Study Manager

vor 1 Woche

Home Office, Schweiz Luzsana Biotechnology (Part of Hengrui) Vollzeit

**Company**: Luzsana Biotechnology (Part of Hengrui)

**Job Title**: Sr. Study Manager Europe

**Department**: Clinical Operations

**Location**: Basel, Poland, Netherlands OR Spain

**About Hengrui**:
Luzsana Biotechnology (Luzsana), is a global, purpose-driven innovative medicines company committed to delivering medicines that are available, accessible and affordable to more people around the world. Luzsana, a wholly owned subsidiary of Hengrui Pharma, is a global development and commercialization biotechnology organization. Luzsana has developed a strategic plan with Hengrui Pharma that provides the company access to a world-class pipeline of more than 250 clinical studies in areas of high unmet medical need, such as oncology, cardiovascular, metabolic/diabetes, pain management, immunology and liver and renal disease.

**Job Summary**:
The Study Manager/Senior Study Manager is responsible for execution and delivery of assigned studies across Europe to time, budget and quality as defined in protocol as well as in European regulations, ICH GCP/IND guidelines and the internal company’s procedures. The Study Manager/ Senior Study Manager is responsible for matrix leadership and project management including oversight of the countries management and monitoring activities across Europe. The Study Manager/ Senior Study Manager is a point of contact for Global Study Team, European Team, Medical Advisors, CRAs, sCRAs, Start
- up Specialist and other Staff aligned to the studies. They possess a high level of clinical expertise and is involved in the mentoring and training of European staff and sharing best practices across region. They are a crucial link between the regional, local and global teams and external stakeholders based in many countries in Europe.

Tasks

**Essential Job Functions**:

- Risk-based planning, organizing, and managing for each stage of the study.
- Conduct clinical study start-up activities and lead countries/sites feasibility, enrollment projections and site activation activities in cooperation with Medical Advisors, Start-Up Manager, and Regional Management. Oversee the site qualification process.
- Contribute in the development of the core study documents, plans, and processes and in the preparation of the study protocol operational elements.
- Develop, drive, and maintain regional study plan and forecast, incl. management of budgets, milestones, timelines, quality, and risk mitigation.
- Oversee study approval processes for Health Authority, IEC approvals and provide input for all study documents as required
- Responsible for overseeing study start-up activities and coordinate functional groups to ensure sites are initiated per study plan.
- Oversee forecasting of regional need for IMP and study supplies
- Ensure study-specific training to relevant regional team members
- Plan, organize, and lead relevant meetings, e.g., regional kick-off meeting, Investigator Meeting, CRA Meeting ; and provide training on operational and study-specific aspects during those meetings
- Responsible for ensuring that vendors provide timely input and generate documents in a timely manner and with quality
- Review and approve monitoring visit reports within agreed timelines, focusing on any trends or issues.
- Oversee regional recruitment at the study and site level, incl. forecasting, set-up contingency plans to ensure a enrollment target is achieved.
- Coordinate internal and external operational activities, maintaining oversight on investigator sites’ progress, gaps, issues, and review of protocol deviations and metrics.
- Responsible for oversight of Trial Master File with periodic audits by ensuring proper study documentation is maintained and archived in the TMF.
- Coordinate pre-audit and CAPA resolution activities ensuring satisfactory outcome, if any
- Lead and provide direction to the regional cross-functional team to ensure the delivery execution of the assigned clinical studies on time, within budget, and with high quality from the study start up to the clinical study report in adherence to company policies, internal SOPs, GCP requirements, and applicable regulations in any operating model (hybrid model, in-house model, outsourced model)
- Act as key contact person in Europe for regional, local, and global teams and external stakeholders.
- Disseminate relevant information to internal and external team members in effective and timely manner
- Provide regular study status updates including key performance indicators, deviation to timelines, critical study issues incl. follow-up, risk mitigation actions to Director Clinical Operations and Senior Management as needed.
- Ensure quality and integrity of clinical studies conducted in European countries by taking appropriate operational management activities as agreed with Director Clinical Operations, Senior Management and Quality Management.
- Identify gaps and issues in the clinical and company internal processes.
- Knowledge of and adherence to

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