Clinical Data Project Manager

Clinical Data Project Manager:

 

The Clinical Data Project Manger will be responsible for all areas of project management related to the implementation of EDC based clinical studies. Such responsibilities include requirements gathering from the customer to planning, scheduling internal resources for eCRF programming, data management, training materials as well as being the primary project interface for our Pharmaceutical customers for selected projects.

 

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.

General Duties:

 

-  Primary liaison to pharmaceutical and medical device customers, including other vendors (CRO, Labs, ECG, IVRS) that may be associated with the project.

-  Gathering and development of overall project functional requirements.

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

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

-  Assume responsibility of data ownership though the course of a project.

-  Recommend and implement process improvements.

 

Essential Functions:

 

-  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 understand both clinical and technical issues as they relate the management of a clinical study.

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

 

Qualifications:

 

-  5+ years clinical trial project experience at a CRO, Pharmaceutical or Medical Device company.

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

 

Additional Qualifications:

 

 

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

-  Experience SAS and SQL Server

-  Experience with EDC systems used in clinical studies

 

General:

 

Numoda is headquartered in Philadelphia, and this position will be based in that office. Our benefits package includes comprehensive health, dental and 401k plans. We are not offering relocation or sponsorship for this position.