Clinical Project Research Manager - 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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Clinical Project Research Manager - EDS/RWE/NIS

UBC / EDS / PD/PM - WPK Regular Research & Clinical Remote, US

As a pharmaceutical support industry leader , UBC is devoted to empowering health solutions for a better tomorrow . We take pride in improving patient outcomes and advancing healthcare. At UBC we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.

Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity.

If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

Job Title: YLM01H - Clinical Project Research Manager

Brief Description : Plan, organize, and lead UBC project teams to deliver projects based on client needs on time, on budget, and within scope.

Specific job duties:

• 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

Supervisory Responsibility: Supervision of project team

Desired Skills and Qualifications:

• Bachelor’s Degree or equivalent experience
• Previous managerial, or relevant experience, required
• Excellent supervisory, interpersonal, and presentation skills
• Ability to independently assess issues and/or mitigate risk by using critical judgment to come to a resolution
• Knowledge of regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.)
• 10% travel as required

At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally.

Here are some of the exciting perks UBC offers:

• Remote opportunities
• Growth opportunities for promotion
• 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

UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.