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About Company

Pride Circle is offering an internship opportunity for the role of Clinical Data Management Intern. The position is based in Bangalore and offers a competitive compensation package ranging from ₹300,000 to ₹600,000 per year.

Position Name :

Clinical Data Management Intern

Organization :

Pride Circle

Qualification:

B.Pharm, M.Pharm

Experience:

0 YEARS / Freshers

Salary:

₹300,000 to ₹600,000 per year.

Location:

Bangalore

As a Clinical Data Management Intern, you will manage clinical trial data for our pharmaceutical, biotechnology, and medical device company. Your role involves overseeing data collection, validation, and processing to ensure high-quality and compliant data management practices.

Objectives:

  • Oversee the collection, validation, and processing of clinical trial data.
  • Develop and implement data management procedures for clinical trials.
  • Support and facilitate 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 testing, and validation check testing and approval.
  • 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.Pharma or M.Pharma 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.

Application Link