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 enhan…
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 enhanc…
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 enhanc…
Skills: Benefit Investigations, Insurance Verification, Prior Authorizations, Data Entry, Customer Service
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 enhanc…
Skills: Case Management, Prior Authorization, Pharmacy Benefit Management, Medical Claims Processing, Microsoft Office
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 enhanc…
Skills: Case Management, Prior Authorization, Pharmacy Benefit Management, Medical Claims Processing, Microsoft Office
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 enhanc…
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 enhanc…
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 enhanc…
Skills: Clinical Case Management, Prior Authorization, Medical Record Review, Patient Access, Reimbursement
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 enhanc…
Skills: Clinical Case Management, Patient Access, Prior Authorization, Medical Record Review, Reimbursement Troubleshooting
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Full-time
bachelor degree, postgraduate degree
Posted 25d ago
~40 hrs/week
Remote in Spain, United Kingdom
Responsibilities
The Senior Clinical Project Manager provides operational oversight for European and global projects, ensuring delivery of contracted services within budget and timelines. This role involves leading cross-functional teams and serving as the primary point of contact for sponsors throughout the study lifecycle.
Requirements
Candidates need a Bachelor's degree in a scientific field and either 2-3 years of CRO project management experience or 5+ years of clinical trial experience. Proficiency in GCP, ICH guidelines, and project management software is essential.
Full job description
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 inclusiveworkplace 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
United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. Underpinned by our scientific expertise, data and analytics, and innovative technologies, we offer our customers flexible solutions generating the relevant real-world data necessary to make more informed decisions earlier, meet stakeholder requirements, and ultimately, drive better patient outcomes.
Offices: 1000 Continental Dr, Suite 600, King of Prussia, Pennsylvania 19406, US · Charter Place, Charter Building, 4th Floor, Uxbridge, England UB8 1JG, GB · 16 Chemin des Coquelicots, Vernier, Geneva, 1214, CH · 680 Century Pt, Lake Mary, Florida 32746, US · 935 Canyon Rd, Morgantown, West Virginia 26508, US
United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. Underpinned by our scientific expertise, data and analytics, and innovative technologies, we offer our customers flexible solutions generating the relevant real-world data necessary to make more informed decisions earlier, meet stakeholder requirements, and ultimately, drive better patient outcomes.
Offices: 1000 Continental Dr, Suite 600, King of Prussia, Pennsylvania 19406, US · Charter Place, Charter Building, 4th Floor, Uxbridge, England UB8 1JG, GB · 16 Chemin des Coquelicots, Vernier, Geneva, 1214, CH · 680 Century Pt, Lake Mary, Florida 32746, US · 935 Canyon Rd, Morgantown, West Virginia 26508, US