SME and/or Quality approver on QMS records including change controls, continuous improvements, CAPAs, deviations and supplier qualification associated with computerized systems and data integrity
Review and ensure validation compliance for infrastructure systems such as DeltaV, MES, OSI PI, BAS, Clinical and Cloud systems
Act as data integrity SME by ensuring the enforcement of ALCOA+ principles and identifying critical data risks across manufacturing processes, QC methods, and computerized systems
Actively participate in the development of data integrity gap assessment program and assessment tools and eventual gap remediation activities by supporting identification of short term and long term mitigation strategies
Contribute to improvements in CSV/CSA and data integrity policies and procedures, user/functional group SME training and guidance

Fulltime

Intermediate Application Support Specialist

We are seeking a highly motivated and customer-focused Intermediate Application ...

Location

Canada , Toronto

Salary:

Not provided

Randstad

Expiration Date

August 02, 2026

Requirements

Salesforce Ecosystem Acumen: Strong hands-on experience supporting Salesforce-based applications, with a solid understanding of standard objects, workflows, flows, profiles, permissions, and dashboards.
SaaS Ticket Lifecycle: Proven experience providing end-user support in a cloud-hosted SaaS environment using enterprise incident management systems (e.g., ServiceNow, Jira, Salesforce Service Cloud).
Data Integration & Flows: Foundational understanding of integrated data streams, synchronization issues, and dependency management across distributed systems.
QA & Testing Capabilities: Functional experience writing or executing test scripts, tracking codebase defects, and validating fixes during release support windows.
Customer Service Focus: A strong customer-first mindset with proven patience, strong listening skills, and the ability to manage high-pressure situations and user expectations.
Problem Solving: Strong critical thinking skills to perform error tracing, analyze underlying patterns across recurring incidents, and suggest structural improvements.
Communication Depth: Clear, structured written and verbal communication skills, with a polished ability to explain complex technical configurations simply to non-technical users.
Regulated Domain Awareness: Familiarity working within large structured frameworks or healthcare-adjacent systems (such as EMRs, clinical assessment tools, or long-term care systems) alongside standard privacy principles is highly valued.
Certifications: Active professional credentials, such as a Salesforce Certified Administrator designation, are considered a strong asset but are not mandatory.

Job Responsibility

Application Troubleshooting: Deliver high-tier technical support and root-cause analysis to triage and resolve application data, record validation, and configuration issues within Salesforce environments
Incident & Queue Management: Manage corporate ticket queues, prioritize incoming incidents based on business impact or urgency, and maintain strict adherence to service level agreements (SLAs)
Technical Documentation: Author and maintain technical support documentation, operational deployment guides, known error databases, and searchable knowledge-base entries
Cross-Functional Liaison: Act as a central point of contact between end users and specialized technical streams—such as Database Administrators, Network Engineers, and Security Specialists—to coordinate issue resolutions
System Maintenance & Releases: Support platform upgrade schedules, change management processes, release cycles, and post-deployment validation activities
Reporting & Analytics: Design, configure, and manage standard reports and visual dashboards to deliver actionable data insights to various business units
Quality Assurance Support: Participate in operational quality assurance reviews, executing functional or regression test cases, and supporting User Acceptance Testing (UAT) tracking
User Enablement & Training: Develop and deliver customized technical training, user-friendly how-to guides, and release notes to business users
Operational Compliance: Ensure all solution support activities comply with corporate digital accessibility guidelines and data protection policies

What we offer

Diverse Tech Exposure: Deepen your technical knowledge within the Salesforce ecosystem, cloud-based SaaS integrations, and modern incident management platforms
Professional Growth: Capitalize on an environment that values cross-functional exposure to Quality Assurance, release validation, and deployment tracking
Long-Term Continuity: Secure a stable 15-month foundational contract offering strong career predictability and extension avenues
Structured Environment: Gain experience supporting critical systems while operating within defined compliance, accessibility, and operational excellence standards

Fulltime

Junior Business Analyst

We are seeking a data-focused, motivated Junior Business Analyst to deliver comp...

Location

Canada , North York

Salary:

Not provided

Randstad

Expiration Date

July 27, 2026

Requirements

Healthcare Data Standards: Proven, hands-on experience working directly with FHIR standards, including custom resource modeling, profiles, and FHIR API ingestion patterns.
Technical Data Tooling: Strong capability writing SQL queries paired with practical experience handling data exploration assets inside Databricks.
Data Engineering Literacy: Solid experience executing detailed data analysis, schema profiling, and building source-to-target data mapping templates.
Web Services & Formats: High proficiency generating, reading, and editing JSON files combined with practical API testing using Postman.
Agile Framework Experience: Direct experience working within an Agile/Scrum delivery model leveraging tracking software like Azure DevOps.
Core Business Analysis Skills: Demonstrated ability to document use cases, map business process models, and translate technical data metrics into clear software execution steps.
Soft Skills: Superior analytical, problem-solving, and verbal/written communication skills with a proven track record of successfully collaborating within technical delivery teams under tight deadlines.

Job Responsibility

Data Standards Transposition: Analyze source healthcare records and lead data transformation activities, mapping and modeling legacy relational database structures into standard Fast Healthcare Interoperability Resources (FHIR) schemas.
Agile Requirements Architecture: Extract and clarify detailed technical requirements from clinical stakeholders and subject matter experts. Formulate and structure coherent, technical user stories and acceptance criteria within Azure DevOps.
Technical Interface Validation: Author and manipulate structured JSON payloads. Execute data integration, endpoint verification, and API behavior validation utilizing Postman.
Database Analysis & Ingestion: Write and run targeted SQL queries to profile data distributions, discover schema anomalies, and execute precise source-to-target data mapping matrices.
Cloud Analytics Exposure: Support big data analysis and data validation tracks within unified cloud environments like Microsoft Databricks.
Cross-Functional Communication: Act as a core translator, working closely alongside Software Developers, Data Engineers, and Privacy Specialists to communicate, clarify, and validate dense backend data definitions.
Lifecycle Documentation: Build and maintain detailed business analysis artifacts, including data flow diagrams, business rules registries, and comprehensive requirements traceability matrices (RTM).

Akta Sales Specialist

Bring more to life. Are you ready to accelerate your potential and make a real d...

Location

Korea, Republic of , Seoul

Salary:

Not provided

Danaher Corporation

Expiration Date

Until further notice

Requirements

A Master's degree or higher in Protein Science, Biochemistry, Chemical Engineering, or a related Life Science field is required
A minimum of 5 years of professional experience in the biotechnology or biopharmaceutical industry is highly desirable
Comprehensive expertise in protein purification and characterization is essential
Hands-on experience with AKTA systems, Biacore, and various chromatography resins is highly preferred
A deep understanding of laboratory-scale downstream processes is required
Proven experience in identifying new market opportunities, lead development, and funnel management within the research or clinical sectors
Demonstrated ability to translate technical research needs into strategic business value propositions and drive cross-selling across the protein purification portfolio
Team player
Strong communication and interpersonal skills
Fluency in both English and Korean is essential

Job Responsibility

Drive revenue and order targets for the AKTA business unit through accurate forecasting and strategic pipeline management
While primarily focused on the AKTA business, this role may also manage and support additional products within the Protein Research portfolio based on customer needs and business priorities
Execute Business Unit strategies across operating companies to maximize market share and achieve business objectives within cross-opco accounts
Provide expert knowledge in protein purification to offer optimized workflow solutions, integrating AKTA hardware, UNICORN software, and resin portfolios
Lead technical consultations and workflow assessments to maximize research efficiency for customers in laboratory-scale environments
Proactively identify and collect market insights, including emerging research trends and customer needs in drug discovery and basic research
Develop and implement market expansion strategies based on captured insights to identify and capitalize on new business opportunities
Prospect and develop new sales leads by identifying new research projects, laboratory setups, and government-funded initiatives
Collaborate with Product Management and Marketing to support new product launches and relay voice-of-customer and market feedback
Engage with a diverse customer base, including biotech startups, academic institutions, and national research centers, with tailored value propositions

Fulltime

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Clinical Data Validation Engineer Specialist

Job Description

Job Responsibility

Requirements

What we offer

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