REMS Project Manager

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

2d•Remote

About The Position

The Clinical Project Research Manager plans, organizes, and leads UBC project teams to deliver projects according to client needs, on time, on budget, and within scope. The role oversees project conduct from start-up through close-out, manages operational activities, project budgets, revenue, and invoicing, and ensures work follows UBC and applicable client SOPs. The manager develops and monitors project plans and processes, tracks milestones and metrics, coordinates project deliverables and meetings, and serves as UBC’s primary contact with sponsors. The position supervises project teams and supporting functional areas, maintains audit-ready documentation and Trial Master Files as required, and may contribute to protocol, consent form, REMS, or REMS Supporting Document development. It may also include CSS and CRA duties as needed. Travel of 10% is required.

Requirements

Bachelor’s degree or equivalent experience.
Previous managerial or relevant experience.
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 using critical judgment to reach a resolution.
Solution-driven approach.
Very good knowledge of regulatory requirements, including Good Clinical Practice and ICH guidelines.
Ability to travel 10% as required.

Responsibilities

Oversee all aspects of project conduct from start-up through close-out.
Execute operational aspects of assigned project activities and special projects.
Manage projects according to the scope of work and contracted budget; manage project revenue and invoicing.
Ensure projects follow UBC SOPs and applicable client SOPs.
Develop project plans and processes to achieve contracted milestones, monitor progress, and ensure compliance with plans.
Prepare project timelines and prepare or coordinate development of deliverables.
Prepare meeting agendas and create meeting minutes and action logs.
Track project budgets against contract milestones.
Serve as UBC’s primary contact with the sponsor and coordinate project meetings with internal and external stakeholders.
Act as a focal point for project team member questions.
Lead projects with cross-functional involvement and supervise the functional areas that support them.
Ensure project training occurs and assist with training as assigned.
Develop content for and lead internal and external kickoff meetings.
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 in audit-ready condition and participate in sponsor or regulatory audits as required.
Coordinate investigator meetings as required.
Assist with protocol development and/or patient or subject consent forms, REMS, and REMS Supporting Documents as required.
Help lead process improvement activities.
Establish, implement, and track key metrics to report project and initiative progress.
Coordinate and ensure maintenance of the Trial Master File as required.
Perform CSS and CRA duties as needed.
Perform other duties as assigned by management.
Supervise the project team.