Hybrid Lead, Clinical Data Management

BioNJ Inc.; Warren Township (NJ); Hybrid; USD 164,000 - 206,000; Full time

Job summary

BioNJ Inc. is seeking an Associate Director, Clinical Data Management to lead data management activities ensuring accuracy of clinical databases for analysis and reporting.

You will shape plans for EDC and data applications, and supervise internal staff and vendors while collaborating with Clinical Operations, biostatistics, and SAS programmers. The role involves developing data management plans, overseeing data reconciliation and database lock, and ensuring regulatory compliance across SOPs

Qualifications

• Bachelor’s degree in science or related field and at least 8 years of relevant experience in pharma/biotech/CRO.

Responsibilities

• Provide leadership and oversight of data management activities to ensure accuracy and consistency of clinical databases.
• Develop and implement plans for EDC system processes and other data applications.
• Collaborate with CROs to ensure proper execution of data management plans.
• Design and develop data collection instruments (eCRFs) for statistical analysis.
• Oversee data cleaning, reconciliation, SAEs, and data lock activities.
• Lead development of data management and review plans and supervise database development.
• Prepare periodic study status reports and communicate with cross-functional teams.

Skills

Leadership

Data management

SAS

EDC (Electronic Data Capture)

IWRS

Regulatory knowledge

Communication

Project management

Problem solving

Education

Bachelor’s degree in science or related field

Tools

Medidata RAVE

Oracle RDC

InForm

Veeva EDC

SAS

Job description

BioNJ Inc. is seeking an Associate Director, Clinical Data Management to lead data management activities ensuring accuracy of clinical databases for analysis and reporting.

You will shape plans for EDC and data applications, and supervise internal staff and vendors while collaborating with Clinical Operations, biostatistics, and SAS programmers. The role involves developing data management plans, overseeing data reconciliation and database lock, and ensuring regulatory compliance across SOPs