REMS Project Manager

Brief Description :

Lead UBC project teams to deliver project milestones

Specific Job Duties :

• Serve as the primary contact with the sponsor for all study related items, with oversight of all aspects of project conduct, from study start-up through close-out in accordance with company and project specific SOPs, guidelines, budgets, timelines and contracts
• Execute operational aspects of assigned project activities as well as special projects
• Assist in the development and design of protocols, CRFs, regulatory documents, project master file, and other project related deliverables
• Ensure operational plans are developed consistent with project needs, including but not limited to, the development of communication plans, monitoring plans, project plans, training plan, study timelines, Compliance Plan and clinical management plans; monitor project progress as compared to established plans and ensure compliance with plans
• Facilitate and plan investigator meetings; recruit qualified investigators and assist in budget negotiations as required
• Supervise APM / PMs and other team members to ensure project deliverables and timelines are delivered accurately and timely; provide reports to the Sponsor on project progress
• Lead projects with cross functional involvement and supervise all functional areas that support the project
• Assist in revenue and invoicing for project(s)
• Supervise all functional areas that support the project
• Ensure project training occurs and assist with training for project, as assigned
• Serve as a resource to team members for all inquiries and issue resolution for site management, contract budget and remediation, and regulatory document preparation
• Lead internal client teleconferences and / or meetings and present project information at client meetings, bid defenses and UBC monthly project review meetings
• Maintain project documentation to be “audit ready”
• Support APM / PMs in sponsor / regulatory audits as required
• Assist in preparation of client proposals in response to RFPs
• Ensure project budget is tracked against contract milestones
• May be asked to assist in protocol development and / or patient / subject consent form or REMS and REMS Supporting Documents as required
• Initiate and lead process improvement activities
• Accurate reporting and interpretation of project metrics
• Proposal and implementation of action plans
• Satisfactory delivery of contracted services and achievement of contracted milestones for assigned projects
• Duties described for Project Manager and other duties as assigned by management

Supervisory Responsibilities :

Desired Skills and Qualifications :

Expected Project Load :

2 to 3 projects depending on scope

Benefits :

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 :