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Employment Type:
Full time
Job Category:
Health Care & Medicine
Senior Clinical Research Data Manager
(This job is no longer available)
Grad Date

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Job Description



Minimum Education
Bachelor's Degree

Specific Requirements and Preferences

Bachelor's degree in Epidemiology or Biostatistics. Master's Degree in Epidemiology or Biostatistics is preferred.

Minimum Work Experience
3 Year(s)

Specific Requirements and Preferences
At least 3 years plus, demonstrated of data management in FDA regulated clinical studies in human subjects preferred. Demonstrated 5+ yrs experience of data management in FDA regulated clinical studies in human subjects, preferred.

Functional Accountabilities

Database Management

  • Work directly with the client on the creation of clinical study databases.
  • Prepare Clinical Data Management Plans for complex studies
  • Oversee the development and implantation of data validation with checks and query programs.
  • Prepare, update and review clinical data management documentation.
  • Oversee project specific clinical database design, creation and testing.
  • Oversee the testing of clinical data management system edit/validation checks and discrepancy management activities being done by the Clinical Data Manager or Clinical Data Coordinators
  • Provide support and act as the Senior Clinical Data management point person to the Sponsor, CROs, vendors, clinical sites, and scorers
  • Develop presentations and present at Investigator meetings
  • Train, track, and manage users (Sponsors, Sites, Investigators and other study personnel) on the CDMS
  • Manage delivery of projects through full clinical data management process life-cycle,
  • Create, track, and manage clinical data management timelines, proposals, and budgets.

Standard Operating Procedures

  • Write SOPs, database templates and forms.
  • Train staff to implement clinical data management SOPs and policies.
  • Creation, completion, organization, and tracking of all data management documentation
  • Develop, edit, and review Standard Operating Procedures and Work Instructions as needed
  • Follow and ensure compliance with current Good Clinical Practices (cGCPs)

Clinical Data Analysis and Reporting

  • Expertise in biostatistics and epidemiology to enable the person to choose appropriate methods to address research questions.
  • Implement chosen methods to ensure underlying assumptions are met.
  • Prepare tables, graphs, results, written interpretation and descriptions for incorporation into publications, under the direction of a PhD statistician.

About Children's National Health System

Childrens National Medical Center is the only exclusive provider of pediatric care in the metropolitan Washington area and is the only freestanding childrens hospital between Philadelphia, Pittsburgh, Norfolk, and Atlanta. Serving the nations children for more than 130 years, Childrens National is a proven leader in the development and application of innovative new treatments for childhood illness and injury.

Childrens National is proudly ranked consistently among the best pediatric hospitals in America by US News & World Report.

Our Culture

Children's mission is to be preeminent in providing pediatric health care services that enhance the health and well-being of children regionally, nationally and internationally. Through leadership and innovation, Children's creates solutions to pediatric healthcare problems. Children's excels in Care, Advocacy, Research, and Education to meet the unique needs of children, adolescents and their families. Children's leadership realizes that our employees are the heart of our medical center and the soul of our mission. One of our greatest assets is the diversity of our workforce, which adds to the richness of our culture. Teamwork, dedication, and professionalism are essential values and characteristics that make our employees unique.

Childrens internationally recognized team of pediatric healthcare professionals care for more than 360,000 patients each year who come from throughout the region, nation and world. Our employees share a sense of pride and commitment to the patients and families we serve. We aspire to provide patients and their families with the highest quality of care and service in a family-centered environment. In essence, we are a team of "Great People Providing Great Care."

Nursing Students

As a nursing student, you might already be craving hands-on experience at a highly respected hospital. You may be thinking about where or with which population you want to work after graduation.

At Childrens, a world-class teaching hospital and internationally-recognized leader in pediatric health, we invite nursing students at all stages of learning to explore the real world of working in a hospital setting and experience first-hand the challenges and rewards of this career.

Internship Program

The internship program provides the novice nurse with the knowledge base and skill set needed to transition to competence in clinical nursing practice. While providing the needed skills to meet the organization goals and mission, the program provides nurses with the leadership skills to work collaboratively within a multidisciplinary team. The program bridges the gap between undergraduate education and real-life professional nursing practice, delivering state-of-the art pediatric care.

The program is offered to new graduate nurses from an accredited nursing program with a passion for children. All new graduates, with less than one-year acute care experience, are eligible to participate in the program after obtaining licensure.