Job Description

: TemplateWe seek an experienced clinical data manager to join our team atThe primary responsibilities of the role will entail managing the clinical trial data of our pharmaceutical, biotechnology and medical device company.The ideal candidate should have extensive knowledge of the clinical data management principles, regulatory guidelines and industry best practices. They should be willing to work independently and collaboratively with cross-functional teams to ensure timely and accurate data delivery.We offer competitive compensation packages, comprehensive benefits and opportunities for growth and advancement within the company. If you are passionate about the medical field, we encourage you to apply!Objectives of this role

• Overseeing the collection, validation and processing of clinical trial data.
• Developing and implementing data management procedures for clinical trials.
• Supporting and facilitating the review of medical coding for validity and completeness.
• Ensuring compliance with applicable regulations, protocols and standard operating procedures in India.
• Maintain the highest data quality standards throughout the data lifecycle, from data collection to database lock.
• Stay updated on industry best practices, technological advancements and regulatory requirements related to clinical data management.

• Develop and maintain data management documentation, including study protocols, case report forms and data management plans.
• Design case report forms (CRFs) and electronic data capture (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 to ensure accuracy and completeness.
• Develop and execute standard operating procedures (SOPs) for approval, data entry screen design and testing, 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 issues about data management.
• Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations.
• Contribute to the development and validation of data management software tools.

• 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 electronic data capture (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 organisational and time management abilities.

• 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.

Talent Job Seeker