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) 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