ALFI ALICE ALEX

Piralassery (P.O),

Chengannur, Email: adnzhk@r.postjobfree.com

Kerala. Phone : +91-790*******, +91-940*******

Title : Clinical Data Coordinator

Work Experience : 3 years and 9 months

Relevant Experience : 1 year and 8 months

Skills : SAS 9.4

Current Organization : Navitas Life sciences, Chennai

Previous Organization: Sangrose Laboratories Pvt Ltd. Kerala

Industry : Health care

Highest Degree Held : MSc. Integrated Biotechnology, SPU

Objective:

I am looking forward to obtain a progressive career in Contract research organizations where I can apply my skills and knowledge for helping the growth of the organization as well as my career.

Professional Experience:

Worked in Navitas Life sciences from 5th March 2018 to 13th March 2020 as a Clinical Data Coordinator.

Worked in Sangrose Laboratories Pvt Ltd. From 23rd January 2016 to 18th February 2018 as Trainee Production Chemist.

Professional summary:

Different phases (phase I to ) of clinical trials.

Clinical trials data like Demographics(DM), Adverse Events(AE), Laboratory data(LB), Vital Signs(VS) Disposition (DS) and Medical history (MH) etc.

Good Understanding of 21CFR Part11 and GCPs (Good Clinical Practices) and Familiar with Clinical Terminology.

Regulatory guidance documents such as ICH-E3 and ICH-E9 and understanding of CDISC SDTM (v3.1.2) & ADaM (2.0) data models.

Trained in various data management skills like importing and exporting data from various sources, handling missing values, reading raw data files, creating data structures, handling programming error.

Experience in accessing, managing and storing SAS data files, using DATA _NULL_, SAS formats, informants, functions, merging.

Experience in BASE / Advance SAS procedures like, Proc Import/Export, Proc Print, Proc sort, Proc Report, Proc Format, Proc Contents, Proc Copy, Proc Means, Proc Summary, Proc Transpose /Append/rank /compare, Proc Univariate, Proc Freq, Proc Tabulate, Proc SQL.

Experience in producing reports in various file types such as Text, HTML, PDF, RTF and Excel using SAS/ODS.

Expertise with PROC SQL, SAS arrays and SAS Macros.

Responsibilities:

As Clinical data analyst:

Worked on SAS/Base, SAS/Macro, SAS/Graphs for producing tables, listings, graphs.

Modified existing datasets using data statements such as SET, MERGE and PROC SORT.

Extracted raw data from Excel sheets and created SAS data sets that are required for the project analysis

Cleaning, validating, sorting and merging techniques is done using SAS/Base include Macros.

Used Output Delivery System (ODS) facility to write custom safety reports directing SAS output to RTF and HTML files.

Analyzed data using various statistical procedures like PROC SUMMARY, PROC MEANS, PROC FREQ, PROC REG.

Developed reports using PROC REPORTS, PROC TABULATE and DATA _NULL_.

Developed SAS Macros for data cleaning and reporting.

As Trainee Production Chemist:

Monitor day to day activities in the manufacturing of soft gelatin capsules, hard gelatin capsules, tablets, liquid orals, cream and ointments.

Supervise the day to day production operations in Clofazamine API plant to achieve targeted yield and quality

To ensure and maintain on-line documentation relating to production record and observed deviations as per FDA rules.

To ensure and maintain on-line documentation relating temperature control, humidity control and area cleaning.

Ensure strict compliance with safety guidelines and cGMP in day to day production activities.

Verifies materials and products compliance to the quality standards by executing the specified inspection requirements.

To ensure and maintain the storage of raw materials, finished products and packing materials.

Supervise the blistering and packing of finished products such as tablets, soft gelatin capsules, liquid orals and semi solids.

Technical Skills:

SAS Tools:

SASV9.4,SAS/MACROS, SAS/SQL, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/ODS

SAS Procedures:

Report, Freq, Means, Summary, Univariate, SQL, Transpose, Copy, Contents, Import, Format.

Operating System

Windows 2007.

Office tools

MS-OFFICE, MS-EXCEL

Database

DSG Designer & eCaseLink

Other

OCRDC

Educational Qualifications:

Examination

Board/ University

Year of Passing

Percentage

Master of science in (Integrated) Biotechnology

Sardar patel University,

Gujarat

2015

63

Personal Skills:

●Able to maintain high standard of work, even under pressure

●Good communication skills.

●Willing to explore and learn new things.

●Teamwork, goal oriented work, planning ability to carry out experiments, patience and hard work.

Declaration:

I hereby declare that the information furnished above is true to the best of my Knowledge.

Place: Kerala Yours sincerely, (Alfi Alice Alex)

Contact this candidate