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Patients First. Powered by Evidence.
REMS Project Manager
Location
United States
Posted
4 days ago
Salary
0
Seniority
Senior
Job Description
REMS Project Manager
UBC
• 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
Job 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
Benefits
- Remote opportunities
- Competitive salaries
- Growth opportunities for promotion
- 401K with company match*
- Tuition reimbursement
- Flexible work environment
- Discretionary PTO (Paid Time Off)
- Paid Holidays
- Employee assistance programs
- Medical, Dental, and vision coverage
- HSA/FSA
- Telemedicine (Virtual doctor appointments)
- Wellness program
- Adoption assistance
- Short term disability
- Long term disability
- Life insurance
- Discount programs
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