Database Analyst---Clinical Data Collection Strategies (Associate)

Role Summary

As a member of our Clinical Data and Information Sciences (CDIS) group, an integral delivery unit within our Clinical Development & Operations (CD&O) organization, you will work closely with department roles and cross-functional study team members to create data capture solutions that support the quality and timely delivery of data required per standard and study specific data review plans. Location: Hybrid.

Responsibilities

• Program high quality clinical databases
• Design, develop and maintain clinical databases, ensuring the integrity of clinical data and application of standards supporting consistency in asset/submission data
• Comply with applicable SOPs and work practices

Qualifications

• Required: Minimum of 1 year of relevant technical experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions
• Required: Experience with Oracle, PL/SQL, SAS, or Java
• Required: Relational database design and database programming skills
• Required: Strong communication skills—written and verbal
• Preferred: Java experience
• Preferred: Technical skills and experience using relational databases (e.g., Oracle InForm, Oracle DMW, MS SQL Server or MS Access)
• Preferred: Strong decision-making, influencing, and negotiation skills
• Preferred: Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g., data review, study reports, regulatory submissions, safety updates, etc.)
• Preferred: Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable

Education

• Bachelor's degree in a Life Science, Computer Science or other related discipline

Skills

• Analytical thinking and problem-solving
• Effective written and verbal communication
• Collaborative cross-functional teamwork