Regional Clinical Operations Lead
vor 19 Stunden
Proclinical are proud to announce our exclusive partnership with Ultragenyx Pharmaceuticals in support of their ongoing European expansion.
Ultragenyx are a US based biotech committed to the development of innovative therapies for patients with serious rare and ultra-rare genetic diseases. Their unique approach has led to the successful development of multiple first-ever disease treatments at speeds faster than industry average.
As a result of the rapid expansion of their Biologic, mRNA and Gene-Therapy portfolios we are seeking a Regional Clinical Operations Lead who will play a key role in continued development and eventual commercialisation of their products. This role is on a permanent basis located in Basel, with flexibility to work from home.
**Responsibilities**:
- Effectually supervise the conduct of one or more trials, in one or more countries or region.
- Drive country/region study deliverables, project timelines and milestones, as well as quality and compliance of the study in alignment with the global plan.
- Enable strategic and tactical exchange of program, study, site level information and communication between UGX European community, including country affiliates, and Global Study Teams.
- Act as a Subject Matter Expert for policies and country/regional regulations and for Sponsor Inspections by Regulatory Agencies or during audits.
- Build and uphold effective relationships with investigator sites and internal/external stakeholder groups.
- Coordinate and execute planning, start-up, recruitment, maintenance and close-out activities at the study level across the assigned region/country.
- Act as a point of contact and demonstrate leadership in the resolution of high/critical regional/country study or site issues.
- Co-operate with CRO partners to proactively find solutions to meet any challenges to the study deliverables and project timeline milestones.
- Offer strategic regional/country input into and review of key study specific study documents and training materials.
- Recognise potential study sites in collaboration with the study team, local Medical Affairs, and CRO.
- Conduct feasibility assessment and make recommendations for site selection.
- Support site initiation and close-out visits at selected clinical sites.
- Achieve implementation of Monitoring Oversight Plan and conduct selected Monitoring Oversight Visits with CRAs.
- Examine site visit reports for quality and completeness.
- Support the Study Management Team in Sponsor and protocol level training in the country/region.
- Support maintenance of Trial Master File to ensure study is always inspection ready.
- Evaluate and view quality metrics and provide solutions for continuous improvement.
- Uphold a working knowledge of rare/ultrarare disease and protocols.
- Support risk and issue management at country/region level.
- Network with other CCOLs to standardize study conduct and clinical monitoring processes across studies and drive operational excellence.
- Participate in initiatives and/or special projects, as assigned.
- Contributes in the development, review and implementation of Standard Operating Procedures, Work Instructions, Guidance Documents.
- Might have the responsibility to mentor Clinical Operations staff (e.g., Study Engagement Leads).
- May serve as a people leader of one or more direct reports within a matrix environment, including, performance management, oversight and development plan.
**Skills & Requirements**:
- A Bachelor's degree or similar is required (scientific or healthcare discipline is highly preferred).
- At least 12 plus years of extensive site management experience and monitoring experience across various disease areas and previous experience managing day-to-day operations of clinical trials.
- Experience in Rare disease is desirable but not essential to the role.
- Knowledge with partnering and managing CRO relationships.
- Compacted knowledge of clinical development processes with strong emphasis on monitoring.
- Excellent ability to manage and collaborate on complex protocols within a matrix environment.
- Proficient knowledge of ICH Good Clinical Practice guidelines.
- Excellent planning and organizational skills.
- Able to handle multiple tasks and deadlines.
- Self-motivating attitude and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors.
- Highly effective verbal and written communication skills.
- Flexible and solution focused.
- Strong customer focus.
- Must have the ability to build and maintain positive relationships with clinical sites, peers and management.
Outstanding written and verbal skills in French and English or German/English, additional languages are advantageous.
- At least some travel up to 25% and dependent on need will be required post-COVID (regional, international).
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment b
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