Clinical Research Data Senior Specialist
Khalifa University · Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates
Apply & track with Apply EdgeKhalifa University’s research relates to key focus sectors of relevance to the UAE’s strategic economic growth and the technology platforms that serve as foundations for these sectors. The University’s research priorities are addressed in two categories — “verticals” and “horizontals” — which jointly cover specific industry and sector needs, technical platforms and expertise.The College of Medicine and Health Sciences and Khalifa University consist of 4 departments. These departments represent a commitment to excellence in education, research, and innovation across a spectrum of disciplines—from the advancement of biological sciences to groundbreaking innovations at the intersection of bioengineering and biotechnology, dedicated efforts in epidemiology and public health, and specialized education in medical science.Aligned with our vision for the future of healthcare and medicine, these focused departments will not only pave the way for groundbreaking advancements but will also introduce advanced degree programs.Position Overview:We are seeking an experienced, proactive Clinical Research Data Senior Specialist to join the College of Medicine and Health Sciences at Khalifa University. You will act as the primary data management point of contact for assigned studies, overseeing end-to-end clinical research data management activities from study start-up through to database-lock. This includes quality control, quality assurance and the development of QC reports.This role will act as the central point of contact for all data-related functions, with primary responsibility for the design, implementation, and oversight of electronic data capture systems, particularly REDCap. This includes database development, eCRF design, user access governance, validation processes, and technical support.You will be responsible for creating standard operating procedures, data collection forms, designing of electronic databases and training teams on data collection, QC resolutions and so forth. You will work closely with internal teams, faculty and collaborators to ensure high-quality data delivery, regulatory compliance and efficient study execution. You will also contribute to capacity building through REDCap training and mentorship.Position Requirements:Serve as the primary data management lead for assigned clinical research studies, including sponsor- facing responsibilities and ownership of data management deliverablesLead and co-ordinate the design, development, testing and deployment of EDC systems, ensuring timelines and quality standards are met.Develop and design eCRFS and edit checks, validation rules, branching logic and contribute to rapid CRF generation post protocol finalization.Lead the design, development, testing, implementation, and administration of EDC systems, with a focus on REDCap.Serve as subject matter expert in REDCap programming and system configuration.Manage REDCap users, roles, and permissions in compliance with data security and governance requirements.Develop and deliver REDCap training programs.Provide ongoing technical support to research teams.Mentor junior staff and promote best practices in data management.Draft and maintain data management plans, CRF completion guidelines, edit check specifications and data review plans and SOP development.Establish, track and manage external data streams (e.g. central labs, imaging etc) including data transfer agreements.Perform regular data reviews, ongoing data cleaning, review, and quality checks, discrepancy management and issue resolution in collaboration with internal teamsLead database lock and archival activities, ensuring documents are monitored and inspection ready.Monitor and ensure timely data collection, coding and cleaning in accordance to study timelines.Support GCP inspections and external audits, representing the data management function as neededLead database lock and archival processes.Ensure all data documentation is audit ready.Support internal and external audits and GCP inspections.Ensure compliance with relevant ICH-GCP, 21 CFR Part 11, other regulatory and sponsor specific standards.Complete any other tasks assigned by line managerCandidate Profile:Essential CriteriaMasters from a reputable university in a life science, health science, computer science or related disciplineMinimum of 4 years of experience in clinical research data managementExperience as a lead data manager on several full-service studiesExperience with electronic data collection systemsExperience with merging data from different sources and programsExperience of undertaking assigned data tasks and starting to manage own workloadA willingness to contribute to a collaborative and supportive team cultureExcellent English language communication skills (verbal and written)Ability to function as part of a team working on multiple tasks with competing demands and deadlinesWell-developed reasoning and problem-solving skillsDesired CriteriaPhD from a reputable university in a life science, health science, computer science or related discipline