Clinical Research Data Manager

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 3 years of data management experience in clinical studies with human subjects (1 yr with MS) (Required)

Required Skills/Knowledge
Knowledge of REDCap, OpenClinica, SAS or other database systems.
Demonstrated excellent written, verbal, inter-personal and communication skills.
Good multi-tasking and organizational skills.

Functional Accountabilities
Database Management

• Work with principal investigators and study coordinators to create the optimum database for clinical trials or observational studies.

• Create case report forms, clinical study databases, and standard data structures.

• Prepare data management plans; validate data with checks and query programs.

• Prepare, update and review data management documentation.

• Review analytical tables and listings and study reports.

• Create and conduct data quality control activities at defined time points.

Standard Operating Procedures

• Help all PIs and study coordinators with the creation of SOPs, database templates and forms.

Data Analysis

• Perform clinical data analysis to support outcome measures of clinical protocols.
• Anticipate and responds to customer needs; follows up until needs are met

Teamwork/Communication

• Demonstrate collaborative and respectful behavior

• Partner with all team members to achieve goals

• Receptive to others’ ideas and opinions

Performance Improvement/Problem-solving

• Contribute to a positive work environment

• Demonstrate flexibility and willingness to change

• Identify opportunities to improve clinical and administrative processes

• Make appropriate decisions, using sound judgment

Cost Management/Financial Responsibility

• Use resources efficiently

• Search for less costly ways of doing things

Safety

• Speak up when team members appear to exhibit unsafe behavior or performance

• Continuously validate and verify information needed for decision making or documentation

• Stop in the face of uncertainty and takes time to resolve the situation

• Demonstrate accurate, clear and timely verbal and written communication

• Actively promote safety for patients, families, visitors and co-workers

• Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance