Senior Clinical Project Manager

3 giorni fa


Roma, Italia UBC A tempo pieno

Senior Clinical Project Manager - Europe
UBC is a pharmaceutical support industry leader 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 encourages creativity.
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 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

Education/Experience

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

Technical/Knowledge

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)

Attributes

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

Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Project Management and Information Technology
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