Project Management Specialist (Remote)
- Job Title
- Project Management Specialist (Remote)
- Job ID
- 27690953
- Location
- Remote,
- Other Location
- Description
-
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.
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“I am super passionate about what we are doing at Elligo and feel so fortunate to be a part of it! I haven’t been this excited about a job in years!”
“Having been involved in clinical research for over 10 years, I have found the Elligo model to be truly innovative. From top to bottom, the Elligo team is made up of professionals who use their experience and knowledge to positively affect the need to bring healthcare and clinical research together.”
“Elligo is at the forefront of innovation in the clinical research industry. It’s rewarding to work among such highly motivated and distinguished leaders and visionaries. I start work each day feeling valued and end each day excited to be part of Elligo’s influence on changing the clinical research industry.”
“Working at Elligo has been a very unique experience. I love the fact that I’m surrounded by colleagues who help me learn something new every day. I value their experience and genuinely enjoy the work and projects we are involved with. I love coming to work every day!”