Senior 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 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

• 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.
• 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