Clinical Data Manager II

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes. RESPONSIBILITIESComplete all Data Management tasks from study start-up to database lock for assigned studies according to the applicable SOPs and study-specific procedures. Lead small to medium size studies. Effectively interact with sponsors and manage vendors. Provide input to departmental SOPs and design study-specific procedures: Develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, add Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock ProceduresWork with DB programmers to design (e)CRFs and edit checks in EDC system for small to medium complexity studiesDevelop test scripts and test data for User Acceptance Testing (UAT)Coordinate eCRF screen and edit check UAT tasks for small to medium complexity studiesPerform and document UAT, including database testing, data export testing, and testing of custom programmingReceive, integrate, and reconcile electronic dataDesign study-specific processes for electronic data receipt and handlingPerform and coordinate data review via listings and EDC systemManage query issue and resolution to ensure data completeness and integrityReview medical coding listings and provide inputAssist with data listing design for data reviewPerform SAE reconciliationPerform pre-lock and data lock tasksPrepare training materials and user guides for EDC data collection toolsParticipate in client and team meetings and provide inputDesign, generate, and review status metric reports, as neededPerform archiving of study databases and related documentsOrganize and file study documentationProvide input to cross-functional study timelines and resource requirements to ensure timely completion of project milestones • Provide regular status updates, keeping cross-functional study team, management, and sponsors informed of any changesProvide study specific training for team membersImplement technical solutions and resolve issuesLead small to medium complexity projectsDelegate tasks as appropriateInteract with sponsors and manage vendorsAssist with identification of project scope changesAssist with sales and marketing presentationsParticipate in departmental process improvements EDUCATIONMinimum BS in a scientific or health related field or equivalent EXPERIENCEMinimum 3 years of experience in Clinical Data Management SKILLSKnowledge of medical terminology and pharmaceutical notationExpertise with EDC systems, such as Medidata Rave, InForm, MedrioExcellent communication and time management skillsLeadership skills PHYSICAL REQUIREMENTSIncumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time. The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate’s work experience, education/training background and parity with current employees in the same or similar positions.