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-friendly, and scope-compliant project delivery based on client requirements.

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

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

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

• Handle project revenue and invoicing processes.

• Ensure compliance with UBC and relevant client Standard Operating Procedures (SOPs) throughout projects.

• Create plans and processes aimed at achieving contracted milestones.

• Monitor project advancement and adherence to established plans.

• Develop project timelines and manage deliverable coordination.

• Prepare meeting agendas, and document minutes and action logs.

• Track project budgets in relation to contract milestones.

• Act as UBC’s main point of contact for sponsors.

• Coordinate and facilitate both internal and external project meetings.

• Address inquiries from project team members.

• Supervise functional areas that support projects and cross-functional project teams.

• Ensure project training is conducted and assist with training initiatives.

• Create content and lead internal and external kick-off meetings.

• Negotiate budgets and assist with contract language revisions.

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

• Maintain project documentation that is ready for audit.

• Participate in sponsor and regulatory audits as needed.

• Coordinate investigator meetings as required.

• Assist with the development of protocols, patient/subject consent forms, Risk Evaluation and Mitigation Strategies (REMS), and related documents.

• Lead initiatives for process improvement.

• Establish, implement, and monitor metrics for projects and initiatives.

• Coordinate and ensure the upkeep of the Trial Master File as necessary.

• Perform Clinical Site Specialist (CSS) and Clinical Research Associate (CRA) duties as required.

• Undertake additional responsibilities assigned by management.

• Supervise the project team.

⛳️ Requirements

• Bachelor’s Degree or equivalent experience is required.

• Prior managerial or relevant experience is necessary.

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

• Strong supervisory abilities.

• Exceptional interpersonal skills.

• Proficient presentation skills.

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

• Solution-oriented mindset.

• In-depth knowledge of regulatory requirements (e.g., Good Clinical Practice, ICH guidelines, etc.).

• Willingness to travel up to 10% as needed.

🏝️ Benefits

• Opportunities for remote work.

• Competitive salary packages.

• Opportunities for career advancement.

• 401K plan with company matching.*

• 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 (virtual doctor appointments).

• Wellness programs.

• Adoption assistance.

• Short-term disability coverage.

• Long-term disability coverage.

• Life insurance benefits.

• Access to discount programs.