Company: Pride Circle
Location: Bangalore
Position: Clinical Data Management Intern
Salary: ₹300,000 to ₹600,000 per year
Experience: 0 Years / Freshers
Qualification: B.Pharm, M.Pharm
About the Company
Pride Circle is offering an exciting internship opportunity for freshers in Clinical Data Management. This role is based in Bangalore and comes with a competitive compensation package.
Position Details
| Position Name | Clinical Data Management Intern |
|---|---|
| Organization | Pride Circle |
| Location | Bangalore |
| Salary | ₹300,000 to ₹600,000 per year |
| Experience | 0 Years / Freshers |
| Qualification | B.Pharm, M.Pharm |
Objectives
- Oversee the collection, validation, and processing of clinical trial data.
- Develop and implement data management procedures for clinical trials.
- Support the review of medical coding for validity and completeness.
- Ensure compliance with regulations, protocols, and SOPs in India.
- Maintain high data quality standards throughout the data lifecycle.
- Stay updated on industry best practices, technological advancements, and regulatory requirements.
Responsibilities
- Develop and maintain data management documentation, including study protocols, CRFs, and data management plans.
- Design CRFs and EDC systems for data collection.
- Perform data entry and cleaning activities, including discrepancy management and query resolution.
- Conduct data validation checks and implement quality control measures.
- Develop and execute SOPs for approval, data entry screen design, and validation check testing.
- Collaborate with study team members to resolve data-related issues and discrepancies.
- Generate and review data listings, summaries, and reports for clinical study reports.
- Serve as a primary or backup resource for data management issues.
- Ensure compliance with guidelines, GCP, CDISC standards, and other relevant regulations.
- Contribute to the development and validation of data management software tools.
Required Skills and Qualifications
- B.Pharm or M.Pharm fresher candidates.
- 0-1 years of experience in clinical data management or a similar role in the pharmaceutical or clinical research industry.
- Strong understanding of clinical trial processes, data management principles, and regulatory guidelines.
- Proficiency in EDC systems and clinical data management software.
- Familiarity with relevant regulations and guidelines, like GCP and CDISC standards.
- Knowledge of industry-standard data analysis and reporting software, such as SAS, SQL, and/or Oracle Clinical.
- Excellent attention to detail with problem-solving and analytical skills.
- Strong organizational and time management abilities.
Preferred Skills and Qualifications
- Certification in clinical data management (like CCDM).
- Knowledge of CRF design, MS Project, and analytical capabilities.
- Knowledge of CDISC standards and data interchange formats (e.g., SDTM, ADaM).
- Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).
- Understanding of data privacy and protection regulations (e.g., GDPR).
- Effective communication and interpersonal skills to collaborate with other teams.
Apply now to kickstart your career in Clinical Data Management with Pride Circle!