Clinical Project Manager - Home Based in Europe
- Experience Level
- Experienced (non-manager)
This position is available office based in London, or home based in UK, France, Germany, Italy, Spain, the Netherlands and Norway.
The Project Manager is responsible for providing operational oversight of assigned UBC projects, with a leading role in planning, coordinating and completing project work. The Project Manager will work closely with external clients/sponsors, internal project team members, vendors, and suppliers to ensure achievement of assigned projects.
Specific Job Duties:
- Ensure that projects are conducted in a timely manner to achieve project goals within defined budgets
- Oversee the day-to-day management of European and/or multi-national global projects
- Develop project plans to achieve contracted milestones (i.e. project plan, risk management plan, site management & monitoring plan, training plan, communication plan, etc.)
- Serve as the UBC primary contact with the sponsor and team members for all project related items
- Present project information at bid defenses, client meetings and UBC internal project governance and review meetings
- Provide input into client proposals in response to Requests for Proposals (RFPs)
- Coordinate and lead project meetings including investigator and client meetings
- 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, CRFs, study reports, and other functional documents and plans in collaboration with project team
- Ensure Trial Master File is maintained and audit-ready on ongoing basis
- Monitor and ensure project team compliance with maintenance of Clinical Trial Management System
- 10% travel
- Supervision of project team and mentor junior staff
- Ensure that the project team members understand the client needs once a project is awarded
Desired Skills and Qualifications:
- Bachelor’s degree or equivalent in a clinical, scientific, or related field, or relevant job experience
- 2 to 3 years direct project management experience at a CRO, or 5 years of clinical trial experience
- 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)
- Experience with leading, liaising and coordinating cross-functional project teams
- Very good knowledge of regulatory requirements for research conduct (i.e. GCP, ICH, etc.)
- Excellent working knowledge of clinical research/development, including medical and therapeutic areas, phases and medical terminology
- Good quantitative skills and working understanding of project budgets (solid financial acumen)
- Excellent communication skills, with proficiency in local language and English
- Excellent planning and problem solving skills, flexible and adaptable to changing situations
United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.
While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.
Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
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