Senior Data Analyst/Data Manager Position for Pharma Candidates @ Syngene International

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Incorporated in the year 1994, Syngene International is one of India’s premier contract research and manufacturing organizations in providing customized service. Our services encompasses all across discovery chain: early stage discovery, process development, cGMP manufacturing and formulation development both in the small molecule and novel biologics area.

Job Title – Senior Data Analyst/Data Manager

Location – Bangalore

Experience – 5 – 8 Years

Job Description:

  • Performing Case Report Form (CRF) data review, raising manual queries and Query response updates to the
  • Database according to the relevant guidelines.
  • Preparation of data management plan, CRF filling guideline and Edit check specification.
  • Performing User Acceptance Testing and Validation.
  • CRF designing and annotation based on protocol.
  • Tracking CRFs, Raising DCFs and queries for paper based studies
  • Freeze and lock CRF data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock
  • Acts as Data quality reviewer, upon delegation for specific studies
  • Responsible for quality of data deliverables.
  • Prepare training materials for data management activities and processes as required.
  • Prepare Standard Operating Procedures
  • Maintaining the study folder with all relevant documentation
  • Generating EDC study related reports and providing updates to the management.
  • Writing manual Edit checks and generating reports for data review.
  • Good knowledge on guidelines and regulations eg: GCP, ICH-GCP, 21 CFR Part11 etc
  • Any other responsibilities assigned by the organization from time to time

MINIMUM REQUIRED EDUCATION AND EXPERIENCE:

  • University degree in clinical, biological or mathematical sciences or related fields with a minimum of 4 to 6 years of relevant work experience.
  • Advanced knowledge on Data Management processes and EDC systems like InForm, RAVE etc Oracle InForm
  • Experience is an added advantage.
  • Good communication and interpersonal skills
  • Experience in effectively managing multiple tasks simultaneously.
  • Excellent written and oral English skills

Education –

  • PG – MS/M.Sc(Science) – Any Specialization, M.Pharma – Pharmacy

Click here to Apply Online

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