REMS Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Plan, organize, and manage UBC project teams to ensure timely, budget-friendly, and scope-compliant project delivery based on client requirements.

• Oversee all phases of project execution from initiation to completion.

• Implement operational components of assigned project activities and special projects.

• Manage projects according to the defined scope of work and within the agreed budget.

• Oversee revenue generation and invoicing for the project(s).

• Ensure project execution adheres to UBC Standard Operating Procedures (SOPs) and client SOPs where applicable.

• Develop plans and processes to meet contractual milestones (e.g., project plan, clinical management plan, monitoring plan, training plan, communication plan, compliance plan); track project progress against established plans and ensure adherence.

• Create project timelines and organize or coordinate the development of deliverables.

• Draft project meeting agendas and maintain minutes and action logs.

• Monitor project budget in relation to contract milestones.

• Act as UBC's primary liaison with sponsors.

• Organize and facilitate all project meetings with internal and external stakeholders as needed.

• Serve as the main point of contact for resolving inquiries from project team members.

• Supervise all functional areas that support the project.

• Lead projects involving cross-functional collaboration and oversee all supporting functional areas.

• Ensure project training is conducted and assist with training for the project as needed.

• Develop content and lead Kick-off Meetings both internally and externally.

• Negotiate budgets and assist in the refinement of contract language.

• Present project information during bid defenses, client meetings, and UBC's monthly project review sessions.

• Maintain project documentation to ensure it is “audit ready.”

• Participate in sponsor/regulatory audits as required.

• Coordinate investigator meetings as necessary.

• May assist in protocol development or the creation of patient/subject consent forms, REMS, and REMS Supporting Documents as needed.

• Contribute to process improvement initiatives.

• Establish, implement, and monitor key metrics to report on project and initiative progress.

• Manage and ensure the upkeep of the Trial Master File as required.

• May be requested to perform CSS and CRA duties when necessary.

• Undertake other responsibilities as assigned by management.

⛳️ Requirements

• Bachelor’s Degree or equivalent experience is required.

• Previous managerial or relevant experience is essential.

• Excellent written, verbal, and non-verbal communication skills.

• Strong supervisory capabilities.

• Exceptional interpersonal skills.

• Proficient presentation skills.

• Ability to independently evaluate issues and/or mitigate risks using critical judgment to reach resolutions.

• Solution-oriented mindset.

• Solid understanding of regulatory requirements (e.g., Good Clinical Practice, ICH guidelines, etc.).

• Willingness to travel up to 10% as needed.

🏝️ Benefits

• Remote working opportunities.

• Competitive salary packages.

• Opportunities for professional growth and advancement.

• 401K plan with company matching.*

• Tuition reimbursement options.

• Flexible work environment.

• Discretionary Paid Time Off (PTO).

• Paid holidays.

• Employee assistance programs.

• Comprehensive medical, dental, and vision coverage.

• Health Savings Account (HSA) and Flexible Spending Account (FSA) options.

• Telemedicine services (virtual doctor consultations).

• Wellness programs.

• Adoption assistance.

• Short-term disability insurance.

• Long-term disability insurance.

• Life insurance coverage.

• Discount programs available.