Remote Clinical Project Lead – EDS/RWE/NIS

University of British Columbia; United States; Remote; USD 110,000 - 160,000; Full time

Benefits offered by this job

Remote opportunities

401K with company match*

Flexible work environment

Discretionary Time Off

Paid Holidays

Employee assistance programs

Medical, Dental, and vision coverage

HSA/FSA

Wellness program

Adoption assistance

Short term disability

Long term disability

Life insurance

Job summary

UBC is seeking a Clinical Project Research Manager to lead multi-disciplinary teams delivering trials on time, within budget, and in scope. This role supports EDS/RWE/NIS initiatives across remote US operations, requiring strong project management and regulatory knowledge.

As a key sponsor liaison, you will oversee start-up through close-out, manage budgets, develop plans, and ensure audit-ready documentation while fostering collaboration and continuous improvement across functions.

Qualifications

• Bachelor’s Degree or equivalent experience.
• Previous managerial experience required.
• Excellent supervisory, interpersonal, and presentation skills.
• Ability to independently assess issues and mitigate risk by using critical judgment to come to a resolution.
• Knowledge of regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.)

Responsibilities

• Oversee all aspects of project conduct from start-up through close-out.
• Execute operational aspects of assigned project activities as well as special projects.
• Manage project per the scope of work and within the contracted budget.
• Manage revenue and invoicing for project(s).
• Ensure project is conducted according to UBC SOPs and client SOPs as applicable.
• Develop plans and processes to achieve contracted milestones (e.g. project plan, clinical management plan, monitoring plan, training plan, communication plan, compliance plan); monitor project progress against the established plans and ensure compliance with plans.
• Prepare project timelines and prepare or coordinate development of deliverables.
• Prepare project meeting agendas and create minutes and actions logs.
• Ensure project budget is tracked against contract milestones.
• Serve as UBC primary contact with sponsor.
• Coordinate and facilitate all project meetings with internal and external stakeholders as necessary.
• Focal point for resolving project team member questions.
• Supervise all functional areas that support the project.
• Lead projects with cross functional involvement and supervise all functional areas that support the project.
• Ensure project training occurs and assist with training for project, as assigned.
• Develop content and lead Kick off Meetings both internally and externally.
• Negotiate budgets and assist with remediation of contract language.
• Present project information at bid defenses, client meetings and UBC monthly project review meetings.
• Maintain project documentation to be “audit ready”
• Participate in sponsor/regulatory audits as required
• Coordinate investigator meeting as required
• May be asked to assist in protocol development and/or patient/subject consent form or REMS and REMS Supporting Documents as required
• Help lead process improvement activities
• Establish, implement and track key metrics to report on progress of project and initiatives
• Coordinate and ensure maintenance of Trial Master File as required
• May be asked to perform CSS and CRA duties as needed
• Other duties as assigned by management

Skills

Management experience

Supervisory skills

Presentation skills

Regulatory knowledge

Risk assessment

Education

Bachelor's degree

Job description

UBC is seeking a Clinical Project Research Manager to lead multi-disciplinary teams delivering trials on time, within budget, and in scope. This role supports EDS/RWE/NIS initiatives across remote US operations, requiring strong project management and regulatory knowledge.

As a key sponsor liaison, you will oversee start-up through close-out, manage budgets, develop plans, and ensure audit-ready documentation while fostering collaboration and continuous improvement across functions.