Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Data Manager to join our vibrant team at Rockville, MD.
- Coordinate development of a core data management resource.
- Develop data management training and support resources.
- Establish and oversee quality management processes.
- Train site staff in data entry.
- Create and manage data management workflows and project timelines to track progress of data management activities.
- Oversee and participate in coordination of core clinical trial data tasks including: Case Report Form (CRF) development, processing intake of CRFs, data entry of CRFs into Clinical Data Management System (CDMS), development of edit checks and generation and resolution of data queries, and interim data reports.
- Establish strong communication pathways with the data operation team, project managers, statistical support and other internal and external stake holders.
- Serve as the escalation point-of-contact for unresolved data issues.
- Consult about data management facilities and staffing for special projects.
Experience Required / Requirements
- Bachelor’s Degree in health and/or healthcare informatics, clinical, biological or mathematical sciences or related field or equivalent experience.
- Minimum of eight (8) years direct data management experience with at least three (3) years as a clinical data management project lead.
- Previous experience managing the delivery of multiple projects through the full data management life cycle.
- Thorough knowledge of the data management process (e.g., serious adverse event reconciliation, management of local laboratory data) and knowledge of data management operating procedures.
- Knowledge of clinical research regulations including Good Clinical Practices and relevant regulatory guidelines.
- Working knowledge of clinical research operations, clinical trials, medical terminology, and/or pharmacology.
- PMP certification and/or familiarity with REDCap, SAS and R is a plus.
- Travel will be required, as much as 75% of the time across the United States and US Territories; length of travel: two weeks up to perhaps a month; depending on the need at the clinical site.
- Travel domestically among the 60 clinical sites in one year.
- Paid Time Off (PTO)
- 10 Paid Federal holidays
- Generous health coverage provided with no monthly premium to the employee
- Generous vision and dental coverage provided with no monthly premium to the employee
- Short and Long-Term Disability coverage (paid by company)
- Basic Life and AD&D coverage (paid by company; option to purchase additional coverage)
- 401(K) with significant company match & no vesting period
- Competitive salaries with performance bonus opportunities
- Discount plan for pet care, legal services, & identify theft protection
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact:
Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.