Clinovo

Position: Senior Medical Coder OVERVIEW Experienced Senior Medical Coder, specializing in MedDRA and WHODrug coding and Serious Adverse Event (SAE) Reconciliation. Proficient in navigating complex medical terminology, collaborating with cross-functional teams, and adhering to industry standards. Proven ability to contribute to the precision and consistency of coded data, ensuring patient safety and compliance with regulatory requirements. Adept at collaborating with cross-functional teams, implementing quality control measures, and contributing to the successful execution of clinical research. KEY TASKS & RESPONSIBILITIES Function as a Coding and SAE subject matter expert providing guidance to clients on best practices, technology, and innovative solutions Design and maintain Medical Coding Guidelines and Serious Adverse Event reconciliation plans in collaboration with sponsors Execute precise and consistent medical coding following coding guidelines and utilizing MedDRA and WHODrug dictionaries Conduct reviews for coding accuracy and consistency reviews including the approval of coded terms and synonym lists Enforce a versioning strategy and timeline for routine updates of industry standard dictionaries (MedDRA and WHODrug) in alignment with medical coding guidelines Assist in maintenance activities for coding tools, including User Acceptance Testing (UAT) script creation and execution Perform testing of coding tool and deployment of Coding /SAE listings in elluminate Ensure adherence to eClinical Solutions/industry quality standards, regulations, guidelines and procedures Perform serious adverse event reconciliation across clinical trial databases, safety systems and other relevant sources Generate coding/SAE queries as necessary Collaborate with safety, clinical, and data management teams to resolve discrepancies and ensure accurate representation of medical coding and safety information Document coding decisions and justifications for clarity and auditability Other duties as assigned Education & Experience Bachelor’s degree in relevant health science or professional qualification in a relevant scientific/technical discipline. 8+ years’ experience in the Pharmaceutical/Biotechnology industry with medical coding experience using WHODrug and MedDRA preferred Knowledge of industry standards, ICH guidelines, and regulatory requirements for medical coding Professional Skills Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology Excellent verbal and written communication skills Detail oriented, ability to multitask with strong prioritization, planning and organization skills Proven ability to work both independently and in a team setting Technical Skills Proficiency in Microsoft Office Applications Experience working on EDC systems. Medidata Rave Coder experience desirable.

Senior Sitecore Developer / Technical Lead role: Core Expertise: Programming: Strong skills in C# and .NET (wide expertise, including Core .NET development). Frontend Development: Next.js, React.js used for dynamic, scalable web applications. Database Management: Proficiency in SQL Server for managing structured data. Sitecore Send & Digital Marketing Tools: Experience with Sitecore Send for marketing automation, along with any other digital marketing platforms. Cloud & APIs: Working knowledge of Azure APIs , Sitecore CDP, and backend jobs in Sitecore-managed Azure cloud. Modern Web Development: Familiarity with GraphQL , Node.js, TypeScript, and state management tools like Redux. Optimization: Ensuring websites perform well across multiple devices, languages, and browsers. Key Responsibilities: Develop scalable web applications and backend marketing automation jobs. Optimize UI/UX using modern frontend frameworks. Work with APIs to integrate microservices. Manage Sitecore-based digital campaigns and data analytics. Ensure high-quality code through test-driven development (TDD). Soft Skills: Strong problem-solving and analytical thinking. Ability to lead and mentor junior developers. Excellent communication and teamwork. Preferred candidate profile

Clinovo is currently seeking a Clinical Data Managers for one of our clients. TITLE : Clinical Data Managers LOCATION: Bangalore Primary Job Function Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. Perform role of Data Team Lead (DTL). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents. Core Job Responsibilities Client Management: Serve as primary point of contact for customer on data management deliverables With minimal guidance, provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise With guidance, provide input for and perform direct negotiations with customer, e.g., timelines, financial, process, resources Maintain strong customer relationships Service Management: Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders With minimal guidance, support DM service delivery with comprehensive DM process and technical expertise in executing projects. Serve as the escalation point for unresolved data issues with guidance, work with client data managers, vendors, internal team members for resolution Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables With guidance, create and/or review and sign-off on all data management plan (DMP) documents Implement proactive quality management plan. Identify any service and quality issues with agreed upon specifications per the DMP and contract/SOW and work with functional manager(s) to resolve With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions Continuously look for opportunities to improve efficiency of tasks and quality of deliverables Identify compliance issues and work with functional manager(s) to ensure timely follow-up and resolution With guidance, maintain internal tracking databases and systems Financial Management/Business Development Support: With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW) Manage SOW/budget Review financial reports monthly and participate in project reviews as requested Identify out of scope tasks and track change orders to completion With guidance, may serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing With guidance, participate in and support RFP process (review RFP documents, pricing, attend bid defense) Other: Provide input on DM process improvements or project solutions to CDM team/CDM department Provide input on the development and implementation of a new technology or tool Participate in a focus team or global or local best practice team Perform other duties as directed by functional manager(s) Preferred Skills and Experience: Previous experience and proven competence in managing study delivery through full DM life-cycle (at least 1 medium Phase III). Demonstrated data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology). Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Knowledge of Good Clinical Practices and applicable regulatory guidelines. Excellent communication, interpersonal, customer service, and teamwork skills. Excellent organizational and problem-solving skills. Excellent project management skills. Ability to work with minimal supervision, using available resources, e.g., functional managers, senior DTLs. Comprehensive understanding of clinical drug development process. Ability to establish and maintain effective working relationships with coworkers, managers, and customers. Previous experience and proven competence in managing study delivery through full DM life cycle (at least 1 medium Phase III). Demonstrated data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology). Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Knowledge of Good Clinical Practices and applicable regulatory guidelines. Excellent communication, interpersonal, customer service, and teamwork skills. Excellent organizational and problem-solving skills. Excellent project management skills. Ability to work with minimal supervision, using available resources, e.g., functional managers, senior DTLs. Comprehensive understanding of clinical drug development process. Ability to establish and maintain effective working relationships with co-workers, managers and customers. Minimum Education: Bachelor's Degree Health, clinical, biological, or mathematical sciences, or related field Required. Role & responsibilities Preferred candidate profile

OVERVIEW: · The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing. · comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases. · The CDM is recognized as the platform expert, leveraging cutting-edge tools and technologies to provide continuous data insights and ensure the timely delivery of high-quality results for Sponsors. · The CDM has a strong foundation in clinical data management, combined with the agility to adapt as processes evolve towards the integration of clinical data science. KEY TASKS & RESPONSIBILITIES · Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools. · Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance. · Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables. · Perform holistic data review and trending analysis via reporting and elluminate® analytics to proactively identify issue, risks and develop mitigation strategies. · Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data. · Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager. · Perform Query Management. · Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate® Data Central for data cleaning strategy and oversight activities. · Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle. · Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate® Data Central with analytics modules. · Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness. · Collaborate and work as a team to ensure the deliverables are completed on time with high quality. · Ensure compliance with industry quality standards, regulations, guidelines, and procedures. · Other duties as assigned. CANDIDATE’S PROFILE Education & Experience · 5+ years’ experience in Clinical Data Management preferred. · Bachelor’s degree in a health-related field or equivalent experience preferred. · CCDM Certification preferred. Professional Skills · Strong project management experience and project team leadership skills including work planning, · work delegation and solving complex problems. · Strong analytical and strategic thinking skills. · Detail oriented, ability to multitask with strong prioritization, planning and organization skills. · Excellent collaborative skills. · Demonstrated command of the English language with proficiency in both verbal and written Communication. Technical Skills · Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel. · Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology. · Proficient with EDC and Clinical Data Management Systems. · Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred. · Experience with RBQM methodology preferred. · Exposure to CDISC guidelines and standards.

We're Hiring! TA Executive Location: Hyderabad Experience: 12 Years Are you passionate about talent acquisition and have experience in clinical or pharma recruitment? We're looking for a dynamic TA Executive to join our growing team! What We’re Looking For: 1–2 years of experience in Talent Acquisition Strong understanding of recruitment processes Preferred: Experience in hiring for Clinical/Pharma domain Excellent communication and coordination skills Based in or willing to work in Hyderabad If you’re ready to grow your career in a fast-paced and impactful domain, we’d love to hear from you!

Primary Job Function Responsible for the integrity of the programming/computing solutions for multiple clinical trials (or equivalent) and/or publication activities. In collaboration with the Biostatistician and Senior Programmer, provide programming support to project-level programming deliverables and other adhoc programming requests. Roles and Responsibilities Ensure understanding and compliance with study and project programming standards. Responsible for development of programming specification. Create and Validate Safety and Efficacy Analysis Datasets in adherence with CDISC and client specific standards and maintain quality and accuracy. Create and Validate Safety and Efficacy Tables, Listings and Figures with high quality and accuracy. Create Study specific or general macros and finalize programming specifications/mock-ups. Adhere to programming specifications and study specific requirements, including completion and filing of required documentation. Plan and organize workload to ensure effective time management and adherence to project specific timelines. Proactively plan for and implement effective resource planning, task allocation and tracking of workload in accordance with agreed KPIs and quality standards Trouble-shoot and resolve programming issues in a timely and efficient manner. Ability to work independently and as part of a team environment. Strong problem solving and organizational skills, attention to detail, verbal and written communications skills Desired Candidate Profile Create and Validate Safety and Efficacy Tables, Listings and Figures with high quality and accuracy. Very strong SAS programming skills required in SAS/Base, PROC SQL,SAS/Stat, SAS Macros and SAS/Graph (Base and Advance SAS). Good communications and negotiation skills, ability to work well with others globally.

Clinovo is currently seeking a Clinical Data Managers for one of our clients. TITLE : Clinical Data Managers LOCATION: Bangalore Primary Job Function Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. Perform role of Data Team Lead (DTL). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents. Core Job Responsibilities Client Management: Serve as primary point of contact for customer on data management deliverables With minimal guidance, provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise With guidance, provide input for and perform direct negotiations with customer, e.g., timelines, financial, process, resources Maintain strong customer relationships Service Management: Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders With minimal guidance, support DM service delivery with comprehensive DM process and technical expertise in executing projects. Serve as the escalation point for unresolved data issues with guidance, work with client data managers, vendors, internal team members for resolution Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables With guidance, create and/or review and sign-off on all data management plan (DMP) documents Implement proactive quality management plan. Identify any service and quality issues with agreed upon specifications per the DMP and contract/SOW and work with functional manager(s) to resolve With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions Continuously look for opportunities to improve efficiency of tasks and quality of deliverables Identify compliance issues and work with functional manager(s) to ensure timely follow-up and resolution With guidance, maintain internal tracking databases and systems Financial Management/Business Development Support: With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW) Manage SOW/budget Review financial reports monthly and participate in project reviews as requested Identify out of scope tasks and track change orders to completion With guidance, may serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing With guidance, participate in and support RFP process (review RFP documents, pricing, attend bid defense) Other: Provide input on DM process improvements or project solutions to CDM team/CDM department Provide input on the development and implementation of a new technology or tool Participate in a focus team or global or local best practice team Perform other duties as directed by functional manager(s) Preferred Skills and Experience: Previous experience and proven competence in managing study delivery through full DM life-cycle (at least 1 medium Phase III). Demonstrated data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology). Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Knowledge of Good Clinical Practices and applicable regulatory guidelines. Excellent communication, interpersonal, customer service, and teamwork skills. Excellent organizational and problem-solving skills. Excellent project management skills. Ability to work with minimal supervision, using available resources, e.g., functional managers, senior DTLs. Comprehensive understanding of clinical drug development process. Ability to establish and maintain effective working relationships with coworkers, managers, and customers. Previous experience and proven competence in managing study delivery through full DM life cycle (at least 1 medium Phase III). Demonstrated data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology). Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Knowledge of Good Clinical Practices and applicable regulatory guidelines. Excellent communication, interpersonal, customer service, and teamwork skills. Excellent organizational and problem-solving skills. Excellent project management skills. Ability to work with minimal supervision, using available resources, e.g., functional managers, senior DTLs. Comprehensive understanding of clinical drug development process. Ability to establish and maintain effective working relationships with co-workers, managers and customers. Minimum Education: Bachelor's Degree Health, clinical, biological, or mathematical sciences, or related field Required. Role & responsibilities Preferred candidate profile

Job Title: Senior Report Programmer Department: Clinical Data Reporting / Biometrics / Data Analytics Location: Pan India, Remote Experience Level: 6+ years Position Summary The Senior Report Programmer is responsible for developing, validating, deploying, and maintaining high-quality data review and visualization reports used by clinical study teams for data monitoring, data cleaning, and decision-making. This role requires strong technical programming skills in SAS and SQL , and hands-on experience with data visualization platforms such as JReview, Spotfire, Power BI, Tableau, or Qlik . The candidate will collaborate closely with Data Management, Biostatistics, and Clinical Operations to translate business requirements into technical specifications and deliver automated, standardized, and compliant data review solutions. Key Responsibilities 1 Report Development & Automation Design, develop, validate, and maintain global standard and study-specific clinical data review reports using SAS , SQL , and visualization platforms (JReview, Spotfire, Power BI, etc.). Create patient profiles , safety review dashboards , data listings , and summary reports to support clinical teams. Develop reusable macros , templates , and scripts to ensure consistency and efficiency across studies. Automate report generation and distribution processes wherever feasible. 2 Data Extraction & Integration Extract, transform, and integrate data from multiple clinical data sources including Rave EDC , eCOA , biomarker , and external lab data . Write complex SQL queries and SAS programs to combine and structure data for reporting needs. Ensure data accuracy, completeness, and traceability throughout the reporting process. 3 Quality Control & Validation Perform rigorous QC and peer reviews of reports and programming outputs. Maintain compliance with regulatory requirements (GCP, CDISC, 21 CFR Part 11). Ensure alignment with internal data standards , naming conventions , and reporting templates . 4£ Requirement Analysis & Documentation Collaborate with Clinical Data Management and Biostatistics to understand study-specific data review needs. Translate reporting requirements into technical specifications , data flow diagrams, and validation plans. Document all report logic, assumptions, and design decisions in accordance with SOPs and audit requirements . 5£ Deployment & Maintenance Deploy and manage reports on global reporting platforms (e.g., JReview, Spotfire server). Maintain version control, access permissions, and refresh schedules for live dashboards. Provide post-deployment support, enhancements, and troubleshooting as required. 6£ Cross-Functional Collaboration Partner with Data Managers, Biostatisticians, Programmers, and Clinical Operations teams to deliver end-to-end reporting solutions. Mentor junior report programmers and contribute to the development of best practices , reporting standards , and automation initiatives . Participate in cross-functional working groups focused on data quality improvement and reporting efficiency . Required Qualifications Education: Bachelors or Masters degree in Computer Science, Life Sciences, Statistics, or related field. Experience: Minimum 6+ years in clinical reporting, programming, or analytics within the pharma, CRO, or biotech industry. Technical Skills: Advanced programming expertise in SAS and SQL . Experience with data visualization/reporting tools : JReview, Spotfire, Power BI, Tableau, or Qlik. Familiarity with Rave EDC and other clinical data systems. Understanding of CDISC standards (SDTM/ADaM) and clinical data structures . Soft Skills: Strong analytical thinking and problem-solving skills. Excellent communication and documentation abilities. Ability to manage multiple studies and priorities independently. Preferred Qualifications Experience in global clinical reporting standardization initiatives. Exposure to Python or R for data analytics or automation. Familiarity with data warehousing concepts or ETL processes . Experience working in a regulated environment (GxP / 21 CFR Part 11). Knowledge of drug development lifecycle and clinical trial processes . Key Competencies Attention to detail and commitment to data accuracy. Proactive and solution-oriented mindset. Collaborative team player with leadership potential. Strong time management and accountability for deliverables. Performance Indicators (KPIs) On-time delivery of validated reports. Accuracy and quality of data outputs. Adherence to coding standards and SOPs. Stakeholder satisfaction with reporting solutions. Contribution to process automation and improvement.

Job Title: Senior Full-Stack Developer Location: Hybrid/Bangalore Experience Level: Senior (6+ years) Role Overview We are seeking a highly skilled and adaptable Senior Full-Stack Developer to join our BI Hosting Team . The ideal candidate will bring deep technical expertise across modern web technologies, architectural design patterns, and development best practices. You will play a key role in designing and delivering scalable, high-performance solutions using .NET (C#) and Angular , while contributing to our MicroFrontEnd and MicroServices architecture initiatives. Experience with AI-assisted development tools such as GitHub Copilot and/or Cursor is highly desirable, as we continuously strive to enhance productivity and code quality through modern development techniques. • Key Responsibilities Design, develop, and maintain robust full-stack applications using .NET (C#) and Angular (v10+) . Implement and optimize MicroFrontEnd and MicroServices architectures for scalability and modularity. Participate in Agile/Scrum ceremonies including sprint planning, daily stand-ups, and retrospectives. Collaborate with cross-functional teams including architects, DevOps, QA, and product owners to ensure high-quality deliverables. Maintain code quality, performance, and security standards across projects. Contribute to the design and enhancement of CI/CD pipelines and GitHub-based workflows . Leverage AI-powered development tools (Copilot, Cursor, etc.) to accelerate code generation, debugging, and optimization. Conduct code reviews , mentor junior developers, and promote best practices in coding and architecture. Required Technical Experience 6+ years of professional experience in .NET (C#) development. 4+ years of hands-on experience with Angular (preferably Angular 10 or higher). Proven expertise in MicroFrontEnd and MicroServices design and deployment. Strong understanding of Object-Oriented Programming , SOLID principles , and Design Patterns . Experience with CI/CD pipelines (Azure DevOps, Jenkins, or GitHub Actions). Solid proficiency in GitHub version control , branching strategies, and automation workflows. Hands-on experience using AI development tools like GitHub Copilot and/or Cursor . Strong background in RESTful APIs , Entity Framework , and SQL databases (e.g., Microsoft SQL Server). Familiarity with cloud platforms (Azure or AWS) and containerization (Docker/Kubernetes) is an advantage. Soft Skills & Work Style Excellent communication skills both written and verbal. Strong analytical and problem-solving mindset. Ability to work independently and collaboratively in a fast-paced Agile environment. A proactive and quality-focused approach to development. Strong sense of ownership and accountability .

OVERVIEW: · The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing. · comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases. · The CDM is recognized as the platform expert, leveraging cutting-edge tools and technologies to provide continuous data insights and ensure the timely delivery of high-quality results for Sponsors. · The CDM has a strong foundation in clinical data management, combined with the agility to adapt as processes evolve towards the integration of clinical data science. KEY TASKS & RESPONSIBILITIES · Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools. · Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance. · Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables. · Perform holistic data review and trending analysis via reporting and elluminate® analytics to proactively identify issue, risks and develop mitigation strategies. · Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data. · Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager. · Perform Query Management. · Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate® Data Central for data cleaning strategy and oversight activities. · Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle. · Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate® Data Central with analytics modules. · Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness. · Collaborate and work as a team to ensure the deliverables are completed on time with high quality. · Ensure compliance with industry quality standards, regulations, guidelines, and procedures. · Other duties as assigned. CANDIDATE’S PROFILE Education & Experience · 5+ years’ experience in Clinical Data Management preferred. · Bachelor’s degree in a health-related field or equivalent experience preferred. Professional Skills · Strong project management experience and project team leadership skills including work planning, · work delegation and solving complex problems. · Strong analytical and strategic thinking skills. · Detail oriented, ability to multitask with strong prioritization, planning and organization skills. · Excellent collaborative skills. · Demonstrated command of the English language with proficiency in both verbal and written Communication. Technical Skills · Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel. · Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology. · Proficient with EDC and Clinical Data Management Systems. · Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred. · Experience with RBQM methodology preferred. · Exposure to CDISC guidelines and standards.

OVERVIEW: The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing. comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases. The CDM is recognized as the platform expert, leveraging cutting-edge tools and technologies to provide continuous data insights and ensure the timely delivery of high-quality results for Sponsors. The CDM has a strong foundation in clinical data management, combined with the agility to adapt as processes evolve towards the integration of clinical data science. KEY TASKS & RESPONSIBILITIES Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools. Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance. Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables. Perform holistic data review and trending analysis via reporting and elluminate analytics to proactively identify issue, risks and develop mitigation strategies. Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data. Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager. Perform Query Management. Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate Data Central for data cleaning strategy and oversight activities. Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle. Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate Data Central with analytics modules. Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness. Collaborate and work as a team to ensure the deliverables are completed on time with high quality. Ensure compliance with industry quality standards, regulations, guidelines, and procedures. Other duties as assigned. CANDIDATE'S PROFILE Education & Experience 5+ years experience in Clinical Data Management preferred. Bachelor's degree in a health-related field or equivalent experience preferred. Professional Skills Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems. Strong analytical and strategic thinking skills. Detail oriented, ability to multitask with strong prioritization, planning and organization skills. Excellent collaborative skills. Demonstrated command of the English language with proficiency in both verbal and written Communication. Technical Skills Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel. Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology. Proficient with EDC and Clinical Data Management Systems. Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred. Experience with RBQM methodology preferred. Exposure to CDISC guidelines and standards.