REMS Project Manager

As a pharmaceutical support industry leader, UBCis devoted toempowering health solutions for a better tomorrow. We takeprideinimprovingpatient outcomes andadvancing healthcare.At UBCwe 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 meaningfulimpacton theworldaround you.UBCfosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in aninclusive workplacethat fosters creativity.

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
• Very good written verbal and non-verbal communication skills
• Very good supervisory skills
• Very good interpersonal skills
• Very good presentation skills
• Ability to independently assess issues and/or mitigate risk by using critical judgment to come to a resolution
• Solution driven
• Very good knowledge of regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.)
• 10% travel as required