Senior Clinical project manager (Based in Barcelona - single sponsor)

Description

TFS HealthScience is a Global CRO headquartered in Sweden. We genuinely believe that "Global in mind and local at heart" is the core of our success; we operate in a global environment while retaining an in-depth knowledge of regulatory requirements in every country where we operate. At TFS, you will be offered the possibility to develop in a global organization with a company culture distinguished by passion, innovation and talent.

Project related:

• Active participation in the preparation of Clinical Development plans
• Collaboration in the elaboration and review of clinical trials outlines, DSUR, IB, and international (Europe/FDA) submission dossiers.
• Participation and reporting to the Project Team (PT), Medical SubTeam (MST), Core Teams and, any other team as needed.
• Participation in advisors, partners or in- and out-licences meetings, including the preparation and review of associated documentation.
• Collaborate in the creation of presentations for congresses and/or papers for medical journals based on CT results.
• Planning and conduct of clinical trials/experimental and cosmetic testing/investigations with medical devices, including preparation, review or approval of all associated documentation (synopsis, protocol, report, timelines, all study plans -statistical, data management, monitoring,...-, technical specifications, IMP related documents, and any other study-related documentation) and management of study budget, including approval of invoices payment and forecast planning.
• 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), and organisation of periodic meetings.
• Cooperation with other department representatives when needed
• 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/Pre-initiation visits/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 CTM 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 CT blinded data (e.g. for identification of protocol deviations, ensuring accuracy of data cleaning, early detection of unexpected trends on patients baseline characteristics).
• Leadership of the “Blind Data Review Meeting”.
• Ensuring the CT 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.
• Report and discuss with the Medical subteam Escalation to the GCL and/or Project Manager and Head of GCO any significant deviation (or a risk for deviation).
• Continuing education and training on medical and clinical research topics. Assistance to courses, congresses, trainings, investigator’s meetings, specialised journals reading, international conferences, etc.
• Collaboration in SOPs update/creation/training.

Requirements

• Graduate in Health Sciences (Pharmacy, Biology, Biochemistry and/or Medicine and Surgery).
• Participation in Clinical Trials
• Pharmaceutical Industry business
• Project Management
• Basic Statistics and/or Biometry
• Basic Pharmacokinetics, Clinical Toxicology and Pharmacology
• Others: Preferably Doctor’s degree

• English essential
• Other languages desirable
• Communication and Negotiation skills
• Previous Experience in the role

Experience

Mid-Senior level

Fecha de publicación: 01/06/2022