Clinical Research and Data Manager - Boulder, CO or Chicago, IL

Job Description

The Clinical Research & Data Manager will oversee the clinical research function and resulting data from studies. The manger will report to the Director of Marketing & Clinical Research and collaborate effectively with various groups within the organization to ensure study success. This role can be located in Boulder, CO or Chicago, IL.

* Successful execution of clinical trials from the protocol concept through the clinical study report, ensuring completion of study deliverables

* Overseeing each studys clinical processes to ensure proper planning, conduct, patient safety, and data quality, while fostering good communication skills between study sites and sponsor

* Working closely with the Marketing, Research & Development and Regulatory teams

* Assisting with IRB submissions or providing the necessary paperwork to local IRBs for their submissions

* Writing or contributing to clinical protocols, informed consent forms, amendments, study guides, case report forms, and any other clinical research related documents

* Manage CTMF organization, filing and maintenance of documents

* Overseeing performance of CROs, monitors and other third-party clinical vendors to ensure compliance with study protocol and in accordance with scope of work

* Managing CRAs through scheduling, training, and all monitoring activities

* Receiving and performing initial review of CRO and other third-party study vendor invoices

* Tracking progress of all clinical studies and providing timely updates to management

* Managing site initiation visits and any other interim site training, data collection, or troubleshooting that is needed, including planning, preparation and execution

* Ensuring studies are carried out according to the study protocol, SOPs, and latest applicable regulations and guidelines (e.g. ISO, FDA, MDR)

* Managing receipt, entry, and maintenance of CRFs, device recording files, clinical data workbooks and Electronic Data Capture system

* Maintain clinical databases and create queries and reports

* Listing, reporting and maintaining all studies on

* Assisting in abstract and manuscript writing to meet submission deadlines for various publications and conferences

* Managing the maintenance, preparation, and logistics of the device systems used in clinical research studies