Clinical Data Standards Lead – SDTM & RAVE

Aequor; Basking Ridge (NJ); Hybrid; USD 100,000 - 130,000; Full time

Job summary

A leading clinical research organization located in Basking Ridge, NJ is looking for a Manager for Clinical Data Standards. The role involves developing and sustaining global clinical data standards crucial for quality submissions. This manager will work with diverse teams to optimize data collection and ensure compliance with industry standards. The position requires a minimum of 5 years of experience, a Bachelor's Degree in life sciences, and a strong understanding of the RAVE system and SDTM. A hybrid in-office presence is expected.

Qualifications

• 5+ years of experience in relevant roles, preferably in CRO or pharma.
• Strong expertise in clinical data standards and SDTM.
• Experience in data collection methods including EDC.

Responsibilities

• Manage development and sustainability of Global Clinical Data Standards.
• Collaborate with cross-functional stakeholders to optimize data collection.
• Ensure alignment with industry standards for health regulations.

Skills

CRO/pharma working background

Minimum 5 years of experience

RAVE system knowledge

SDTM knowledge and experience

Strong communication and presentation skills

Education

Bachelor's Degree or higher in life sciences or related field

Tools

RAVE

Job description

A leading clinical research organization located in Basking Ridge, NJ is looking for a Manager for Clinical Data Standards. The role involves developing and sustaining global clinical data standards crucial for quality submissions. This manager will work with diverse teams to optimize data collection and ensure compliance with industry standards. The position requires a minimum of 5 years of experience, a Bachelor's Degree in life sciences, and a strong understanding of the RAVE system and SDTM. A hybrid in-office presence is expected.