Lexitas

Compensation

Full Description

Overview Provides operational data management project leadership and oversight to Clinical Data Leads (CDL’s) and Clinical Data Coordinators (CDC’s). Must be an expert in the technical responsibilities of the position. Manages the data management deliverables, ensuring that the quality of data is consistent with the sponsor and departmental expectations and aligns with the study protocol. Responsibilities Provide oversight of Clinical Data Leads and Clinical Data coordinators in the planning, implementation, and closeout of data management activities for clinical research projects. Ensure that project activities are produced according to the study scope, budget, and timelines. Oversight of external data management resources and vendors if any data management study activities are being performed by another service provider. Oversight and review of all database development activities including, but not limited to, eCRF development, Data Validation Specifications development, eCRF Completion Guidelines development, User Acceptance Testing, and Data Management Plan development. Work actively with the clinical and data management study teams to review study data and ensure data quality. Identify and escalate any risks to database integrity, study timelines, and resourcing to the appropriate individuals. Responsible for communicating with internal study teams, sponsor study teams, and study stakeholders on data management progress, timelines, issues, and risks. Participate in and lead client team meetings with respect to data management activities as needed. Ensure appropriate training to the study team on the use of electronic data capture technology Requirements Education: Required: a B.S./B.A. or advanced degree Experience: A minimum of 6+ years of clinical data management experience, preferably in a CRO setting. Experience leading multiple studies in a client facing role. Experience leading departmental initiatives preferred. Skills: Experience with two or more commercial Electronic Data Capture platforms preferred. Must have a good understanding of clinical research operations including GCP and regulatory requirements and operational procedures Experience in ophthalmology preferred Experience in a CRO setting is strongly preferred Must be highly customer service oriented and have creative initiative with a positive attitude Understands and shares the organizational values of developing and maintaining good relationships internally and externally. Quality of interactions reflects emphasis on relationships Able to work in a fast-paced environment and easily adapt to changing priorities Must have excellent management and communication skills (written and verbal), strong problem-solving skills, and be detail oriented Advanced skills in computer operation, spreadsheet creation/maintenance, word processing and electronic data captures systems are essential Physical Requirements Position requires: ordinary ambulatory skills and physical coordination sufficient to move about conference or meeting locations as required; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Disclaimer: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. Lexitas Pharma Services, Inc., at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Lexitas Pharma Services, Inc., at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.