Recherche Clinique à États-Unis

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.

• 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

• 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 initiatives
• Prepare and participate in presentations to clients in defence of proposals
• Present project information at bid defences, client meetings and UBC internal project governance and review meetings
• Other duties as assigned by management

• Minimum a Bachelor’s degree or equivalent in a clinical, scientific, or related field, with an advanced degree desirable, or sufficient, relevant job experience, or another relevant education
• 2 to 3 years direct project management experience at a Contract Research Organisation (CRO) or 5 or more years of clinical trial experience
• Has proven working experience and understanding of working within clinical research
• Knowledge of the key principles of cross functional project management

• Proficient in use of web based IT systems (e.g. CTMS or electronic Case Report Forms) and Microsoft (MS) Excel, MS PowerPoint, and MS Word
• Experience using project management software (e.g. MS Project)
• Ability to effectively use automated systems and computerized applications
• Very good knowledge of regulatory requirements for research conduct (i.e. Good Clinical Practice, International Conference on Harmonization (ICH) guidelines, etc.)
• Excellent working knowledge of clinical research / development, including medical and therapeutic areas, phases and medical terminology
• Knowledge of CRO / Pharmaceutical functional departments and responsibilities
• Good quantitative skills and working understanding of project budgets (solid financial acumen)
• Proficient in local language (oral and written) and profound working knowledge of the English language (oral and written)

• Excellent communication skills and ability to communicate effectively with all levels of an organization
• Excellent interpersonal, verbal and written communication skills
• Able to lead, motivate and coordinate teams
• Excellent planning and problem solving skills
• Able to delegate, effectively prioritizes own and workload of project team members
• Flexible and adaptable to changing situations
• Very good supervisory skills
• Very good presentation skills
• Excellent organisational and time management skills
• Proficient at multi-tasking with good attention to detail
• Has experience with leading, liaising and coordinating cross-functional project teams
• 10% travel