Sr Clinical Project Manager

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 Collaboration, Compassion, Curiosity, Consultative and Conscientious. 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 is looking for a talented professional to join our global team in either a Senior Clinical Project Manager or Clinical Project Manager capacity.

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 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

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