Site Payment Analyst
ICON plc
REMS Project Manager
UBC
full-time
Posted on:
Origin: • 🇺🇸 United States • Pennsylvania
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Plan, organize and lead UBC project teams to deliver projects based on client needs on time, on budget, and within scope
- Oversee all aspects of project conduct from start-up through close-out
- Execute operational aspects of assigned project activities as well as special projects
- Manage project per the scope of work and within the contracted budget
- Manage revenue and invoicing for project(s)
- Ensure project is conducted according to UBC SOPs and client SOPs as applicable
- Develop plans and processes to achieve contracted milestones (e.g. project plan, clinical management plan, monitoring plan, training plan, communication plan, compliance plan); monitor project progress against the established plans and ensure compliance with plans
- Prepare project timelines and prepare or coordinate development of deliverables
- Prepare project meeting agendas and create minutes and actions logs
- Ensure project budget is tracked against contract milestones
- Serve as UBC primary contact with sponsor
- Coordinate and facilitate all project meetings with internal and external stakeholders as necessary
- Focal point for resolving project team member questions
- Supervise all functional areas that support the project
- Lead projects with cross functional involvement and supervise all functional areas that support the project
- Ensure project training occurs and assist with training for project, as assigned
- Develop content and lead Kick off Meetings both internally and externally
- Negotiate budgets and assist with remediation of contract language
- Present project information at bid defenses, client meetings and UBC monthly project review meetings
- Maintain project documentation to be “audit ready”
- Participate in sponsor/regulatory audits as required
- Coordinate investigator meeting as required
- May be asked to assist in protocol development and/or patient/subject consent form or REMS and REMS Supporting Documents as required
- Help lead process improvement activities
- Establish, implement and track key metrics to report on progress of project and initiatives
- Coordinate and ensure maintenance of Trial Master File as required
- May be asked to perform CSS and CRA duties as needed
- Other duties as assigned by management
- Supervision of project team
Requirements
- Bachelor’s Degree or equivalent experience
- Previous managerial, or relevant experience, required
- Very good written verbal and non-verbal communication skills
- Very good supervisory skills
- Very good interpersonal skills
- Very good presentation skills
- Ability to independently assess issues and/or mitigate risk by using critical judgment to come to a resolution
- Solution driven
- Very good knowledge of regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.)
- 10% travel as required
