Overview Data Manager US Remote Emmes 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 Data Manager is responsible for data management activities for research studies. The 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 Data Manager is responsible for the completeness and accuracy of the study data in the electronic database and collaborates with internal and external project teams on all aspects of data collection. Responsibilities
- Participates with cross-functional teams in design, documentation, testing, and implementation of clinical data collection studies in an electronic data capture (EDC) system
- Designs and/or develops study-specific electronic or paper Case Report Forms (CRFs), ensuring consistency with study protocol, clinical requirements, and accurate and efficient data collection
- Collaborates with the project team and other study personnel to determine data collection requirements based on the study protocol and system knowledge
- Documents and resolves data management issues for a protocol or group of protocols
- Assists with communication for internal and external teams to resolve data management issues
- Creates or reviews data validation check specifications; coordinates with relevant parties in the development and testing of eCRF and data validation checks
- Helps organize project team meetings and facilitates efficient project communication to ensure deadlines are met; participates in department meetings
- Creates and maintains 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)
- Prepares data reports and assists with data presentations as applicable
- Reviews data obtained through Electronic Medical Records (EMR) integration, commercially available EDC systems, or other external data sources
- Mentors assigned employees on data management procedures and guidelines
- Identifies and resolves data queries and discrepancies; contributes to data quality metrics for a protocol or project; conducts data quality audits
- Conducts training for users on the EDC system and protocol-specific EDC requirements; maintains training documentation and manages system user access
- Other duties as assigned Qualifications
- Bachelor'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 degree
- Incumbent typically will possess at least 2 years of data management experience (or Master's degree) and basic understanding of the clinical development and data management processes
- Experience in clinical electronic data capture (EDC) systems preferred
- Knowledge of Microsoft Office suite is essential
- Ability to handle multiple tasks at one time and to work with minimal supervision
- Excellent verbal and written communication skills
- Strong attention to detail, adaptable, and flexible Why 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 Off Tuition Reimbursement 401k Retirement PlanWork From Home Anywhere in the US Maternal/Paternal Leave Casual Dress Code & Work Environment CONNECT WITH US!Follow us on Twitter - @EmmesCROFind us on LinkedIn - Emmes The 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