Senior Clinical Project Manager - Europe

Senior Clinical Project Manager - Europe

International Research & Clinical DE

3 days ago Requisition

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 of Respect, Accountability, Innovation, Quality, Integrity, and Collaboration. 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
!

UBC are currently recruiting within our Project Management team, we are looking to recruit a SR CPM with emphasis on Late Phase PM experience

Brief

Description:

The EU PM is responsible for providing operational oversight of assigned UBC projects. The EU PM will have a leading role in planning, coordinating and completing project work. The EU PM will work closely with external clients/sponsors, internal project team members, vendors, and suppliers to ensure satisfactory delivery of contracted services and achievement of contracted milestones for assigned projects. The EU PM will ensure that projects are conducted in a timely manner to achieve project goals within defined budgets.

Supervisory Responsibilities:

• Supervision of project team
• Supervise project management staff in execution of assigned studies
• Ensure that the PAds, PAs, APMs, PMs, project team members understand the client needs once a project is awarded
• Serve as a resource and mentor to the PA/APM in the execution of their daily activities
• Proactively assist the PA/APM in anticipating and seeking resolutions to potential and actual project issues

Specific

Job Duties:

• Oversee the day-to-day management of European and/or multi-national global projects
• Manage project per the scope of work and within the contracted budget
• Oversee all aspects of project conduct from start-up through close-out
• Prepare project timelines and prepare or coordinate project development of deliverables
• Ensure project is conducted according to UBC and client SOPs
• Ensure conduct of project related training and record keeping
• Serve as the UBC primary contact with the sponsor for all project related items
• Coordinate project meetings including investigator meetings and client meetings
• Lead internal and external project meetings
• Ensure project budget is tracked against contract milestones
• Manage project budget and resource expenditures including invoicing, analyzing cost variances, out-of-scope management, and conducting revenue recognition.
• Develop project plans to achieve contracted milestones (i.e. project plan, risk management plan, site management & monitoring plan, training plan, communication plan, etc.)
• Monitor project progress against the established plans and ensure compliance with plans
• Supervise and provide direction to assigned project team members including PAs, APMs, Clinical Research Associates (CRAs), Clinical Site Specialists (CSS), Regulatory Associates (RA)
• Focal point for resolving project team member questions
• Prepare and negotiate investigator/site/vendor budgets and assist with remediation of contract language
• Provide operational input and participate in the design and review of study protocols, case report forms (CRFs), study reports, and other functional documents and plans in collaboration with project team
• Coordinate development of patient/subject consent forms and site/patient materials
• Ensure Trial Master File (TMF/eTMF) is maintained and audit-ready on ongoing basis
• Monitor and ensure project team compliance with maintenance of Clinical Trial Management System (CTMS)
• Completion of departmental oversight trackers for projects (e.g. functional resource forms, project review form, project execution checklist)
• May be asked to perform Lead CRA or CRA duties on projects as needed
• Participate in internal UBC process improvement…