REMS Project Manager

This position is offered fully home-based (remote). As a pharmaceutical support industry leader, UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBC, we provide services to enhance the entire drug development process and commercialization lifecycle—from clinical trial support to real-world evidence generation.

About the role

Plan, organize, and lead UBC project teams to deliver projects based on client needs on time, on budget, and within scope.

Responsibilities

• 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 meetings 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

Requirements

• Bachelor’s Degree or equivalent experience
• Previous managerial or relevant experience
• 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