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hace 2 meses

Sant Feliu de Llobregat, España Almirall A tiempo completo

Date: Jan 24, 2023- City: SFEL - R&D SANT FELIU DE LLOBR**Mission**:
To develop, implement and manage assigned clinical trials of Almirall own research and under license products. Collaborates with the Global Clinical Leader on the required tasks of the clinical development of new medications

**Tasks and Responsibilities**:

- Responsible for planning and conduct of clinical trials from Phase I to Phase IV, including preparation, review or approval of all associated documentation (protocol, report, timelines, all study plans communication, vendors, monitoring, safety, statistical, data management, technical specifications, IMP related documents, and any other study-related documentation) and management of study budget, including approval of invoices payment and forecast planning.
- Leading CRO and other vendors selection for the outsourcing of Clinical Trials and other activities task according to Project needs.
- Leadership and coordination of the different areas and activities of the “Clinical Study Team”(CST).
- Cooperation with other department representatives when needed, among others, Project Management, Regulatory Affairs, Corporate Global Drug Safety, Pharmacokinetics and Metabolism, Intellectual Property, Quality Assurance, Skin Biology, Global Clinical Leader, Global Medical Affairs, Marketing, R&D Procurement and R&D Finance.
- Participate in the preparation of any documentation related to competent national and local authorities, and the relevant ethics committees, coordinate and boost regulatory submissions and answer to their questions.
- Organize and/or participate in the Investigators Meeting/Kick-off Meetings presenting the protocol and study operational aspects (study drug, monitoring) of the study, and visit research sites ad-hoc
- Supervise and boost sites activation and recruitment progress, database cleaning, and timely SAE reporting. Review of the Trial Master File key documents related to activities under ICTM direct responsibility.
- Collaboration in the planning and conduction of audits and CAPA implementation, and in the inspections to the participating sites or sponsor.
- Ongoing review of clinical blinded data (e.g. for identification of protocol deviations, ensuring accuracy of data cleaning, early detection of unexpected trends on patients baseline characteristics).
- Ensuring the clinical trials are conducted in accordance with Good Clinical Practices (GCPs), with applicable international quality standards, with the agreed (CRO/Almirall) SOPs, policies and standards, as well as any other guidelines given by the Head of Global Clinical Operations (GCO) and GCL/GMA.

**Education**:

- Graduate in Health Sciences (Pharmacy, Biology, Biochemistry and/or Medicine and Surgery).
- Master’s in clinical trials or specific courses about the Scientific Methodology of the CCTT and GCPs.
- PhD in scientific field desirable.
- Courses about general and/or special aspects of the Pharmaceutical Industry

**Specific Knowledge**:

- At least 6 years of experience managing Clinical Trials internationally
- Experience in Dermatology desirable
- Basic Statistics and/or Biometry knowledge
- Project Management
- Basic Pharmacokinetics, Clinical Toxicology and Pharmacology
- Proficiency in English

**Values and competencies**:

- Internal and External Stakeholders management
- Communication and Influencing
- Driving results
- Preassure Management
- Analysis and Problem Solving

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