Clinical Research Data Management
Training and more
The VIARES Clinical Research Data Management program is more than just training.
We aim to improve employability as Clinical Research Professionals for our participants. Our setup enables participants to complete their program next to a full-time job or in a focused effort. On successful completion of this program graduates will have acquired knowledge, skills and competencies to start at an entry level role as Clinical Research Data Science, like Clinical Data Analyst, Clinical Data Coordinator and others.
Enjoy all our services during your program enrollment.
- modules including
- e-learnings
- assignments
- knowledge checks
- VIARES ACADEMY certificate
- GCP certification
- modules including
- e-learnings
- assignments
- knowledge checks
- VIARES ACADEMY certificate
- GCP certification
- Talent Profile to connect you with open jobs
- Talent Days to connect with our industry partners and learn about career opportunities
- Talent Portal to apply for posted jobs available to the Talent Program Community
Program
The Clinical Research Data Management program consists of four modules. You will complete the following learning activities:
- review the e-learning
- submit the assignment
- take the module test
- join the live instructor-led webinars
- take the final exam
Successfully complete all activities to obtain your VIARES ACADEMY certificate.
- Identify concepts in ethical reasoning which may influence our analysis & results from data.
- Understand the process of data curation, & the custodial duty of data science. Learn some essential tools used by data scientists.
- Investigate & manipulate data to learn its metadata, shape & robustness.
- Identify an appropriate chart & present data to illustrate its core characteristics.
- Recognise the importance & process for applying concepts of privacy & anonymity.
- Integrate methods for metadata & archival into data management.
- Investigate data distribution & confidence, & reshape using Pandas.
- Illustrate core analysis with histograms & box plots.
- Determine implications in collection, mining & recombination of open- & digital data.
- Employ methods for presenting data for synthesis & usage, & employing methods for data maintenance.
- Perform techniques in randomness & probability to understand distribution & likelihood.
- Apply histograms, line charts & scatter plots to illustrate probability.
- Acknowledge the privacy & confidentiality issues in data storage & security of personal data.
- Recognise responsibilities & mechanisms for securing data-at-rest & data-in-motion.
- Apply linear & continuous sampling methods to assess normal distributions.
- Plot distributions as normal histograms & continuous curves.
- Background of medicines development
- Research and discovery stage & product development
- Clinical development
- Regulatory submission, Health Technology Assessment, lifecycle management
- ICH GCP and other applicable regulations
- Applicable international and national regulations
- ICH GCP E6 (R2)
- FDA Regulation
- Quality Assurance: Audits and Inspections
- The Study Protocol
- Elements of a Study Protocol according to ICH GCP
- Trial Design
- Methodologies
- Roles and Responsibilities
- Ethics Committees
- Sponsor / Monitor
- Investigator
- Competent Authority
- Identify concepts in ethical reasoning which may influence our analysis & results from data.
- Understand the process of data curation, & the custodial duty of data science. Learn some essential tools used by data scientists.
- Investigate & manipulate data to learn its metadata, shape & robustness.
- Identify an appropriate chart & present data to illustrate its core characteristics.
- Recognise the importance & process for applying concepts of privacy & anonymity.
- Integrate methods for metadata & archival into data management.
- Investigate data distribution & confidence, & reshape using Pandas.
- Illustrate core analysis with histograms & box plots.
- Determine implications in collection, mining & recombination of open- & digital data.
- Employ methods for presenting data for synthesis & usage, & employing methods for data maintenance.
- Perform techniques in randomness & probability to understand distribution & likelihood.
- Apply histograms, line charts & scatter plots to illustrate probability.
- Acknowledge the privacy & confidentiality issues in data storage & security of personal data.
- Recognise responsibilities & mechanisms for securing data-at-rest & data-in-motion.
- Apply linear & continuous sampling methods to assess normal distributions.
- Plot distributions as normal histograms & continuous curves.
Program Dates
We recommend to first join an information webinar, where we provide guidance and tips on how to best take the program.
January 2021
Enrollment | until January 18, 2021 | first come – first serve |
Program LIVE WEBINARS | DAY | TIME |
Kick-Off Webinar & Access to Program opens | January 19, 2021 | START: 5:30 pm CET END: 6:30 pm CET |
BLOCK 1 Introduction to Data as a Science | January 23, 2021 | START: 2:00 pm CET END: 3:00 pm CET |
BLOCK 2 Research & experiments with data | February 06, 2021 | START: 2:00 pm CET END: 3:00 pm CET |
BLOCK 3 Probability, randomness, & the risk of de-anonymization | February 20, 2021 | START: 2:00 pm CET END: 3:00 pm CET |
BLOCK 4 Sampling, data distribution, & secure data custody | March 06, 2021 | START: 2:00 pm CET END: 3:00 pm CET |
Exam Opens | March 08, 2021 |
|
Information can be subject to change without notice.
Expert instructors
Gavin Chait
Gavin Chait
Gavin Chait is a Data Scientist at Whythawk, which specializes in integrated open data consulting, and training for open knowledge, freedom of information, and economic development projects. He spent more than a decade in economic and development initiatives in South Africa. He was a commercial director at the Open Knowledge Foundation, and led the implementation of numerous open data projects around the world. Gavin has twenty years of experience in teaching at all academic levels, and is a passionate advocate for knowledge development through open access to data and freedom of information.
Hear more from your instructor
Who should attend
This program will be of benefit to anyone with a life science degree and first relevant work experience, ideally but not necessary in clinical research or related areas.
Is this academy right for me? We are happy to help you make the right decision.
Email us at academy@theviares.com and we will contact you.
Typical jobs with this skills
You could apply for jobs like:
- Clinical Data Analyst, Clinical Data Coordinator or similar
You can also take this program to broaden your current skills working in clinical research.
Affordable and flexible
Our Programs come at very affordable cost wherever you are in your career.
Nonmember: EUR 299 net | Member: EUR 199 net
Invite your friends with your personal discount code to sign up and get refunded.
Our Programs come at very affordable cost wherever you are in your career.
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