Senior Clinical Data Manager

Group: Data Management

Reports to: Manager, Data Management

Responsibilities Include:

The Senior Clinical Data Manager is responsible for the performance of data
management tasks from study start-up through database lock for assigned clinical
research projects, including paper-based and electronic data capture (EDC) studies, and is
responsible for overall data quality and documentation on clinical research projects.
The Senior Clinical Data Manager will work on mid to large sized complex projects in
various indications and will lead a team of CDMs on the project to ensure all the
contracted activities are carried out according to the Standard Operating Procedures of
Verisat and/or Sponsor specific requirements. Specific responsibilities on these projects
include:
· Review and finalization of case report forms (CRFs)
· Development of CRF Completion Guidelines (CCGs)
· Development of Data Validation Specifications (DVS)
· Testing of the DVS programs and working with the Database Developer to
resolve all findings before releasing into production.
· Pre-entry preparation of forms for data entry
· Data Cleaning activities including data review and query generation and
integration
· Coding
· SAE Reconciliation
· Handling of external data (e.g., Central Labs, IVRS, etc.)
· Database Quality Control activities
· Database Lock
· Producing and providing metrics on data processing status to the Project Manager
and/or Sponsor as needed
· Work with the other functional groups (e.g., Biostatistics, Statistical
Programming, Clinical Monitoring, Medical Writing, Project Management, etc.)
to ensure data management aspects of the project are properly considered and
integrate well with the other activities.
· Liaises between study center personnel and the client, as appropriate, regarding
clinical and/or technical issues
The Senior Clinical Data Manager may serve as a technical lead in a specific area across
projects within the department (e.g., Coding Expert). As such a Senior Clinical Data
Manager may perform quality control activities on projects across the department
providing feedback to the necessary individuals and work with them to correct any issues.
The Senior Clinical Data Manager may serve in a Project Management capacity on
projects as deemed necessary and appropriate.
In consort with managers within Data Management, the Senior Clinical Data Manager
promotes consistent operations, efficient use of resources, and sharing of knowledge and
best practices.
The Senior Clinical Data Manager will in consultation with the managers develop and
deliver training to other data managers on project specific and general data management
processes, procedures and systems. The Senior Clinical Data Manager may also provide
data management training to other functions across Veristat, Inc.
The Senior Clinical Data Manager may assist in business development activities such as
capabilities presentations representing the data management department.
The Senior Clinical Data Manager promotes teamwork across functional groups.

Minimum Requirements

· A BA or BS degree in a health-related field or Registered Nursing degree, with a
minimum of 5 years of directly-related clinical data management experience and a
minimum of 3 years of experience as a lead Clinical Data Manager. Clinical data
management experience may substitute for a portion of the post-secondary
educational requirements.
· Overall understanding of International Conference on Harmonisation (ICH) Good
Clinical Practice (GCP) guidelines and other applicable regulatory rules and
guidelines as well as of medical terminology, clinical trials, and clinical research.
· Skilled in use of computer technology, including clinical trial databases and
applications (e.g., ClinTrial, Inform) and ability to learn new applications.
· Detailed understanding of project planning and management methods.
· Excellent interpersonal, communication, and organizational skills with the ability
to work independently and in a team environment.

Submit Your Resume

If you would like to be considered for a position at Veristat, please submit your resume to Human Resources at hr@veristat.com