JOB DESCRIPTION

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

QUALIFICATIONS

Required Skills/Experience/Education

• 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.