Clinical Project Research Manager – EDS, RWE, NIS

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

📋 Description

• Organize, plan, and lead UBC project teams to successfully deliver projects according to client requirements, within the specified timeline, budget, and scope.

• Supervise all facets of project execution from initiation through to closure.

• Implement operational elements of designated project tasks and special initiatives.

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

• Oversee project revenue and invoicing processes.

• Ensure compliance with UBC and relevant client standard operating procedures (SOPs).

• Develop and track project plans and processes for agreed milestones.

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

• Draft meeting agendas, as well as prepare minutes and action logs.

• Monitor project budgets against contractual milestones.

• Act as the primary UBC liaison with sponsors.

• Organize and facilitate both internal and external project meetings.

• Address inquiries from project team members.

• Oversee cross-functional project support teams.

• Ensure project training is conducted and provide assistance with training initiatives.

• Develop content and lead internal and external kickoff meetings.

• Negotiate budgets and assist with contract adjustments.

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

• Maintain documentation that is ready for audits.

• Participate in sponsor and regulatory audits.

• Coordinate investigator meetings.

• Assist with protocol development and patient/subject consent forms or REMS documentation as necessary.

• Lead initiatives for process improvement.

• Establish, implement, and monitor project metrics.

• Manage and maintain the Trial Master File.

• Execute CSS and CRA responsibilities as required.

• Undertake additional tasks assigned by management.

• Supervise the project team.

⛳️ Requirements

• Bachelor's Degree or comparable experience.

• Previous managerial or relevant experience is required.

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

• Strong supervisory, interpersonal, and presentation abilities.

• Capability to independently evaluate issues and mitigate risks through critical judgment for effective resolution.

• Solution-oriented mindset.

• Understanding of regulatory standards (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 working environment.

• Discretionary Time Off.

• Paid holidays.

• Employee assistance programs.

• Comprehensive medical, dental, and vision insurance.

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

• Access to telemedicine services (virtual doctor appointments).

• Wellness programs.

• Adoption assistance.

• Short-term disability coverage.

• Long-term disability coverage.

• Life insurance benefits.

• Discounts through various programs.