About this role
TFS HealthScience is a leading global midsize 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 CROs 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
Experience in Clinical Research in the Pharmaceutical Industry
We provide a competitive compensation package comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. Youll 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 wellbeing 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