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SHAILESHKUMAR B. PATELAdd: 4160, Great North Road, Glendene, Auckland 0602Mobile: +64 21 072 5018Email ID.: [email protected] Status: Permanent Residence (NZ)
PERSONAL STATEMENT/PROFILE :
A hardworking and determined person having overall 5 years of experience in a Clinical Research Industry (3.5 years as a Clinical Research Coordinator and 1.5 years as a Clinical Data Manager). Equipped with good communication skills, Self-motivation and ability to take the initiative, Ability to work well under pressure, amiability & tolerance makes me a good team player
EMPLOYMENT HISTORY:
Clinical Data Manager (Junior Data Analyst) at Cognizant Technology Solutions India Pvt. Ltd. (Duration Mar, 2014 to Sep, 2015)
Perform all clinical data management activities on the assigned project in a timely and efficient manner.
Perform all activities in scope like Mock CRF (Case Report Form) preparation, CRF completion instructions, Annotated CRF, DVP (Database Validation Plan), Data transfer specifications, for the assigned study.
Perform the User Acceptance Testing Perform Discrepancy Management – issue queries to appropriate stake holders and
close Queries based on the responses. Perform Third party data reconciliation, SAE reconciliation, medical coding, if
required. Perform third party data loading. Assist in maintaining protocol level documentation of data management activities. Provide status reports to the relevant stake holders. Perform database clean and lock activities – if required. Track metrics Prepare the Patient Data Report (PDR) extraction Perform peer review as part of Quality Control Responsible for CRF shipment post PDR
Sr. Clinical Research Coordinator at Life Research Centre and Strategic Business Unit Pvt. Ltd., Surat
Worked as a Sr. Clinical Research Coordinator in Oncology Phase I/II and BA/BE clinical trials (Duration Sep, 2010 to Feb, 2014)
Job Responsibilities:o Overall Management of Clinical trialso Training new CRCs and site staffo Assist Investigator to conduct study as per protocol, ICH-GCP and applicable
regulations
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o Informed consent processo Patient recruitment and follow upo Coordination with Ethics Committee and CROo IMP and study supply accountabilityo eCRF fillingo Query managemento Monitoring conduction of Clinical study and maintain documentation for meeting all
Regulatory Affairs requirementso Preparing site for Sponsor and Regulatory Audit
EDUCATION AND QUALIFICATIONS:
Qualification School/College University/Board Grade (%)
Passing Year
M.Sc. in Clinical Research ICRI, Mumbai. Cranfield University, UK. 56.00 2010
Post Graduate Diploma in Clinical Research Management
ICRI, Mumbai. ICRI, Mumbai. 59.25 2008
B.Sc. in Microbiology B.P. Baria Science Institute, Navsari. Gujarat.
Veer Narmad South Gujarat University, Surat. Gujarat.
58.30 2007
KEY SKILLS:
o Proficient with MS Word, Excel, PowerPoint, Outlooko Self-motivation and ability to take the initiative o Ability to work well under pressureo Able to take on responsibilityo Good organization, with attention to detailo Effective time management in order to meet deadlineso Ability to successfully work together with a virtual team (including international
teams as required) as well as independentlyo Strong leadership abilityo Excellent analytical and Good presentation skillso Ability to negotiate and influence in order to achieve results
CONFERENCES/ SEMINARS/ TRAININGS ATTENDED:
Attended the 4th International Conference on “Global trends in Clinical Research: 2008” at Hotel Intercontinental- The Grand, Mumbai – March 14 – 15, 2008.
Participated in seminar conducted by Department of Microbiology at B. P. Baria Science Institute in T. Y. BSc.
I was the active member of National Service Scheme (N.S.S) during my graduation.
PROJECTS:
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I have performed four-month project (Thesis) for the fulfillment of M.Sc. degree on “Factors affecting success of DOTS therapy and emergence of MDR-TB in south Gujarat”.
PERSONAL DETAILS:
Date of Birth: 23rd January 1985Languages known: English, Gujarati, HindiPassport No.: K5607538Visa Status: Permanent Residence (NZ)
REFERENCES:1. Dhruti Joshi
Cognizant Technology Solutions, IndiaTeam ManagerMob: +91 9930991118Email: [email protected], [email protected]
2. Dr. Sanjay VarmaLife Research Centre, IndiaCEOMob: +91 9586396266Email: [email protected]
I hereby declare that the above written particulars are true to the best of my knowledge and belief.
Place: Auckland (NZ) Signature:
Date:
