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.
