Principal Clinical Data Associate (19-00823) – WA

Position Summary:
The Principal CDA is a Management-level CDA capable of leading Data Management aspects of a clinical study with minimal support and oversight. The Principal CDA has thorough knowledge of FDA regulations and industry standards, strong technical skills, and is capable of leading infrastructure assessment and improvement. This position may manage vendor/CRO relationships. 

Principal Responsibilities:
• Independently lead all data management aspects of a clinical study, including on pivotal, blinded, and randomized trials 
• Independently develop DM documents including, but not limited to, Data Management Plans, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans. Demonstrate critical thinking, alignment-building and discretion to author documents that meet study needs 
• Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product. Assist in the selection of vendors/CROs (e.g. review RFPs, attend site audits) 
• Adeptly run SAS programs, review SAS logs, and generate output. Program SAS Non-System Edit Checks (NSECs) and/or SAS Data Listings as appropriate for SAS skill level. Mentor less proficient SAS users as appropriate 
• Independently lead data cleaing activites such as study team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliation. Coordinate cross-functional input to drive creation of custom data review plans. Evaluate multiple options, exercise discretion and utlize experience to choose efficient and effective issues resolution paths
• Understand critical tasks and milestones; ensure data management deliverables are met per study timelines. Utilize experience and appropriate tools to efficiently lead and coordinate data management activities. Ensure study team members understand and deliver components affecting data to ensure successful execution of deliverables. Assist DM Management in coordinating and/or supervising data management activities across studies 
• Research, evaluate and lead departmental initiatives and new technologies/innovations to improve CDM processes; represent CDM through working groups (internal and external) and initiatives where thorough knowledge of CDM practices/processes are required 
• Coordinate and delegate work performed by junior CDAs, as needed; assist in mentoring of junior CDAs and/or contractors; may manage CDAs 

• Years of experience: 8+ years 
• Requires effective organizational and communication skills 
• Thorough knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, medical coding, the drug development process 
• Previous relevant EDC experience 
• Previous vendor/CRO management 
Source: Job Diva – Job Listing

Leave a Reply

Your email address will not be published. Required fields are marked *