Senior Clinical Data Associate

The role

The Senior Clinical Data Associate provides data management support throughout the clinical trial process from study start up to post database lock. This role involves database development, testing, and various data management activities under direct supervision.

What you will do

• Support the Lead DM as a back-up and/or team member
• Perform data entry for paper-CRF studies
• Perform quality control of data entry
• Assist in developing CRF specifications from the clinical study protocol
• Conduct database build UAT and maintain documentation
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review
• Run patient and study level status and metric reporting
• Perform medical coding of medical terms
• Assist with coordinating SAE/AE reconciliation

Required qualifications

• 5+ years’ experience
• Bachelor's and/or a combination of related experience
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
• Able to handle a variety of clinical research tasks
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral
• Basic knowledge of drug, device and/or biologic development and effective data management practices
• Strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance

Nice to have

• Experience in a clinical, scientific or healthcare discipline
• Dictionary medical coding (MedDRA and WHODrug)
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
• Oncology and/or Orphan Drug therapeutic experience

Before you apply

• Candidates must be legally authorized to work in the country of employment without employer sponsorship

About the company

Precision Medicine Group is an Equal Opportunity Employer.