Nimish Dudhatra
Freelance Clinical Research Consultant (Site & Study Management, Medical Writing, Audit & Monitoring)
- Role
- Head Clinical Operations at Concept Clinical Service
- Location
- Surat, GJ, IN
- LinkedIn followers
- 500 followers
About Nimish Dudhatra
I have good network of Investigators with good site set up at Surat. All are highly…
Experience
Head Clinical Operations
Jun 2010 — Present
I have good network of Investigators with good site set up at Surat. All are highly motivated for research and leaders in their specialist and having good number of patient pool-Independent Monitoring-Auditing-Medical Writing-Complete Management of Study-Finding New Studies-Identification of New and Potential Investigator based on study-Site Feasibility-Site Set-up-SOPs Preparation-Regulatory/EC Submission and Communication-communication with Sponsor/CRO/SMO-Liaise with Pharmacy-Liaise with Central/Local Laboratory-Patient Recruitment follow-up-Data Entry / CRF Completion-Query Resolution-Reporting AEs and SAEs-Manage and update SMF/TMF-Assist Investigator to conduct Study as per Protocol, ICH – GCP and applicable regulatory authorities.
Education
South Gujarat University
B. Sc, Medial Technology
2004 — 2007
ICRI
PGD, Clinical Research Management
2007 — 2008
BII Noida
Industrial Program, Pharma Regulatory Affairs
2008 — 2009
Cranfield University UK
Msc, Clinical Research
2007 — 2009
Skills
- Management
- Clinical Trials
- Healthcare
- Medical Writing
- Ich-Gcp
- Patient Recruitment
- Clinical Data Management
- Pharmaceutical Industry
- Sop
- Gcp
- Protocol
- Clinical Research
- Nephrology
- CRO
- Edc
- Pharmacology
- Ctms
- Crf Design
- In Vivo
- Good Clinical Practice (Gcp)
- Clinical Monitoring
- Clinical Trial Management System (Ctms)
- Electronic Data Capture (Edc)
- CRO Management
- Standard Operating Procedure (Sop)
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