Regional Clinical Operations Lead

Conteúdo do emprego

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.
• Knowledge using computer applications including spreadsheets, MS Project, email, word-processing software and web-based systems.
• 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).
  

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Jack O’Neill on +44 203 846 0604.

A Full Job Description Is Available On Request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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