Medical Clinical Research

Summary:

I am a Healthcare professional (Ayurvedic Doctor) with over all 7 years of experience in Clinical Research industry. I had worked as a Business process leader for pharmaceutical projects, Junior Data Analyst in Pharmacovigilance (PV), & Cardiology Associate in clinical trial.

Academic:

Candidate for Master’s in Project Management-

With concentration in Clinical Trial Design: Apr 2016- Jan 2018

Northeastern University, Boston

Post graduate Diploma in clinical Research Oct 2008- Nov 2009

Institute of clinical Research India, Mumbai.

Bachelors of Ayurvedic Medicine and Surgery –

Maharashtra University of Health Science Nashik, India. Sep 2003 -Feb 2008

Professional Work Experience:

Tata Consultancy Services (TCS): as a Business process leader (Mgmt.) Aug 2014 - Apr 2016.

Quality representative for PV, PSUR, Medical writing, SAS & regulatory affairs documentation.

Engage with operation team for Audit & project management review. Assist in GCP & ISO Audit.

Set up new drug safety project handed over by sales team and ensure complete transition.

Process improvement Initiatives, change control, prepare statement of work & contract report.

Prepare CTQ, SLA and track matrix, & project status report fortnightly.

Prepare RCA & CAPA for defects or Service Level Agreement misses for client (Documentation)

Tata Consultancy Services (TCS): as a Medical Reviewer (Project work) Jun 2012 - Aug 2014.

Review of source documentation- clinical trial and post marketing drug adverse events reports.

Medical review: Assess the seriousness, coding, listedness, of the case in Argus safety database.

Upgrade and downgrade the seriousness of case.

Confirm expectedness with reference to CCDS, USPI, SMPC, & IB for clinical trials.

Review narrative for medical sense & completeness of company summary statement

Reviewing queries, identifying SMOC’s (Signal report) & review company summary for increasing the medical cohesiveness in the case & notifying potential SUSAR’s.

Cognizant Technology Solutions (CTS): as a Junior Data Analyst. Jun 2011 – Jun 2012.

Receive information on adverse events and perform duplicate checks and initialize report.

Clinical trial adverse events & post marketing adverse event reports.

Process the individual case safety report (ICSR) in Argus Database within reporting timeline.

Prepare narratives summarizing all clinical details of patient and MedDRA coding.

Work with country safety departments, clinical safety scientist and PV leaders.

Quintiles (CRO): as a Cardiology Associate. Oct 2009 – Jun 2011.

Review protocol, clinical trial phase, and visit schedule. Receive patient eCRF & medical data.

Caliber QTcB Electrocardiogram (ECG) for SAE prepare diagnosis report using safety database.

Diagnose the ECG referring International Conference on Harmonization (ICH-E14) & protocol.

Proper understanding of ICH GCP (Good Clinical Practice) and clinical trial.

Achievements:

Special Achievement -1 (Quintiles) & Qualified in Indian society of Electro cardiology exam.

Certified Green Belt Six Sigma and TCS internal Auditor (Assisted in GCP, ISO, CMMI)

Technical Skills:

Computer Languages:

Statistical Analysis System (SAS 9.3), MS office, MS Project13.

Regulations and Guideline:

USFDA, EMEA, HIPPA, ICH GCP, E14, Schedule Y, IRB, ISO, CMMI

Databases:

ARGUS, Safety information notification application (SINA), SAS 9.3, Electronic data capture (EDC- MEDIDATA RAVE) Database, QECG Build Database, Intake response and Product complaints (IRPC).

Worked on:

EDC clinical trial-eCRF, SAE report processing, ICSR- PMS case processing (PV), Medical reviewer in Argus database, MedDRA- Coding, Narrative & PV-RCA-CAPA

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