Clinical Supplies/IVRS Coordinator

Clinical Supplies/IVRS Coordinator:

 

The Clinical Supplies/IVRS Coordinator will work with project management and clinical data management to manage the operational aspects of clinical studies. Responsibilities include coordinating the deployment of an Integrated Voice Response System (IVRS), monitoring inventory of study-related supplies at clinical sites, reconciling data received from external sources against the case report forms, and providing support to investigators’ sites during clinical studies.

 

Company Description:

 

Numoda is a life sciences products and services company. We provide products and drug development services in multiple therapeutic areas, Phases I - IV, from protocol design to final report and electronic submission to the FDA. This includes complete and continuous clinical and project management, improved data quality and integrity, for faster reporting and submission.

 

Numoda offers a unique blend of custom data management and trial management products combined with the services of a highly motivated team dedicated to delivering high quality, efficient clinical studies. Our approach and environment challenges the status-quo of study management, allowing creative thinkers to apply new concepts and ideas. Our electronic tools for trial management and data management have received rave reviews from sites, monitors, data managers and sponsors alike. As our client base continues to expand, we are seeking a dedicated Project Manager to coordinate with a variety of vendors and manage the integration of data from multiple external sources into our clinical database.

 

General Duties:

 

-  Support clinical sites with information about current studies.

-  Collect, organize, and maintain project documentation.

-  Gathering and definition of overall project functional requirements.

-  Development and maintenance of project schedules, and responsibility for schedule follow through.

-  Functional design of Integrated Voice Response Systems, and maintenance of related documentation.

-  Oversight of inventory control activities for all study-related supplies.

-  Definition of transfer mechanisms for data to be received from external sources.

-  Reconciliation of data received from external vendors.

-  Training of system users at Investigator Meetings and Clinical Sites.

-  Ongoing user support throughout the study duration, including maintaining a call log of contact with clinical sites.

-  Recommending and implementing process improvements.

 

Essential Skills:

 

-  Ability to communicate with clients and clinical sites in a professional manner.

-  Ability to interface with software development staff.

-  Ability to handle multiple tasks to support the overall requirements of customer projects in an organized fashion.

-  Ability to interact and communicate in English (verbal and written) with team members and management.

-  Ability to document and report all issues according to corporate standard operating procedures

 

Qualifications:

 

-  Experience with supply chain or inventory management.

-  Experience at a CRO, Clinical Site, Pharmaceutical or Medical Device company involved with clinical trials. 

-  Basic knowledge of clinical trial processes.

-  Strong computer operating skills

-  Associates or Bachelors degree in a science, clinical or technical area.

 

Additional Qualifications (not required):

 

-  Experience with Pharmaceutical Industry requirements for 21 CFR Part 11.

-  Experience with SAS and SQL Server

 

General:

 This is a regular salaried position with our company at our Philadelphia, PA headquarters location. Numoda offers health, dental and 401k plans.