Data Manager (Permanent role)- HYBRID - Horsham, PANew
About the position ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Data Manager on a permanent basis at Horsham, PA. (Hybrid 3 days from our office) Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career! The Data Manager is responsible for managing clinical data throughout the study lifecycle, including the development and maintenance of data management plans, validation plans, and specifications. The position ensures high-quality data delivery through the EDC system, performs user acceptance testing, data reconciliation, and database audits, and provides mentorship to junior team members. Responsibilities • 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