CDA (Data Management) -REMOTE

Orbis Clinical is seeking a CDA (Data Management) for 12 months.

Job Title: CDA (Data Management)

Location: REMOTE (client on EST time)

Contract: 12 months

Duties:

The CDA performs 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 (Essential Role 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

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

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $54.85 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). 

EEO and Reasonable Accommodation Statement:

Stone Harbor Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

 By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.