International Clinical Trial Manager 1

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).
Masters 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
Competences
Internal and External Stakeholders management
Communication and Influencing
Driving results
Preassure Management
Analysis and Problem Solving
Almirall

Fecha de publicación: 15/03/2023