Clinical Data Associate II

are completed on time, with quality, and in accordance with corporate and regulatory requirements. The CDA II has a working knowledge of FDA regulations and general industry standards.

• With minimal oversight, develop Data Management (DM) documents including, but not limited to, Data Management Plans (DMPs), Case Report Forms (CRFs), Case Report Form Completion Guidelines (CRF CGs), Edit Checks, User Acceptance Testing (UAT) specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans. Utilize templates and standard guidelines to iniate documents, but exercise critical thinking and discretion to tailor documents to study needs
• With minimal oversight, lead data cleaning activities such as, but not limited to, study team data reviews, Non-system Edit Check Output review, Serious Adverse Event (SAE) reconciliation and non-CRF data recnciliation. Gather cross-functional input to create custom data review plans. Evaluate options and exercise discretion to choose efficient and effective issues resolution paths
• Demonstrate collaboration and relationship-building with all study team representatives (e.g. Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Project Managers, Clinical Trial Managers, Clinical Research Associates (CRAs), Clinical Pharmacologists, Biomarker/Bioinformatics scintists, Medical Writers, Regulatory representatives, etc.)
• Run SAS programs, review SAS logs, and generate output. Research and resolve even complex data discrepancies. May program SAS Non System Edit Checks (NSECs) and/or SAS Data Listings as appropriate for SAS skill level
• With minimal oversight, manage data deliverables processes, including database locks
• DM Project Management: With oversight, ensure data management deliverables are met on time. Utilize communication, available metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all data management activities. Ensure study team members from different functional areas understand and deliver components affecting data to ensure successful execution of deliverables. Provide solutions for data management issues that arise during study conduct
• Demonstrate "everyday leader" qualities
• Complete training assigned by Client and/or PXL, as necessary, including general training requirements, SOPs, and system and process related training
• Adhere to PXL and Client SOPs and processes