R&D Partners is seeking to hire a Remote Clinical Data Associate (East Coast).

Your main responsibilities as a Remote CDA:

• Perform Data Management (DM) activities for assigned studies in support of DM study lead
• Complete assigned tasks in compliance with company processes, GCP and regulations which 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
• Facilitate updating DM Documents (e.g., 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
• Contribute on DM documents (Data Management Plan, Data Validation Specifications/ Plan, Data Review Plan, CRF Completion Guidelines, Data Transfer Agreements, etc.)
• Perform database UAT testing
• Perform data reviews, query management and data reconciliation

Must Have Requirements:

• Associates Degree or higher is required
• Minimally 3 years of clinical data management experience in a biotech, pharmaceutical, or CRO environment
• Hands on experience with Medidata Rave EDC
• Must have excellent communication skills (verbal and written)
• Strong organizational skills
• Excellent collaboration skills and working in a cross- functional team environment
• Demonstrated ability to prioritize work
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook)

Pay Scale:

• $36-45 hour (Dependent on Experience)

Benefits:

• Competitive pay
• Full-Time role
• Benefits + 401k

R&D Partners is a specialist employment agency and recruitment business providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal opportunity employer.