What are the responsibilities and job description for the Senior Data Manager position at EMMES Corporation?
OverviewSenior Data ManagerUS RemoteEmmes Group : Building a better future for us all.Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry-leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people-driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!Primary PurposeThe Senior Data Manager is responsible for data management oversight activities for research studies. The Senior Data Manager works as an integral part of a cross-functional team through the lifecycle of the research study from design through final analysis and study closeout. The Senior Data Manager is responsible for the completeness and accuracy of the study data in the electronic database and serves as the primary point of contact with internal and external project teams on all aspects of data collection.ResponsibilitiesCollaborates with cross-functional teams and facilitates the design, documentation, testing, and implementation of clinical data collection studies in an electronic data capture (EDC) systemCreates and / or reviews study-specific electronic or paper Case Report Forms (CRFs) using prior knowledge, protocol-specific information, and departmental standards; works efficiently to incorporate core clinical team input and produce CRFs in a timely mannerDetermines data collection requirements based on the study protocol and system knowledge; makes recommendations based on previous experienceProactively identifies potential data management issues / risks and recommends / implements solutionsManages data collection and data validation at participating clinical sitesManages training documentation and provides oversight of system user access; may serve as a resource for troubleshooting system issuesCreates and / or reviews study data management documents according to instructions (e.g. Data Management Handbook, Data Management Plan, Data Validation Plan, EDC System User’s Guide, EDC Training and Certification Documents)Independently monitors own activities and project status for successful project deliverables according to timelinesManages data reports and creates data summaries or presentations as applicableManages the development of the data validation plan and ensures associated edit checks are completed in accordance with project timelinesManages and reconciles data obtained through Electronic Medical Records (EMR) integration, commercially available EDC systems, or other external data sourcesPerforms data review and query identification / resolution; manages data quality metrics for a protocol or project; may conduct or review data quality auditsAttends and contributes to project and department meetings; may serve as DM representative on external calls as requiredMentors staff on project-specific clinical data management processes; provides data management expertise at a project levelMay provide direct line support for DM staff. For direct reports : Collaboratively conducts performance and compensation review activities with the applicable project leader or designeeResponsible for addressing employee relations issues and resolving problemsEnsures DM salary and bonus equity complianceApproves timesheets, expense reports, and leave requestsOther duties as assignedQualificationsBachelor’s degree, preferably in a public health, clinical, science, technical, or related discipline; equivalent combination of education and relevant work experience may be considered in lieu of a degreeIncumbent typically will possess at least 6 years of progressive data management experience (or Master’s degree and 4 years) and good understanding of clinical research and / or data management processesNIDA experience requiredKnowledge of GCP and applicable regulatory guidelinesExperience in pharmaceutical industry and / or contract research organization preferredExperience in clinical electronic data capture (EDC) systems preferredKnowledge of Microsoft Office suite is essentialProven data management skillsExcellent verbal and written communication skillsSelf-motivated and proactiveStrong attention to detail, adaptable, and flexibleReliable and collaborative team memberWhy work at Emmes?At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including : Flexible Approved Time OffTuition Reimbursement401k Retirement PlanWork From Home Anywhere in the USMaternal / Paternal LeaveCasual Dress Code & Work EnvironmentCONNECT WITH US!Follow us on Twitter - @EmmesCROFind us on LinkedIn - EmmesThe Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.#LI-Remote#J-18808-Ljbffr
