Study Manager

Vor 3 Tagen

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

Luzsana Biotechnology (Luzsana) is a global, purpose-driven innovative medicines company with the mission to deliver medicines that are available, accessible, and affordable to anyone, anywhere. The origin of the Luzsana name is rooted in “la luz,” which is Spanish for the light, and “sana,” which is Latin for heal.

Luzsana is a healthcare company that aspires to become a “healing light” across the biotech sector by prioritizing the well-being of all stakeholders it encounters while operating its business. Through a strategic plan with its parent company Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma), Luzsana co-develops innovative medicines in areas of high unmet medical need for commercialization in North America, Europe, and Japan.

The company’s pipeline currently includes 11 high-potential oncology and non-oncology programs that span all stages of development from preclinical to phase 3, which it intends to further diversify over time. These programs aim to address areas of high unmet medical need, some with first-in-class or best-in-class potential.

We recognize, appreciate, and reward our team’s contributions; we emphasize our people’s well-being. We want our employees to feel empowered to do their best work, to engage in shaping our growing organization and to be part of a team where they are respected, engaged, fulfilled, and developing

**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 conta

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