About this role TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing and Functional Service (FSP) solutions. As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical/biotech company that is an industry leader Key Responsibilities • Medical responsible for assigned projects • Maintains clinical oversight and quality on their trials and deliver according to study targets • Specific medical/safety monitoring activities, ensuring compliance with ethical, legal, and regulatory standards • Conduct clinical trials according to ICH GCP, local regulations, study protocol and company PNTs. • Comply with environment, safety and health regulations. • Maintain strict confidentiality on all information provided work with agreed clinical development plans • Work closely with colleagues within R&D and innovation Department, and other areas if required by the specific assigned projects • Write protocol, and review CRDs, medical monitoring plan, Safety plan and other documents related with the medical responsibilities of the clinical trial • Write and review Informed consent documentation • Write and review Clinical study reports, Investigational brochures and other documents related with the clinical research. • Create presentations for dissemination of the results and other tasks related with the finalization of the clinical trial • Medical monitoring of the trials • Oversee a lab report review, CRF safety review, and potential endpoint reporting, for clinical projects • Review medical listings and create queries • Provide medical responses to potential questions from the investigators, ERCs and HA. • Attendance to the CRO´s training, investigators meetings, blinded data review meeting, and other meetings related with their medical responsiblity of the clinical trial. • Review and follow Scientific Advice conclusions for applicable projects • Provide support in interactions with regulatory authorities regarding clinical trial protocol, protocol amendments, biefing package, and clinical part of registration dossiers. • Provide support in regulatory agency inspections and internal audits of assigned projects • Organise the drafting and revisions of posters and papers to disseminate the results from the clinical research activities • Actively contribute to reviewing and following Standard Operating Procedures and Working Instructions Qualifications • Degree in Medicine • Experience in Clinical Research in the Pharmaceutical Industry What We Offer: We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients A Bit More About Us: Our journey began over 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients' safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East. Our core values of Trust, Quality, Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization. #Together we make a difference #J-18808-Ljbffr
