Sr. Study Manager Europe

Vor 2 Tagen

Basel, Schweiz Hengrui USA Vollzeit

**Company: HENGRUI EUROPE THERAPEUTICS**
**Job Title: Sr. Study Manager Europe**
**Department: Clinical Operations**
**Location: Basel, Poland, Netherlands OR Spain**

**About Hengrui**:
The Hengrui ex-China organization drives the development and commercialization of the Hengrui innovative medicines portfolio for the US, Europe and Japan. Our ex-China team drives strategy and operational implementation for clinical development, regulatory approval and commercial success.

Our parent company Jiangsu Hengrui Medicine (600276 SHA) is a global pharmaceutical company with around $90 Billion market value, $3.6 Billion annual revenue (data by 2019) and over 30,000 employees globally. Our pipeline opportunities include antineoplastic, metabolic, cardiac, surgical, contrast agents, anti-virals, and antibiotics. The therapeutic areas are diverse, covering oncology, autoimmune, pain management, neuroscience, metabolics, etc.
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 ex-China 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.

**Job Requirements**:
**Experience/Education**
- Advanced degree (e.g. MS, PhD, MD, PharmD) in a field of Life Science, Medicine, Clinical Research, Pharmacy.
- A minimum 7+ years of clinical research experience, in planning/executing and monitoring clinical trials.
- At least 4 years of experience in a regional/global project management role.
- Experience in oncology is preferred.
- Personal management and leadership experience preferred.

**Knowledge / Skills / Abilities**:

- Excellent understanding and knowledge of clinical research, drug development, clinical study management, and the associated regulatory processes, quality requirements and international regulations (ICH-GCP, European Regulations, SOPs).
- Strong project management mindset, and ability to work and lead in a matrix team environment involving both internal and external Partners.
- Strong skills and experience in project management (including scope, budget, timeline, people management, and use of associated tools and support)
- Excellent organizational skills, with ability to prioritize and work effectively in a complex matrix environment
- Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
- Excellent interpersonal, oral, written communication skills
- Strong presentation skills
- Effectiveness at problem solving and conflict resolution
- Advanced level of English (written &verbal communication skills)
- Advanced level of Microsoft Office (PowerPoint, Excel, Word & Outlook)

**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 meeting

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