Lead Data ManagerUS Remote Worker
The Emmes Company, LLC (“Emmes”) is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.
Our “Character Achieves Results” culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.
If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients’ success by sharing ideas openly and honestly.
Primary PurposeThe Lead Data Manager provides data management (DM) oversight for one or more research studies, manages the data team through the lifecycle of the research study from design through final analysis and study closeout, is responsible for ensuring high-quality data management deliverables and adherence to timelines and budget on a research study, and serves as the lead representative for the DM team to customers. Also provides leadership and guidance to the DM team and ensures compliance with applicable regulations and guidelines.
- Customer Satisfaction Management
- Serves as lead representative of DM team to customer and maintains open communication
- Ensures high-quality DM deliverables and adherence to study timelines and budget according to statement of work
- Ensures audit readiness of DM documents
- Serves as primary escalation point for DM issues and follows through to resolution
- Project Satisfaction Management
- Interfaces with internal project team as the DM team representative and establishes open communication with other functional representatives
- Provides support and justification of DM resources, timelines, and processes
- Works with DM resource managers to ensure proper DM staffing on team
- Escalates issues to project leaders as per established project and corporate requirements
- Reviews and approves study DM documents
- Provides oversight for the DM study team through mentoring, training, and coordinating the work of DM team members
- Provides DM leadership and expertise to the study team
- Manages DM SOW/provide DM budget input for study
- Identifies out of scope DM work and supports change order process
- DM Department Support
- Provides feedback to DM department management on individual and DM team performance
- Provides support for DM department initiatives and objectives
- Serves as DM team representative in department meetings and shares best practices and lessons learned
- Models and reinforces the corporate culture through vision, action, and learning
- Direct Report Management
- Collaboratively conducts performance and compensation review activities with the applicable project leader or designee
- Responsible for addressing employee relations issues and resolving problems
- Ensures DM salary and bonus equity compliance
- Escalates performance issues to DM leadership
- Approves timesheets, expense reports, and leave requests
- Other duties as assigned
- 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 8 years progressive data management experience and strong understanding of clinical research and/or data management processes, including at least 3 years with DM lead or supervisory experience
- Knowledge of GCP and applicable regulatory guidelines
- Experience in pharmaceutical industry and/or contract research organization preferred
- Experience in clinical electronic data capture (EDC) systems preferred
- Excellent verbal, written, presentation, and interpersonal communication skills with an ability to inform, influence, and collaborate
- Strong project management, organizational, and analytical skills
- Ability to coordinate the work of others
- Demonstrated supervisory skills
- Strong attention to detail, adaptable, and flexible
- Knowledge of Microsoft Office suite is essential
- Prior experience with Medidata Rave is highly desired
Emmes is a federal government contractor and requires all employees to be fully vaccinated against COVID-19, to the extent permitted by applicable law. Individuals with medical conditions or sincerely religious beliefs or practices that prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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:
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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.