Clinical Data Associate

Smart IMS Inc; Bridgewater Township (NJ); On-site; USD 48,000 - 76,000; Full time

Job summary

Smart IMS Inc is seeking a Clinical Data Associate in Bridgewater, NJ (onsite) for a 12-month contract. You will support DM study leads, edit DM documents, and perform data reviews and reconciliation in a compliant, timely manner.

Responsibilities include updating DM plans, performing UAT, and ensuring high-quality data management through cross-functional collaboration. A2+ years in CDM and Medidata Rave experience are desired.

Qualifications

• Minimally 2 years of clinical data management experience in biotech, pharma, or CRO environments.
• Hands-on experience with EDC systems, Medidata Rave preferred.
• Excellent written and verbal communication skills.
• Experience working in cross-functional teams.
• Strong organizational skills and attention to detail.

Responsibilities

• Edit and update DM documents and study plans under DM lead guidance.
• Conduct UAT testing, data review, and discrepancy management.
• Reconcile external data to the clinical study database and perform SAE reconciliation.
• Track issues, generate data listings, and file DM documents in trial master files.
• Ensure DM procedures are followed consistently and provide high-quality services.

Skills

Clinical data management

Excellent communication

Cross-functional teamwork

Organizational skills

EDC experience

Education

Associate's degree or higher

Tools

Medidata Rave

Job description

Job Title: Clinical Data Associate
Duration (Contract): 12 Months
Client Location: Bridgewater, NJ 08807

Location Preference: Onsite

Job Description:

As a Clinical Data Associate, you will perform activities for assigned studies in support of DM study lead in compliance with company processes, GCP and regulations. Responsibilities may include editing and updating DM documents, conducting UAT testing, performing data review, discrepancy management, data reconciliation, data listing generation and distribution, tracking issues, performing database QC, and filing DM documents in the trial master file.

Responsibilities:

Facilitate updating DM Documents Data Management Plan (DMP), Data Validation Plan, Data Review Plan, 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 EDC system, monitor/facilitate resolution and closeout or re-query per study guidelines; note and communicate trends to clinical trial manager(s) for follow-up

Reconcile external data to clinical study database and perform Serious Adverse Event reconciliation

Ensure DM procedures and processes are adhered to in a consistent manner

Provide high-quality services through efficient and compliant processes

Required Skills, Experiences, Education and Competencies:

Minimally 2 years of clinical data management experience in a biotech, pharmaceutical, or CRO environment is preferred. Associate's degree or higher is required

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

The hourly range for roles of this nature are $35.00 to $55.00/hr. Rates are heavily dependent on skills, experience, location, and industry.

cyberThink is an Equal Opportunity Employer.