Clinical Data Management is the fields which transform raw data into consistent, accurate, reliable, meaningful trial output in accordance with guidelines. Market is expected to grow to US$1.37 billion by 2015. Driving factors for growth of this segment are advancement in e-technologies, continuing technological advancements and globalization of clinical trials. CDM market size is considered to be >US$60 million growing at a rate of over 50%. There are over 150 organizations active in this segment.
Professionally trained personnel are required to sustain in such challenging environment. IGMPI provides theoretical as well as practical knowledge which provides assurance of sustainability and success in this industry.
The programme is meant for Graduates and Post Graduates, employed plus yet to be employed candidates keen on taking Data management as their career choice.
After completion of this programme, students will have clear understanding on various essential elements of clinical data management, theoretical knowledge on regulatory guidelines, CDM work flow, data management plan, different activities involving CRF designing, data entry, data collection, AE management, report creation etc. along with roles and responsibilities of CDM personnel.
Module 1: Introduction to Clinical Research, Roles & Responsibilities of Key Stakeholders
Module 2: Preparations, Planning for Clinical Trials and Essential Documentation in Clinical Research & Regulatory Submissions
Module 3: Introduction to Data Management
Module 4: CRF Design Considerations
Module 5: Data Entry, Remote Data Entry
Module 6: Identifying and Managing Discrepancies
Module 7: Data Management Plan
Module 8: Electronic Data Capture
Module 9: Tracking CRF Data
Module 10: Managing Lab Data
Module 11: Collecting Adverse Event Data
Module 12: Creating Reports and Transferring Data
Module 13: Virtual Clinical Trial (Role of Artificial Intelligence (AI) and Machine Learning (ML))
Module 14: Case Studies
Any Graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.
Minimum duration to complete this programme is 3 months and maximum is 6 months.
The registration dates for this programme run by the Institute are updated timely on the webpage. Effective online learning tools incorporated into the design of the webpage make the programme lectures, online live classes and study material easily accessible. This gives a huge window of self-regulated and self-paced performance to the participants.
A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.
IGMPI follows a credit system based on all learning activities involved in studying for all PG Diploma, Executive Diploma and Certificate Programmes. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme.
All the participants are obliged to timely submit completed assessment assignments (during the programme, usually after every module) and appear for an online exam at the end of the programme. After successful completion, the participants will be awarded Industry Certificate in Clinical Data Management by Faculty of Clinical Research, IGMPI. For all the above mentioned modules elaborate programme material, self-assessment assignments and project work details would be provided by the Institute from time to time. Details get updated on the webpage as well.
The Institute has partnered with many organizations for providing with placement assistance to in its participants. The robust placement cell comprises of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. We are engaged in promoting the employability of our participants by maintaining good rapport and relation with HR cell and recruiting managers of leading healthcare companies across the globe.
The efforts of our placement cell also include helping with professional resume writing, interview skills & conducting mock interviews etc.
In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare like Dr. Reddy’s Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, Ipca Laboratories, Calyx, Bliss GVS Pharma, Accenture, Wipro, Fortis Clinical Research, Quintiles, SeQuent, Mankind, Beryl Drugs, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Biocon, Apollo Hospitals, etc.
Clinical Data Management (CDM) has long way with increased importance within and outside biopharmaceutical research and development. Specific skills include the development of electronic case report forms, data management plans, data review and reconciliation. Major companies hiring clinical data management professionals are CTS, TCS, PPD, BMS, Pfizer, Accenture, ICON, Novartis, Quintiles, Parexel, Neeman Medical etc. This programme provides person, professional benefits such as sense of accomplishment, validation of CDM knowledge, recognition by company, ability to train others as well as assisting others and organizational benefits such as well trained and updated professionals, excellent professional development opportunities with increased efficiency and improved quality within the company. This programme ensures a professional career in the clinical research industry as a Case Report Designer / Clinical Data Quality Assurance/ Quality Control/ Clinical Data Associate etc. in pharmaceutical/biotechnology sectors, CROs, etc.
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All existing and old students and training participants are requested to write to our Corporate Resources division on info@igmpi.ac.in along with your updated resume mentioning their Enrollment No. for registration with our Placement Cell asap, if not registered yet.
Moderated by Shri Vinod Arora, Principal Advisor, IGMPI
Moderated by Shri Vinod Arora, Principal Advisor, IGMPI
Moderated by Shri Vinod Arora, Principal Advisor, IGMPI
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