REMS Project Manager

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

📋 Description

• Plan, organize, and lead UBC project teams to ensure timely, budget-conscious, and scope-compliant delivery of projects according to client needs.

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

• Execute the operational components of assigned project activities and special initiatives.

• Manage projects in alignment with the defined scope of work and contracted budget.

• Oversee project revenue and invoicing processes.

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

• Develop project plans and processes to meet contracted milestones effectively.

• Monitor project progress and ensure compliance with established plans.

• Prepare project timelines and coordinate the delivery of project outputs.

• Draft meeting agendas, minutes, and action logs as needed.

• Track project budgets against contract milestones to ensure financial integrity.

• Act as the primary contact for sponsors within UBC.

• Coordinate and facilitate both internal and external project meetings.

• Address queries from project team members promptly.

• Supervise functional areas that support projects and lead cross-functional initiatives.

• Ensure proper training for project teams and assist with training initiatives.

• Develop content and lead both internal and external Kickoff Meetings.

• Negotiate budgets and support contract language remediation processes.

• Present project information during bid defenses, client meetings, and monthly project reviews.

• Maintain project documentation to be audit-ready at all times.

• Participate in sponsor and regulatory audits as necessary.

• Coordinate investigator meetings as required.

• Assist with protocol development, patient/subject consent forms, Risk Evaluation and Mitigation Strategies (REMS), and REMS Supporting Documents as necessary.

• Lead initiatives for process improvement.

• Establish, implement, and monitor key project and initiative metrics.

• Coordinate and ensure the maintenance of the Trial Master File.

• Perform Clinical Study Site (CSS) and Clinical Research Associate (CRA) duties as needed.

• Undertake additional duties as assigned by management.

• Supervise project team members effectively.

⛳️ Requirements

• Bachelor’s Degree or equivalent relevant experience.

• Previous managerial or relevant experience is required.

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

• Strong supervisory skills.

• Exceptional interpersonal skills.

• Proficient presentation skills.

• Ability to independently evaluate issues and/or mitigate risks using critical judgment for effective resolution.

• Solution-oriented mindset.

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

• Willingness to travel up to 10% as required.

🏝️ Benefits

• Opportunities for remote work.

• Competitive salary packages.

• Opportunities for career advancement.

• 401K with company match.

• Tuition reimbursement programs.

• Flexible working 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).

• Telemedicine services for virtual doctor appointments.

• Wellness programs.

• Adoption assistance programs.

• Short-term disability insurance.

• Long-term disability insurance.

• Life insurance coverage.

• Discount programs available.