Job Summary: The Project Management Specialist is responsible for maintaining project files and study information on Elligo Systems.
While collaborating with the Vice President of Project Management and Project Managers, the Project Management Specialist ensures communication between external stakeholders is up to date and that data is accurately reported.
Supervisory Responsibilities None specified.
Responsibilities: Set up, maintain, and close out project files and study information (e.g., regulatory documents, Investigator Site File (eISF), enrollment, protocol deviations, site supplies, Institutional Review Board re-approvals, data queries) on Elligo systems and client systems if applicable.
Maintain and distribute study-specific financial reports (e.g., vendor invoices, investigator payments (grants and pass-through), forecasts, etc.).
Lead internal and external meetings as directed by the Project Manager (PM).
Prepare and distribute meeting minutes and action items for both internal and external meetings.
Follow up with team members on action items to closure.
Record the status of milestones and key performance indicators, with input and oversight from the assigned PM.
Assess and communicate key performance indicators for associated job tasks to PM with proposed action plan.
Prepare and provide status reports to customers with oversight from assigned PM.
Ensure all study documents are filed in eISF as required based on the appropriate guidelines and policy.
Complete periodic reviews of the eISF to ensure completeness and quality.
Serve as project representative for internal and external audits.
Provide support for quality assurance activities, including preparation for audits and internal review, preparing documentation and follow through to resolution of actionable issues.
Serve as primary customer contact when PM is out of the office.
Seek input from Director for customer support.
Manage customer relationships by: Effectively communicating project-specific reports to external stakeholders in accordance with strategic objectives of the organization.
Acting as a liaison between customer and Elligo's Research Operations.
Initiating collaboration with the appropriate individuals and/or departments within the client's organization.
Building positive customer relationships.
Knowledge, Skills, and Abilities Required: BS/BA in Life Science or related discipline.
1+ year clinical research experience preferred (including Study Coordinator, CRO experience).
Previous GCP training and certification a plus.
Demonstrated ability in positive relationship building, with strong verbal and written skills required.
Strong interpersonal skills with attention to detail a must.
Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial master filing systems.
Strong organization/prioritization skills for the management of multiple concurrent projects.
Working Conditions: This job operates in a professional office environment.
This role routinely uses standard office equipment such as computers, phones, and photocopiers.
Some flexibility in hours is allowed, but the employee must be available during the core work hours of 9:30 a.m. to 3:30 p.m. and must work 5 hours each week to maintain full-time status.
Occasional evening and weekend work may be required as job duties demand.
Travel: Minimal.
The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position.
They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel.
More in-depth information can be found in SOPs, working guidelines, policies, etc.
Elligo is committed to the principle of equal employment opportunity for all employees.
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