- Experience
- 3+ yrs
- Salary
- INR 600,000 – INR 850,000 / year
- Openings
- 1
- Posted
- 3 ore fa
- Work mode
- In office
- Education
- B.Pharma or B.Sc in Biotechnology or Life Sciences
- Eligibility
- Individuals holding B.Pharma in Clinical Pharmacy, B.Sc in Biotechnology or Life Sciences degrees are qualified to apply.
- Resume
- Required to apply
Where you'll work
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Job description
About the Role
WOW Softech operates as a global contract research organization providing extensive clinical development and resource solutions. Serving emerging biotech and pharmaceutical businesses, especially small to mid-sized companies, WOW Softech supports clinical outsourcing needs with expertise distributed across major market geographies including the USA, UK, the Netherlands, Spain, Hong Kong, India, and Australia.
Responsibilities
- Review data listings and manage queries effectively.
- Conduct User Acceptance Testing (UAT) to ensure data accuracy.
- Perform reconciliation of external data such as laboratory and ECG findings.
- Prepare reports tailored to specific study requirements.
- Carry out database freeze and locking procedures.
- Review vendor data transfer agreements and technical specifications.
- Execute quality control checks on data listings and resolve closed queries.
- Maintain proper filing of study documentation within electronic Trial Master File (eTMF).
- Assist with study closeout tasks and any additional assignments.
- Ensure all processes adhere strictly to SOPs, Good Clinical Practice (GCP), and regulatory standards.
Requirements
- A minimum of 3 years of hands-on experience in Clinical Data Management, including at least 2 years handling and reconciling external data like Lab and ECG.
- Practical knowledge and use of Medidata Rave Electronic Data Capture system.
- Background in managing studies through start-up to database lock phases.
- Experience involved with global clinical trials and familiarity with multiple external vendors.
- Good understanding of clinical data management SOPs and regulatory compliance.
- Educational qualifications include a Bachelor’s or Master’s degree in Pharmacy or Life Sciences.
Eligibility
Candidates with B.Pharma in Clinical Pharmacy, B.Sc in Biotechnology or Life Sciences are eligible to apply.
Minimum education
Bachelor's Degree