Clinical Research Project Manager

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Location: Troy, IL (Metro St. Louis)
Department: Clinical Research
Listing Date: 2020-11-23
Position: Clinical Research Project Manager
Job Type: Full-Time
Education Level: Bachelor's Degree
Experience Level: Manager (Manager/Supervisor of Staff)
 
Overview

Work very closely with Contract Research Organization (CRO), Sponsors, medical directors, and other pharmaceutical personnel to facilitate successful study completion.  Oversee that all study protocol objectives are met throughout the duration of a study.  Coordinate with other team members to ensure study protocol deadlines are met and management of data collected during study.

Responsibilities
  • During the implementation of a new study, coordinate with other team members to ensure protocol needs are developed prior to study start date.
  • Provide and remove access to Cloud-based EEG data for all parties necessary, including Central Reader, Sites, and partners.
  • Work with the software engineers to initiate and produce monthly reports, which will then be sent to the CRO to provide information regarding EEGs that have been recorded and read by the Central Reader.
  • Attends teleconferences with sponsor and/or CRO as the representative for Lifelines.
  • Primary contact for managing feedback, concerns, questions, and queries from Sites and/or sponsor/CRO.
  • Works with appropriate parties to ensure accuracy of data and resolve any discrepancies.
  • Assists in Quality Assurance, specific to site-related activities, and communicates with CRO, as well as Monitoring Specialists in findings, resolutions, and outcomes.
  • Communicates study-specific needs to the Clinical Research Monitoring Manager for development of appropriate site training materials.
  • Coordinate with Lifelines IT and site’s IT department to ensure all IT requirements are met prior to sample recording and throughout the duration of the study.
  • Develop and produce study documentation for distribution to sites.
Skill Requirements
  • Communications – Expresses ideas and thoughts verbally; expresses ideas and thoughts in written form; exhibits good listening and comprehension; keeps others adequately informed; selects and uses appropriate communication methods.
  • Problem Solving – Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
  • Managing Customer Focus – Promotes customer focus; establishes customer service standards; provides training in customer service delivery; monitors customer satisfaction; develops new approaches to meeting customer needs.
  • Project Management – Develops project plans; coordinates projects; communicates changes and progress; completes projects on time and budget; manages project team activities.
  • Judgement – Displays willingness to make decisions; exhibits sound and accurate judgment; supports and explains reasoning for decisions; includes appropriate people in decision-making process; makes timely decisions.
  • Dependability – Follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time or notifies appropriate person with an alternate plan.

Language Skills:

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.  Ability to write reports, business correspondence, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills:

Extensive knowledge of Microsoft Office and Adobe products.  Advanced computer skills (i.e. installing software, copying files, and basic networking). Ability to understand highly technical medical software and hardware functions to assist in troubleshooting of equipment utilized in the trials as needed.

Additional Skills or Background Desired:

R.EEG.T or CLTM registry is desired. 

1-3 years of clinical research experience managing global trials to include compliance and data management.

Knowledge of HIPAA, ICH-GCP, 21 CFR 11, GDRP, and other applicable regulations. 

Other

To apply for a position with Lifelines Neurodiagnostic Systems, Inc., please complete our Employment Application.  

At the end of the application, simply click on "Email" to return the completed application to Tina Jukich at tina.jukich@lifelinesneuro.com.

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