SUMIT SHANSHANWAL

https://www.linkedin.com/in/sumit-shanshanwal-ba7b0911a

Email ID: aczet8@r.postjobfree.com

SUMMARY

A motivated, enthusiastic and organized professional having 3 years of experience in Clinical Data Management.

Broad range of knowledge in data management disciplines and protocols within the healthcare industry.

Strong clinical data management background and competence in clinical trials and related areas with Pharma, and CROs in a clinical research management role.

Highly skilled in developing, applying, and promoting consistent data management standards.

Comprehensive knowledge and experience of working with the Medrio EDC system.

Comprehensive knowledge and experience of study start-up activities, CRF design process and protocol review.

Develop and/or review various clinical documents including those submitted to regulatory agencies. Consistently project and operate within study timelines.

Experience and comprehensive knowledge of SAE reconciliation and third party vendor reconciliations.

Experience of coordinating the data management studies, eCRF design, edit checks specifications/validations, vendor transfer specs review/approval, discrepancy management, monitor and communicate data trends/issues and execute resolution(s), provide routine project status updates to all levels of management.

Experience performing data review and delivering clean datasets to Bios for analysis/soft DB lock/hard DB lock in accordance with protocol, SOPs, internal/external guidelines;

Knowledge in medical dictionaries; MedDRA and WHOdrug dictionaries.

Trained in Medidata Rave and InForm.

Successful in leading a clinical study from protocol development through database lock.

Comprehensive knowledge in ICH-GCP and 21CFR rules and regulations and very good understanding of Part 11 compliance, EDC Systems and Computer system validation requirements.

Significant training, continuing education and knowledge of regulatory requirements and ICH and GCP guidelines.

Skilled at learning new concepts quickly, working well under pressure, and communicating ideas clearly and effectively.

Excellent written and verbal communication skills.

SOFTWARE SKILLS

Medrio EDC (version 34)

Edc2go

MS Office – Word, Excel, PowerPoint

PROFESSIONAL EXPERIENCE

Integrated Resources Inc, CRO Division Oct 2015 – Present

Clinical Data Manager

Primarily performed protocol review with the study team and designed eCRFs in Medrio EDC.

Involved in preparation and review of the Edit Check Specification document.

Created data management plan (DMP) in co-ordination with study team.

Deployed test database to production, and ensure all documentation is complete.

Involved in data cleaning activities such as, data review and generate query; review responses from sites and resolving queries.

Involved in reconciliation of Serious Adverse Events (SAE) data as per SAE plan.

Performed UAT of Edit Checks in Medrio EDC.

Prepared for database lock as per ‘Database Finalization Checklist.’

Responsible for preparing and distributing study progress reports to study team on periodic basis.

Excel Drugs, Brooklyn, NY Jan 2015 – Jun 2015

Pharmacy Technician (Part-time)

Responsibilities were to take care of Inventory management.

Prescription data entry and retrieval and Customer care etc.

Answering the phone calls and handle the cash register.

Helps health care providers and patients by greeting them in person and by phone; answering questions and requests; referring inquiries to the pharmacist.

Maintains pharmacy inventory by checking stock to determine inventory level; anticipating needed medications and supplies; placing and expediting orders; verifying receipt; removing outdated drugs.

Maintains a safe and clean pharmacy by complying with procedures, rules, and regulations.

Organizes medications for pharmacist to dispense by reading medication orders and prescriptions; preparing labels; calculating quantities; assembling intravenous solutions and other pharmaceutical therapies.

Maintains records by recording and filing physicians' orders and prescriptions.

Ensures medication availability by delivering medications to patients and departments.

Contributes to team effort by accomplishing related results as needed.

ICON Apr 2013 – Aug 2014

Clinical Data Analyst

Case Report Form (CRF) development and maintenance.

Edit Check specifications development and maintenance.

Database setup testing and Edit Check programming testing.

Ensure that all data management activities for assigned studies are completed on time and with high quality or escalate as appropriate.

Perform other related duties and responsibilities, on occasion, as assigned.

Ciens Laboratory May 2012 – Jul 2012

QA/QC Intern

Worked in the quality control and quality assurance department.

Conducted assays on HPLC and UV-Vis spectrophotometer.

Evaluated dissolution study profile of solid dosage forms.

Represent the department in Quality Assurance meetings, co-ordinate in maintaining process documentation, conducting internal audits and assist in finding effective solutions to any reported non-compliance.

EDUCATION/ CERTIFICATION/ TRAINING:

MS in Pharmacy Administration with concentration track of Regulatory Affairs, QA/QC

St. John’s University - September 2014 - May 2016 (GPA: 3.80)

Intellectual Property and Pharmaceutical R&D, Federation of Indian Chambers of Commerce and Industry – August 2014 - January 2015

Bachelor of Pharmacy, Dr. Bhanuben Nanavati College of Pharmacy – June 2010-July 2014

PROJECTS

Drafted all modules of eCTD for drug Movantik.

Analyzed medical device regulations related to classification of medical devices, laws and amendments, marketing, role of ethics, recalls, labeling requirements, post marketing surveillance and IMDRF. Conducted and submitted a comparative study between the laws of the United States with those of Canada.

cv...question like yourself brief but concrete about yourself...edu back ...job experience...whereeveer possible give examples...uat in 2 phases crf screen review...2nd edit check testing crf screen review...for study...30 standard scren...15 specific study...whether 45 crfs are developed as per crf bases...crf development team...as whether data has been filled crf data...medical h...data flow is accurately positioned in the database...cycle 1 data also in parallel database is ready...tell in examples start putting all examples real self...whatever information...it's not about cur...gcp phase 1 to 4...cdisc...cdash...lgtm...ig gcp...brush through monthly meetings project update sr. data manager interacted with the sponsor...safety department at sponsor...monthly sae listing from ARGUS you used to reconcile SAE reported in clinical database relationship…key parameters are matching….site no and subject no…sae preffered term…in both the data base they use medDRA…severity…causality...relationship with the study drug…sae reconciliation tracker…this tracker is an excel file…biweekly basi with cra team for query

the studies we wroked on are as per sdtm standards...and often...used to coordinate with sdtm team programming teams sdtm are standards we work closely with sdtm team to make sure whatever is requested for adaata review by clinical team...data management team...ecrf development team...coding team...we are data managers...we provide crf bases...ecrf build crfs and edit checks...coding team is responsible for review data as per the 2 dictionaries...sat programming team...1 is ecrf programming team...design from dm team...sdtm programming team is from sat...CDISC...there is no practical concept you can tell...for studies...all studies were CDISC Compliant...when i worked in novartis...init 2008-2009, own standards for study design...they used to convert whenever data is right from data analysis to collection...there is no additional team required.every company has biostats biostat B and Statistical reporting SR - team also SDTM send it to biostats for analysis

here include...what is your real experience...crf review created crf bases...performed uat...performed ...tells about different aspects what you have worked on...site number is useless restrict to 3-4 minutes..why

for other project doing this, this, this...last 3-4 months or 6 months...don't focus on other projects...summarize multiple projects...project A..study start up...Study review...Multiple projects

sae reconciliation is complete, protocol deviations review are complete (reviewed by SAT and clinical team) and before database coding reconciliation is done.

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