Project Manager, IRT Study Implementation

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POST DATE 9/20/2017
END DATE 12/21/2017

BioClinica New London, CT

New London, CT
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree



Build and manage study configurations within IRT systems by:

* Reviewing study designs and identifying challenges that may arise when translating the study into the IRT system

* Coordinating kickoff and ongoing meetings as needed with study team and supply chain representatives

* Determining IRT implementation plans for studies, including identification and design of necessary study specialization to be provided by the IRT software team when applicable

* Working with supply chain to identify resupply plans and configuration

* Consolidating study implementation details into a final study implementation document

* Coordinating with software team to schedule specialization deployments when required

* Building studies in a validation environment

* Demoing studies in the validation environment to the study team

* Coordinating feedback from demos and reworking study implementation if necessary

* Ensuring approval and formal signoff of study implementation documents by study team and other signatories as needed

* Overseeing and/or executing User Acceptance Testing of studies in the validation environment

* Coordinating the move of study configuration from the validation environment to production environment

* Validating study implementations in production match corresponding implementation documents by performing and coordinating Quality Checks

* Managing the import of drug and ensuring it is properly mapped to the IRT implementations

* Overseeing the transition of live studies to the clinical studies support teams

* Ensuring that clinical site users have been supplied with appropriate training materials for the use of the IRT system and the studies in which they are participating

* Creating custom reports for end user &/or business units as requested

* Assisting in or leading the training of less experienced support team members

* Once fully trained, providing in-depth business and client process knowledge to all implementation and support team members as needed

* Leading small groups of resources and assisting in the management of client support teams


* Associates/Bachelor s degree or suitable related job experience


* 2+ years experience implementing studies in clinical IRT systems

* Proven customer service skills

* Detailed understanding of the Pharmaceutical environment, especially as pertaining to Clinical Study management and related processes

* Detailed understanding of IRT systems

* Detailed understanding of clinical study implementation process

* Familiarity with regulatory requirements related to Clinical Study operations (including GCP, GMP, and GDP)

Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.