Berlin, Berlin, Germany
To support safety of all subjects enrolled into clinical trials. To review study protocols/synopses/concept sheets with respect to feasibility and medical safety. To perform a formal risk assessment of each clinical trial for risk mitigation purposes based on the study protocol, the Investigator’s Brochure and other documents relevant from medical safety perspective. To provide study specific training from medical safety perspective to the clinical staff involved in the conduct of the clinical trial. To support investigators involved in the conduct of clinical trials with safety reporting and pharmacovigilance. To interact with relevant pharmacovigilance facilities for clarification safety reporting issues. To interact with sponsors’ medical representatives for clarification of medical safety aspects. To support investigators with assessment of relevant eligibility criteria and screening results for subjects planned to be enrolled into clinical studies. To support investigators with continuous review of safety results for subjects enrolled into clinical trials. To support investigators with assessment of abnormal safety results. To provide guidance on medical and scientific aspects. To provide answers to any study related and/or general medical questions raised by any members of the projet team. To support quality assurance by ensuring that medical safety related activities and conditions are conform to SOPs and associated documents. To support quality assurance by ensuring that SOPs and associated documents reflect the needs in performing clinical trials. To support the Medical Writer in generating any study document. To support project management with generating study specific safety management plans. To support business development activities. To collaborate with Delivery owners and project teams in assessment of staff performance. To provide medical line management.
General internal medicine - esp. gastroenterology - incl. GI/abdominal oncology and - interventional endoscopy - Hepatology - Infectious diseases - Rheumatology - Nutritional medicine