[Hiring] REMS Project Manager @United Biosource Corporation

Role Description

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.

Qualifications

• 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.