Senior Clinical Data Manager Job in Holliston 01746, Massachusetts US
Summary of Job Responsibilities:
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 enviornment.
To be considered for this opportunity please submit resume and salary requirements via email to:
winde@irionline.com