REMS Project Manager

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

📋 Description

• Plan, organize, and lead project teams at UBC to successfully deliver projects that meet client needs, adhering to timelines, budgets, and scope.

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

• Manage operational components of assigned project activities and special initiatives.

• Ensure projects are managed within the agreed scope of work and budget constraints.

• Handle project revenue and invoicing processes.

• Guarantee compliance with UBC and relevant client Standard Operating Procedures (SOPs).

• Develop and monitor comprehensive project plans and processes, including clinical management, monitoring, training, communication, and compliance strategies.

• Create project timelines and coordinate deliverables effectively.

• Draft meeting agendas, minutes, and action items.

• Act as the primary contact for sponsors at UBC.

• Organize and facilitate internal and external project meetings.

• Address any questions from project team members.

• Supervise both functional areas and cross-functional project teams.

• Ensure training for project staff and provide necessary assistance.

• Develop content and lead both internal and external kickoff meetings.

• Negotiate budgets and assist in refining contract language.

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

• Maintain documentation that is ready for audit purposes.

• Participate in sponsor and regulatory audits as needed.

• Coordinate investigator meetings as required.

• Assist in the development of protocols and patient/subject consent forms or REMS documentation as necessary.

• Lead initiatives aimed at process improvement.

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

• Coordinate and manage the Trial Master File as necessary.

• Execute CSS and CRA responsibilities as needed.

• Perform additional duties assigned by management.

• Supervise the project team.

⛳️ Requirements

• Bachelor’s Degree or equivalent professional experience.

• Prior managerial or relevant experience is required.

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

• Strong supervisory capabilities.

• Exceptional interpersonal skills.

• Proficient presentation skills.

• Ability to independently assess issues and mitigate risks, using critical judgment to arrive at solutions.

• Solution-oriented mindset.

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

• Willingness to travel up to 10% as necessary.

🏝️ Benefits

• Opportunities for remote work.

• Competitive salary packages.

• Opportunities for career advancement.

• 401K plan with company matching*

• Tuition reimbursement programs.

• Flexible work environment.

• Discretionary Paid Time Off (PTO).

• Paid holidays.

• Employee assistance programs.

• Comprehensive medical, dental, and vision insurance.

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

• Telemedicine services (virtual doctor consultations).

• Wellness programs.

• Adoption assistance.

• Short-term disability coverage.

• Long-term disability coverage.

• Life insurance benefits.

• Various discount programs.