Data Manager (Permanent role)- HYBRID - Horsham, PANew
About the positionResponsibilities• Participate in the review of Clinical research documents (e.g., Protocols, Case Report Forms (CRF), and reports). • Develop Data Management Plan (DMP), maintain DMP throughout lifecycle of study project, and ensure DMP is followed according to study design and requirements. • Create and maintain Data Validation Plan and Data Review Plan. • Create Data Entry Guidelines. • Create eCRF Completion Guidelines. • Create Data Transfer Specifications. • Develop and review electronic Case Report Form (eCRF) and/or paper CRF.• Develop database (DB) clinical trial data specifications, including eCRF design, edit rules/checks, and query logic and data validations. • Perform external data reconciliation in collaboration with programmers. • Develop User Acceptance Testing (UAT) Plan and create and maintain all UAT documents, including but not limited to edit check document, issue logs, and UAT checklists. • Perform UAT of data entry screens and edit checks. • Perform site/clinical research associate (CRA) training and create user guides.• Deliver high quality clinical data within the Electronic Database Capture (EDC) system to ensure successful freeze/lock as appropriate for statistical review, interim review, and or final database lock. • Perform unfreeze/unlock procedures if required. • Coordinate the archiving of study databases and related documents. • Perform database audits for paper studies. • Perform SAE reconciliation. • Provide mentorship to junior members. • Work with project manager and cross-functional team members to maintain project timeline and overall quality of deliveries.Requirements• Bachelor's degree in clinical/pharmacy/biological/mathematical sciences or related field or nursing degree. • At least 4 years data management and/or related work experience in a medical device or pharmaceutical industry/company is preferred. • Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology. • Working knowledge of Clinical database applications such as EDC. Apply tot his job