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
