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Dear folks,

I am planning to do consulting from India, I would like to hear from this forum about how we can start, tips and tricks, dos and don’ts etc . given below is my professional summary.

 Certified SAS Advanced Programmer around 7 years of experience in Analysis, design, development, testing and validating the applications.
 Two years of experience on Pharmaceutical industry for Clinical trails, registry setup, submission of trail outcome to FDA in US.
 More than One Year of experience on Banking industry for Basel II and Credit Risk Management.
 Strong knowledge involving all phases (I-IV) of clinical trials.
 Worked on SAS/Base, SAS/Stat, SAS/Access, SAS/Graphs and SAS/Macro under Unix/Windows platform
 Expertise in analyzing and coordinating clinical trial data, generating reports, tables, listings and graphs.
 Knowledge of CRF-Annotation with respect to various database designs.
 Knowledge of CRT Dataset creation from clinical trial data for regulatory submissions.
 Reporting computer validation inspections in compliance with 21 Code of Federal Regulations (21CFR, Part II).
 Involved in performance tuning for large database (~48TB) ETL process.
 Involved in writing and updating Standard operating procedures (SOP) for reviews and approvals.
 Experience in Ad-hoc programming for clinical and data management departments.
 Knowledge of Programming languages such as C and UNIX SHELL.
 Highly motivated individual with excellent organizational and interpersonal skills.
 Possess strong ability to quickly adapt to new applications and platforms.
 Good team leader with strong analytical and communication skills.
 Having experience in leading multicultural team with team size of 12 resources with maintaining his own deliverables and worked with US and Europe clients as interface to offshore and onshore module for more than 2 years

If some one give valid inputs that will be great.

Regards,
Vijay

Tags: Clinical, trials

Views: 84

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Replies to This Discussion

Hi Vijay,

Your profile is impressive & suggest it could be an asset to any of the organisation. Let me put forward few of my point of view may contribute & enable for a start up.

1. Why India. (When you are experienced & exposed to global, US & European market).
2. What is the size of the addressable market in clinical trial Business in India.
3. What is the area you will extend your consulting (CPO, KPO, BPO).
4, Clinical Trials is one of the labour intensive,where revenue is generated through manpower outsourcing in large numbers) & your experience is limited to managing a very small team.
5. In India financial market is more over regulated by Govt. so compliance business is not more promising in India.
6. Your exposure to Tools are limited to SAS which seems to expensive, why a customer will deploy or ousourced when SAS programmer are available in large numbers with a moderate salary p.m.

These are few concern should be adressed with more clarity & conviction before venturing in to of your own.If we could be any of your assistance please let us know.

Thanks !
Biswajit.

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