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The Clinical Data Manager II is responsible for the performance of data management tasks from study start-up through database lock for assigned projects within electronic data capture (EDC) systems.
S / he is responsible for the creation of CRFs, programming of edit checks, facilitating User Acceptance Testing (UAT), data cleaning, query generation and management, and development of relevant data management documents.
The Clinical Data Manager II is responsible for overall data quality and documentation on assigned studies.
The Clinical Data Manager II will work on mid to large sized 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 Veristat and / or Sponsor specific requirements.
In consort with Data Management leadership, the Clinical Data Manager II promotes consistent operations, efficient use of resources, and sharing of knowledge and best practices.
S / he, in consultation with the managers, will assist with the training of other data managers on project specific and general data management processes, procedures and systems.
As a Clinical Data Manager II You Will
Lead studies as the Lead Clinical Data Manager; liaise between study personnel and the client, as appropriate, regarding clinical and / or technical issues.
May also serve as support for other Lead Clinical Data Managers as needed
Develop and / or review case report forms (CRFs) within an EDC system
Author or perform quality control review of data management documents, such as CRF Completion Guidelines (CCGs), Data Management Plans (DMP), and Data Transfer Plans
Develop or quality control review Data Validation Specifications (DVS) document
Participate in programming edit checks and other system functions within EDC as needed
Facilitate or participate in User Acceptance Testing (UAT) prior to study go-live
Responsible for data Cleaning activities including data review, query generation and management, and development of study metrics.
May find discrepancies, track trends, and identify areas of retraining needed from members of the study team
Responsible for the handling and reconciliation activities of external data (e.g., Central Labs, IVRS, etc.)
Oversee or participate in database Lock activities, including managing user access and authoring or providing quality control review of lock documentation
Work with other functional groups (e.g., Biostatistics, Statistical Programming, Medical Writing, Project Management, etc.
to ensure data management aspects of the project are properly considered and integrate well with the other activities
May provide mentorship or training opportunities for junior level staff within the Data Management department
Serve in a Project Management capacity as deemed necessary and appropriate
Experience + Requirements
Bachelor’s degree in a related field & 4 years of experience in clinical data management required OR Master’s degree & 3 years of experience in clinical data management.
2 years of experience in leading project teams required.
Working knowledge 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., IBM Clinical Development, Medidata RaveEDC) and ability to learn new applications.
Good understanding of project planning and management methods.
Excellent interpersonal, communication, and organizational skills with the ability to work both independently and in a team environment.