REMS Project Manager

United Biosource Corporation•All Virtual Locations, Home Based Position, USA, Remote, US,

1d•Remote

About The Position

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!

Requirements

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.)

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