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Clinical data management

Posted on: 2011-01-15

NEETA R. DASS

 

Skills:

  • Good writing skills 
  • Leadership qualities
  • Self-motivated
  • Disciplined and hard working
  • Versatile and good at communication
  • Self-initiator and an able problem solver.

 

Job Experience

 

TOTAL EXPERIENCE: 2.5 years

 

Have worked in all the 3 stages in Clinical Data Management – Study start up, Discrepancy Management and Study close out

 

  • Working presently in Tata Consultancy Services (TCS - Mumbai) as a Senior Process Associate.

            Currently handling projects independently on EDC-MACRO (Electronic Data

            Capture) application.

-         Handling all the discrepancies, including lab discrepancies

-         Taking up tele conferences for the assigned countries individually

-         Preparing Minutes of meeting

-         Performing QC activities

-         Preparing locking memos at the time of database lock

 

  • Worked in Clininvent Research Pvt. Ltd (Mumbai) for 1.5 years as a Biometrician till April 2010.

Have worked on both oncology (metastatic breast cancer) and non-oncology projects (diabetes mellitus, psoriasis, chronic renal failure, coronary artery disease and anogenital warts)

-         Tracking of Case Report Forms (CRF)

-         Enrollment of patient’s data in database

-         Data entry (Double data entry)

-         Raising queries during data entry

-         Checking of data compliance

-         Doing key changes in database

-         Updating Data Clarification Form (DCF) status

 

 

 

-         Preparation of Data Management Study File:

                        - Preparation of Data Management Plan

                        - Preparation of Self Evidence Correction Guidelines / Study Assumptions Document

            - Annotation of CRF 

  • Project done ( Air  monitoring  in  association  with  Thane  Municipal  Corporation ) during my graduation (FYBSc and SYBSc)
  • Mushroom Cultivation workshop (Cultivation of mushroom was taught practically).

                                               

Academic Qualification

 

1) 1 year Post Graduate Diploma in Pharmaceutical Management (PGDPM), Garware Institute of Career Education and Development (GICED), Mumbai University in 2008

 

2) Graduation (Microbiology) from Smt. CHM college, Mumbai University in March 2007

 

3) HSC from St. John the Baptist Jr. college, Mumbai University in March 2004

 

4) SSC from Holy Cross Convent High School, Mumbai University in March 2002

 

Professional Course

 

  • Advanced Certificate Course In Clinical Research ( ACCCR), Smt. CHM college,

            Ulhasnagar, Mumbai, January 2008

  • Certificate of Team Building Workshop
  • Certificate of ICH GCP
    • MSCIT (Maharashtra State Certificate Information Technology - Basics) with 88%.
    • Certificate on Mushroom Cultivation

                                               

Co- Curricular activities and achievements                


      ●    Attended seminars on Clinical Research in association with ICRI

  • Presented seminars/presentations on the following topics:
  1. Schizophrenia
  2. Osteoporosis
  3. AIDS
  4. Regulatory Affairs in Indian Pharmaceutical Industry
  5. Common Technical Document (CTD)
  6. Bioavailability / Bioequivalence studies  (BA/BE)

Personal Details                    

 

Date of birth     :  27th April 1986

Nationality        :  Indian.

Gender             :  Female                     

Marital Status   :  Single.

Languages        :  English, Hindi, Marathi and Bengali.

 

Declaration:

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

Place:  Mumbai