The Clinical Data Manager (CDM) is responsible for managing data management (DM) activities in the design, administration, data collection, and lock of databases for IDE clinical trials and post-market surveillance studies. As part of the Clinical Research Team, the CDM will play a key role in the clinical team at Active Implants and interface with external CROs and external vendors to fulfill many of his/her responsibilities.
Roles and responsibilities include the following:
- Serve as the Lead Data Manager on multiple studies
- Develop database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations.
- Responsible for double-data entry (DDE) of existing paper CRFs
- Create and maintain project DM documentation (Data Management Plan, etc)
- Develop Case Report Form (CRF), electronic and/or paper.
- Participates in the review of Clinical research documents (eg. Protocols, Case Report Forms, Reports, and Statistical analysis).
- Extract and monitor the trial data to identify issues
- Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- including but not limited to data
reconciliation and/or Manage CDM activities with clinical trial monitors
- Participates in the preparation and presentation of data, when applicable.
- Ensures data system compliance by following the established guidelines of national and international regulatory authorities.
- Participate in conference calls and/or meetings with vendors.
- Mentor or train other junior members
- Minimum of BS preferably in Health Sciences, Statistics, MIS, or Informatics
- Minimum of 2 years of experience in Clinical Data Management from CROs or Medical Device/Pharmaceutical companies
- Experience in electronic data capture (EDC) systems
- Working knowledge of ICH/GCP guidelines, Clinical Research, Clinical Trial process, and FDA regulations
- Working knowledge of Clinical Database applications such as EDC and CTMS
- Knowledge of industry data standards (CDISC, SDTM, CDASH)
- Excellent organizational skills
- Outstanding interpersonal, oral, and written communication skills Desired Skills/Experience
- Applicable knowledge of working with other clinical databases, SAS, and others.
- Experience with working on IDE trials and device registries within the medical device and/or pharmaceutical industry.
- AE Coding, if applicable.