PUNE · FULLTIME
Clinical Data Management Trainer
Aspire Techsoft
Pune · onsite · Posted 13d ago
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Section · 01
About this role
- Deliver training on Clinical Data Management topics including:
- Introduction to Clinical Research Clinical Data Management
- Clinical Trial Data Flow Data Management Processes
- Clinical Data Management (CDM) Principles Best Practices
- EDC (Electronic Data Capture) Systems
- CRF/eCRF Design Development
- Data Entry Data Validation
- Edit Checks Query Management
- Medical Coding - MedDRA WHODrug
- Data Cleaning Data Reconciliation
- SAE/AE Data Review and Reconciliation
- Database Lock Data Finalization
- Clinical Data Review
- Data Management Plan (DMP)
- Data Validation Plan (DVP)
- CDISC Standards - CDASH, SDTM ADaM
- Clinical Data Management Guidelines Regulatory Requirements
- GCP and applicable regulatory guidelines
- Practical CDM case studies and real-world scenarios
- Conduct practical training sessions, case studies, and hands-on exercises.
- Prepare training materials, assignments, assessments, and mock tests.
- Train freshers and working professionals in Clinical Data Management.
- Explain real-world clinical trial data management processes and workflows.
- Evaluate learner performance and provide constructive feedback.
- Conduct online and classroom training sessions as per the schedule.
- Guide learners on industry practices, documentation, and CDM career opportunities.
- Share practical knowledge of EDC systems and clinical data management tools.
- Strong knowledge of Clinical Data Management processes and clinical trial workflows.
- Good understanding of EDC systems and clinical databases.
- Knowledge of CRF/eCRF, edit checks, query management, data cleaning, and database lock.
- Familiarity with MedDRA, WHODrug, and CDISC standards preferred.
- Understanding of GCP and clinical research regulatory requirements.
- Good communication, presentation, and teaching skills.
- Ability to train both freshers and working professionals.
- Practical industry experience in Clinical Data Management preferred.
- Qualification:
- Graduate/Postgraduate in Life Sciences, Pharmacy, Biotechnology, Nursing, Clinical Research, or related discipline.
- Minimum 2+ years of experience in Clinical Data Management.
- Prior training/teaching experience preferred.
- Hands-on experience with EDC/CDM tools preferred.
- Experience with CDISC standards and medical coding is an added advantage.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
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Section · 02
Skills
Section · Company
About Aspire Techsoft
Aspire Techsoft
Education & Training
11
employees
2011
15 years old
Pune,Maharashtra
India
₹4.3L PA avg
Avg at Aspire Techsoft
About
Aspire techsoft,Established in 2011, we are the Information Technology Training division of Aspire Techsoft Academy is a reputed IT training institute in India that strives to make IT education easily accessible to students and professionals. We are ranked among the Best Software Training Institutes in India.
We are SAS Authorized Training Institute in Pune. We specialize in SAS, ERP, SAP, Full Stack Development, JAVA, .NET, Data Warehousing, Cloud Computing, Informatica, Abinitio, etc. Over 10000+ Retail, and corporate candidates trained. More than 170 corporate clients. ISO certified Training and development center. We offer globally accepted certifications from SAS.
Our students master the skills for IT Infrastructure Management, followed by On-Job industry training and stipends. Our training opens doors to exciting careers in technical support, facility management, projects, and marketing management. Our training methodologies are standard and will find uniqueness. The process we follows theoretical and practical Training and live Project scenarios, we offer sandbox, development server access the candidate
Our proficiency lies in identifying your talent, understanding your aptitude, analyzing your needs, and nurturing you to reach the zenith of technical excellence. We believe in the innate potential of each individual. Our alumni have been promoted from junior executives to team leaders, project heads, and management professionals over the years.
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