Clinical Data Analyst

About the role

Join our team in Bridgewater, NJ. We are looking for a dedicated professional to perform activities for assigned studies in support of DM study lead in compliance with company processes, Good Clinical Practice (GCP), and regulations. This role is pivotal in ensuring the integrity and quality of clinical data.

Responsibilities

• Facilitate updating Data Management Documents such as Data Management Plan (DMP), Data Validation Plan, Data Review Plan, and CRF Completion Guidelines per Lead DM expectations.
• Verify external vendor test data per specifications document.
• Run and review outputs and database study metrics.
• Participate in data reviews.
• Review discrepancies in the Electronic Data Capture (EDC) system, monitor/facilitate resolution, and close out or re-query per study guidelines.
• Note and communicate trends to clinical trial manager(s) for follow-up.
• Reconcile external data to the clinical study database and perform Serious Adverse Event reconciliation.
• Ensure Data Management procedures and processes are adhered to in a consistent manner.
• Provide high-quality services through efficient and compliant processes.

Skills

• Hands-on experience with Electronic Data Capture systems (Medidata Rave desired).
• Excellent communication skills (verbal and written).
• Experienced working in a cross-functional team environment.
• Strong organizational skills.

Education

Minimally 2 years of clinical data management experience in a biotech, pharmaceutical, or CRO environment is preferred. Associates Degree or higher is required.