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Clinical Data Management Expert

1 month ago

Chennai, Tamil Nadu, India Saama Full time

Job Description:

Saama is seeking a highly skilled Business Analyst with a strong background in clinical data management to drive the development and optimization of clinical trials and research projects. This role is ideal for someone who is passionate about leveraging their expertise in clinical data management to drive business growth and improve operational efficiency.

Key Responsibilities:

  • Collaborate with cross-functional teams to understand business needs and identify opportunities for data-driven decision-making and process improvement.
  • Utilize data management expertise in data cleaning, discrepancy management, data quality checks, clean patient tracker, and missing pages to ensure the integrity and accuracy of clinical trial data.
  • Facilitate the development of user stories, product backlogs, and project plans to support the execution of clinical trials and research projects.
  • Perform competitive analysis to identify industry trends, benchmarks, and opportunities for innovation in clinical data management.
  • Engage with stakeholders to execute sprints, groom stories with engineering, and provide project updates through reports, presentations, and meetings.
  • Contribute to the ongoing development and refinement of data management strategies, tools, and practices to enhance operational efficiency and data quality.

Required Skills and Qualifications:

  • Bachelor's or Master's degree in a relevant field such as Biostatistics, Information Technology, Health Informatics, or related areas.
  • At least 5 years of experience in a business analysis role with a focus on clinical data management within the pharmaceutical, biotechnology, or healthcare industry.
  • Deep understanding of clinical trial processes, data management principles, and regulatory compliance requirements.
  • Proficient in the use of data management software and tools, with a strong emphasis on EDC systems, Data Management Workbench type systems, SQL.
  • Demonstrated ability to perform data analysis and present findings in a clear and concise manner.
  • Excellent problem-solving, organizational, and time management skills.
  • Strong communication and interpersonal skills, with the ability to work effectively in a team environment and interact with all levels of management and staff.

Preferred Skills and Qualifications:

  • Certification in clinical data management or related fields.
  • Experience with CRF design, MS Project, and analytical tools.
  • Knowledge of CDISC standards and data interchange formats (., SDTM, ADaM).
  • Familiarity with data privacy and protection regulations (., GDPR).

This role offers a unique opportunity to transform the field of clinical data management by working on innovative products and solutions. If you are a motivated individual looking to make a significant impact in the clinical research industry, we encourage you to apply for this exciting position.