Associate Clinical Data Manager

Conteúdo do emprego

Description

For more than 25 years, Veristat has built a reputation as a thoughtful partner in the clinical development and regulatory submission process. We have done so by hiring talented people who align to our core values and share a common passion for our mission driven work.

Do you value a collaborative work environment and the opportunity to truly make a difference? If so, you will feel right at home here. At Veristat, you can grow both personally and professionally, with opportunities to discuss your achievements and advance your career through quarterly feedback conversations and meaningful work.

We do things differently than large CROs and would love to have you join our Veristat team!

Working under close supervision, the Associate Clinical Data Manager is responsible for supporting the Lead Clinical Data Manager on clinical research projects. S/he is responsible for the quality control of design aspects of building studies in electronic data capture (EDC) systems, user acceptance testing, data cleaning and reconciliations, and query generation and management. The Associate Clinical Data Manager may also assist in the QC of data management documents such as the Data Management Plan and CRF Completion Guidelines.

The Associate Clinical Data Manager will simultaneously work on numerous projects in varying indications, supporting diverse team members within the Data Management department.

As an Associate CDM You Will...

• Review data within EDC to find discrepancies, track trends, identify areas of retraining needed from members of the study team.
• Perform data Reconciliation activities (external datasets to EDC, SAE reconciliation, lab reconciliations) and follow up on actions needed.
• Oversee discrepancy identification, query generation and management in EDC
• Manage laboratory normals from sites – tracking progress/completeness and cleaning subsequent lab data in EDC as needed.
• Run ad-hoc or planned study reports.
• Lead user Maintenance activities in EDC – managing rights to the system and tracking training requirements as needed.
• Maintain Project Issue Logs and participate in cross-functional communication between departments such as Biostatistics, Programming, Data Standards, and Clinical Monitoring, to ensure issues/discrepancies are documented and resolved across all areas.
• Assist with User Acceptance Testing with EDC.
• Serve as quality control reviewer or author for documents such as Data Management Plans (DMP), CRF Completion Guidelines (CCGs), Data Transfer Agreements (DTAs), etc.
  

Experience & Minimum Requirements

• Bachelor’s degree in a related field required.
• General knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines preferred.
• Skilled in use of computer technology, a general knowledge of CDASH/SDTM, and ability to learn new applications
• Strong understanding of relational databases
• Excellent interpersonal, communication, problem solving and organizational skills with the ability to work both independently and in a team environment