Project Manager - REMOTE Job Iowa USA,Science

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IA, US

SUMMARY:

Accomplishes the day-to-day operations of project management and accurately and competently administers activities regarding assigned studies. Responsible for all study activities; study start up through closeout. Primary functions include assisting project management of clinical trial data in the EXCELSIOR™ cloud application environment; perform data upload, quality control functions; maintenance of controlled documents including Master Project Files; and provide support functions for clinical sites, reading centers and clients using EXCELSIOR™ according to MERIT and/or study specific procedures and Good Clinical Practices (GCP).

ESSENTIAL DUTIES AND RESPONSIBILITIES:

(Other duties may be assigned.) Administrative Duties:

Manage office tasks including organization and coordination of controlled documents
Assist in development of project and regulatory documents; includes proofreading of documents
Respond to quality review audits and clearly document responses to facilitate resolutions
Assist with the development/implementation of training programs
Monitor own work to ensure quality and completeness
Ability to work with limited supervision

Study-Related Duties:

Perform and oversee all study activities from start-up through close out and data lock
Organizes and prioritize work assignments to complete assignments and tasks on time, with quality and has the ability to anticipate problem areas in advance. Apply creative approaches and ideas to solve problems maximizing effective use of appropriate resources.
Prepare study start up materials, organize and conduct internal study start up meeting, and follow up on action items
Establish and maintain routine communication among the Project Management Division, Sponsor, site staff, and other designated parties.
Assist with the development of new study specific processes and procedures
Initiation of Master Project File and maintenance of project documents
Establish study files and create and distribute study documents
Attend project meetings internally and with sponsor (via teleconference or face-to-face) throughout the project
Maintain established study specific systems and procedures for regular status updates, site information lists, revisions of plans or study documents and routine correspondence.
Generate and email eligibility reports and notifications
Generate and provide study reports and updates
Independently process clinical data from start up through database lock prioritizing work to meet project timelines
Responsible for assisting in all aspects of study conduct, initiation through closeout

Software-related Duties:

Understand the EXCELSIOR™ product, protocol and conduct of clinical trials in sufficient detail to be able to adequately discuss tasks with study team members
Provide guidance and training to sponsors, CROs and clinical sites on the use of EXCELSIOR™, including software functionality and technical support
Ensure accurate and efficient set up of EXCELSIOR™ for assigned project(s) through reviews, user acceptance testing, and study specific imaging charter review and development
Complete the initial configuration of studies within EXCELSIOR™
Assist with the review of EXCELSIOR™ study specific configuration
Develop and perform project specific user acceptance testing, involving reading center personnel as applicable
Ensure the internal team is appropriately trained in the use of EXCELSIOR™, and if required, provide additional training support and development
Manage and review site surveys; update EXCELSIOR™ for site registration
Clinical site technician and equipment certification
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