Clinical Data Associate

Summary

Join Precision for Medicine as a Clinical Data Associate/Senior Clinical Data Associate and provide comprehensive data management support throughout all phases of clinical trials. You will ensure adherence to SOPs, regulatory guidelines, and study-specific plans. Responsibilities include data cleaning, database testing, quality control, and team collaboration. The role requires 4+ years of data management experience, a Bachelor's degree in a scientific field, and proficiency in Microsoft Office. Preferred qualifications include experience in a clinical setting, medical coding knowledge, and understanding of CDISC standards. The position offers the opportunity to work on a variety of data management tasks and contribute to a dynamic team environment.

Requirements

• 4+ years’ experience within Data Management
• Bachelors within scientific/science background and combination of related experience
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
• Able to handle a variety of data management task and oversight
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral
• Basic knowledge of drug, device and/or biologic development and effective data management practices

Responsibilities

• Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner
• Perform data entry for paper-CRF studies, as needed
• Perform quality control of data entry
• Provide input into timelines. Ensure that clinical data management deadlines are met with quality. May assess resource needs for assigned projects, as needed
• Assist in developing CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
• Assist in building clinical databases
• Conduct database build UAT and maintain quality controlled database build documentation. May oversee overall quality of the clinical database
• Assist in specifying requirements for all edit check types e.g., electronic, manual data review, edit checks, etc
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Run patient and study level status and metric reporting
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Assist with coordinating SAE/AE reconciliation
• Assist with liaising with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables
• Assist with SAS programming and quality control of SAS programs used in the Data Management department
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• Assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
• Assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• Trains and ensures that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• Present software demonstrations/trainings, department/company training sessions, present at project meetings
• Perform other duties as assigned

Preferred Qualifications

• Experience in a clinical, scientific or healthcare discipline
• Dictionary medical coding (MedDRA and WHODrug)
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.)
• Oncology and Orphan Drug therapeutic experience