Senior Clinical Research Data Manager

Location
Washington, District of Columbia-Washington
Posted
Aug 19, 2020
Closes
Sep 23, 2020
Ref
200001D7
Industry
Healthcare
Hours
Full Time
The Sr Clinical Data Manager will help oversee the clinical database and clinical data management aspects of the Biostatistical and Study Methodology Division and provide support for the implementation of project specific database design, creation and testing. Train staff on implementation of clinical data management SOPs and policies. Choose and implement appropriate methods to address clinical research questions by preparing tables, graphs, and results and written interpretation. Work closely with all Coordinating Center staff and study team leadership to accomplish these goals.

Qualifications

Minimum Education
Bachelor's Degree - Applicable degree such as Epidemiology, Biostatistics, Information Systems or a related field. (Required)

Master's Degree - Applicable degree such as Epidemiology, Biostatistics, Information Systems or a related field (Preferred)

Minimum Work Experience
3 years - Demonstrated of data management in FDA regulated clinical studies in human subjects. (Required)

5 years - Demonstrated of data management in FDA regulated clinical studies in human subjects. (Preferred)

Required Skills/Knowledge
Knowledge of REDCap, OpenClinica, SAS or other database systems
Demonstrated excellent written, verbal, interpersonal and communication skills
Good multi-tasking and organizational skills.
Understanding of statistical reporting and basic analysis functions

Functional Accountabilities

Database Management
1. Work directly with the client on the creation of clinical study databases.
2. Prepare Clinical Data Management Plans for complex studies
3. Oversee the development and implantation of data validation with checks and query programs.
4. Prepare, update and review clinical data management documentation.
5. Oversee project specific clinical database design, creation and testing.
6. 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
7. Provide support and act as the Senior Clinical Data management point person to the Sponsor, CROs, vendors, clinical sites, and scorers
8. Develop presentations and present at Investigator meetings
9. Train, track, and manage users (Sponsors, Sites, Investigators and other study personnel) on the CDMS
10. Manage delivery of projects through full clinical data management process life-cycle,
11. Create, track, and manage clinical data management timelines, proposals, and budgets.

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

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

Organizational Accountabilities
Organizational Accountabilities (Staff)


Organizational Commitment/Identification

1. Anticipate and responds to customer needs; follows up until needs are met

Teamwork/Communication

1. Demonstrate collaborative and respectful behavior
2. Partner with all team members to achieve goals
3. Receptive to others' ideas and opinions

Performance Improvement/Problem-solving

1. Contribute to a positive work environment
2. Demonstrate flexibility and willingness to change
3. Identify opportunities to improve clinical and administrative processes
4. Make appropriate decisions, using sound judgment

Cost Management/Financial Responsibility

1. Use resources efficiently
2. Search for less costly ways of doing things

Safety

1. Speak up when team members appear to exhibit unsafe behavior or performance
2. Continuously validate and verify information needed for decision making or documentation
3. Stop in the face of uncertainty and takes time to resolve the situation
4. Demonstrate accurate, clear and timely verbal and written communication
5. Actively promote safety for patients, families, visitors and co-workers
6. Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance

Children's National Health System is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender, identity, or other characteristics protected by law.

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