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.
RESPONSIBILITIES
Manage and supervise a team of Clinical Data Managers (CDMs)Oversee each project assigned to the teamQC each deliverable prior to sending to internal or external clientsPrepare and present individual performance reviewsProvide mentorship to DM staff and suggest/implement solutions for complex issuesAssist staff with interactions with sponsors and managing vendorsKeep supervisor updated on study progress and staff management through routine meetingsMaintain a positive, progressive, and proactive management style and communicationDevelop and update data management SOPs and training manualsConduct data management training as well as study specific training for the CDM and study teamsProvide input from the data management perspective regarding the design of clinical trial protocolsOversee, develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock ProceduresOversee and participate in the process of data review and query generation proceduresOversee and participate in the coding of medical termsOversee/define/perform SAE reconciliation processesWork with DM leads and DB programmers to design (e)CRFs and edit checks in EDC system Ensure proper completion of UAT of EDC system and modulesOversee DM lead to ensure efficiency and quality of electronic data receipt, integration, and reconciliationReview queries and trends to ensure data completeness and integrityReview/prepare training materials and user guides for EDC data collection tools, deliver user trainingParticipate in client and team meetings as required advising on best practices as appropriateProvide input to cross-functional study timelines and resource requirements to ensure timely completion of project milestones for complex studiesProvide regular status updates, keeping cross-functional study team, management, and sponsors informed of any changesImplement technical solutions, new tools, and process improvement strategiesLead large and complex projectsIdentification of project scope changesPresent at sales and marketing meetings for prospective clientsProvide strategic input to the department and company goalsLead key departmental goals and initiativeEDUCATION
Minimum BS in a scientific or health related field or equivalentEXPERIENCE
Minimum of 10 years of experience in Clinical Data ManagementMinimum 2 years supervisory experience is requiredSKILLS
Knowledge of GCPs and regulatory agency guidelinesFamiliarity with medical terminology is requiredSkilled in the use of data management software application, Medidata RAVEExcellent organizational and time management skillsStrong collaboration and leadership skillsExcellent oral and written communication skillsStrong interpersonal skillsPHYSICAL REQUIREMENTS
Incumbents 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.