Assistant Project Manager - REMOTE ROLE

MERIT CRO, Inc.•Madison, WI

1d•Remote

About The Position

MERIT CRO, Inc. is a global clinical trial endpoint expert specializing in multiple therapeutic areas. We are committed to making a difference and are seeking talented people to join our team. Collaboration and customer focus are at the core of everything we do. We value diversity and are interested in people with drive, dedication, and creative problem-solving skills. We offer flexible schedules and remote opportunities. Assists the Project Management Division with the coordination and conduct of project management activities, including the creation and distribution of study-related documents and the coordination of study activities. Carries out management directives in a professional, efficient, and thorough manner. 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).

Requirements

BA or BS degree from a four-year college or university
Some related experience and/or training in administrative or customer service, preferably in a health care or service-related environment, or equivalent combination of education and experience.
Strong interpersonal and organizational skills
Excellent attention to detail
Ability to follow direction
Assess Company needs and work independently.
Computer skills to include proficiency in Microsoft Office software
Ability to learn Company specific software.
Must be able to project a professional attitude and image appropriate for the work environment.
Ability to participate and contribute to a team environment as a team member.
Oral and written communication is clear, concise, and effective.

Nice To Haves

Preferred experience in clinical trial or project management in a related field.

Responsibilities

Manage office tasks including organization and coordination of controlled documents
Assist with all aspects of study management
Assist in the development of project and regulatory documents; includes proofreading of documents
Assist in the creation, duplication, and dissemination of documents.
Assist with responses to quality review audits
Assist with the development/implementation of training programs
Monitor own work to ensure quality and completeness
Assist with all study activities from start-up through close out
Organize 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.
Assist with the development of new study specific processes and procedures
Initiation of Master Project File and maintenance of project documents
Generate and email eligibility reports and notifications
Attend project meetings internally and with sponsors (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.
Assist with generating study reports and assembling data for study updates
Understand the EXCELSIOR™ product, protocol, and conduct of clinical trials in sufficient detail to be able to adequately discuss tasks with study team members
Complete the initial configuration of studies within EXCELSIOR™
Assist with the review of EXCELSIOR™ study specific configuration
Manage and review site surveys, update EXCELSIOR™ for site registration
Assist with providing guidance and training to sponsors, CROs, clinical sites, and graders on the use of EXCELSIOR™, including software functionality and technical support
Clinical site technician and equipment certification
Image check-in and quality control
Issue and review data query responses to ensure completeness and accuracy of response relative to other data
Review, categorize, and respond to customer support and complaint tickets in the helpdesk application
Follow up with sites, sponsors, and reading center personnel on EXCELSIOR access; review inactive user reports
Comply fully with company policies and Standard Operating Procedures (SOPs)
Other responsibilities may be assigned as required