• Job Description

  Req#: 27688522
  I. JOB SUMMARY The Project Management Specialist is responsible for maintaining project files and study information on Elligo Systems. While collaborating with Vice President, Project Management and Project Managers, the Project Management Specialist ensures communication between external stakeholders is up to date and that data is accurately reported.
  
  
  II. SUPERVISORY RESPONSIBLITIES
  
  III. RESPONSIBILITES
  • 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).
  • May lead internal and external meetings as directed by the Project Manager (PM)
  • Prepares and distributes meeting minutes and action items for both internal and external meetings
  • Follows up with team members on action items to closure.
  • Records the status of milestones and key performance indicators, with input and oversight from the assigned PM.
  • Assesses and communicates key performance indicators for associated job tasks to PM with proposed action plan.
  • Prepares and provides 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.
  • Completes periodic reviews of the eISF to ensure completeness and quality
  • May 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 actionable issues.
  • May serve as primary customer contact when PM is out of the office. Seeks input from Director for customer support.
  • Manages customer relationships by:
  • Effectively communicating project specific reports to external stakeholders in accordance with strategic objectives of the organization
  • Acting as a liason between customer and Elligo’s Research Operations
  • Initiating collaboration with the appropriate individual(s) and/or department(s) within the client’s organization
  • Building positive customer relationships
  
  
  IV. 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
  
  
  V. 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 37.5 hours each week to maintain full-time status. Occasional evening and weekend work may be required as job duties demand.
  
  Travel: Minimal
  
  he 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 SOP's, working guidelines, policies, etc.
  
  Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.

• About the company

  Elligo Health Research’s Goes Direct® approach brings clinical research direct to clinical health care, reinventing research as care for quality clinical trials.

Notice