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Why take this Program CliP-DM (Proficiency in Clinical Data Management) ?

Welcome to CliPLab, a training initiative of Cytel. Cytel team in India is growing by leaps and bounds and today Cytel India grows to a team of 400 people spread across current locations in Pune, Hyderabad, Bangalore and Navi Mumbai. Cytel has expanded its delivery from the core SAS Programming and statistics domain to data management, medical writing and Clinical Data Management areas. Cytel’s growth in services will be supported by CliPLab – Cytel’s unique skill development machinery by introducing various other industry focused training and skill development programs. In a newly announced career program titled CliP-DM (Proficiency in Clinical Data Management) spanning over 6 months, we will provide theory and practical training to young graduates/professionals, who are hand-picked to ensure a mix of the right pool of talents with correct aptitude and skill set. CliP-DM is a self-financed Job enabling initiative. The program helps you enhance your credibility as a technical professional by attaining relevant practical and theoretical knowledge.

Why Clinical Data Management ?

India has developed into a super power for IT skills and has become a major hub for contract research. The outsourcing business in various segments is exhibiting promise. Clinical data management(CDM) is one such area which is growing rapidly, accompanied by a variety of players entering into different models of this business. India has taken the lead in scaling up clinical data management infrastructure and provides quality services to global pharma, biotech and medical devices companies. Multinational and national pharmaceutical companies – big and small, are outsourcing their data management activities to India in order to leverage cost and time. The demand for clinical data management is growing steadily over the years in pharmaceutical and healthcare domain. Technology is changing fast and the traditional data management has been replaced with electronic data capture and remote monitoring. But still there is an increased volume of data which need to be collected, programmed, validated and analyzed. This is highly labor intensive and hence outsourcing of those activities have migrated to low cost countries. This situation has resulted in demand for a large number of skilled and trained resources in clinical data management area offering positions such as; Data Entry Associate, Data Coordinator, Data Manager, Data Safety Associate; Data Safety Manager; Team Leaders, Project Managers etc.

The pharmaceutical and healthcare industry offers number of job opportunities for clinical data management professionals. Graduates who have the right skills and aptitude can consider taking up clinical data management as a full-time profession and a valuable career options.

Considering this, CliPLab launched a Certificate program in clinical data management; CliP-DM and welcomes candidates to join this course. This course has foundation modules, core modules and practical modules. At the end of the 6 months, participants should be able to understand the clinical data management principles and Concepts, regulatory standards and data validation guidelines, practical aspects of data handling, safety data management, reporting, medical coding etc.

Duration:

  • 6 months / 72 hours / Weekend Program (3 hrs daily X 24 days).

Eligibility: 

  • Pharmacy (M. Pharm., B.Pharm.,)
  • Life sciences (M.Sc. – Biotechnology, Bioinformatics, Microbiology)

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Program Outline The course would cover the following modules:

No. Topic
Foundation Modules
Module I Clinical Trial Domain Overview
Module II Data Management Overview
Module III Electronic Data Capture(EDC) / Remote Data Capture(RDC)
Module IV Project Management & Planning
Core Modules
Module V CRF / eCRF Development
Module VI Database set-up and testing
Module VII Validation guidelines and programming
Module VIII Query Management
Module IX Data handling conventions
Module X Third Party Vendor Data Management
Module XI Serious Adverse Event Management
Module XII Medical Coding
Module XIII Quality Control
Module XIV Database Lock
Module XV Data Archival & Data Exclusive
Practical Modules
Module XVI Practical Module-I: Preparing Plans & Conventions
Module XVII Practical Module-II: CDMS & Exposure to DM Projects
Assessments- Theory & Practical

Key Benefits for recruiters-

  • Program Tailored to suit the requirements of the industry – the program is part of Cytel’s strategic initiative to build a team of talented professionals to support its business growth.
  • Possibility of quick ramp-up as the candidates are groomed on technical skills, and hands-on experience.
  • Stringent selection criteria to ensure that only serious candidates are admitted.

Key Benefits for participants-

  • A perfect blend of theoretical knowledge, practical training and coaching that helps you to become an experienced professional.
  • Mentoring by the experienced professionals from Cytel and/or industry.
  • Learn from the experts – renowned professionals who command authority in their respective fields.
  • Opportunity to build a highly coveted profile that suits the market characterized by severe shortage of experienced man-power.

Mode of Payment

  • Payment can be done by Cheque/DD/Credit Card/Debit card/Online Transfer.

Placement

  • After successful completion of six months of training, students will be provided placement assistance.