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Medical Monitor / Study Physician (m/f/d) (DE)

[5189]

Our client is a NASDAQ listed biotechnology company with the global Headquarter in Germany. The companies focus is the research and development of new medicines for the treatment of inflammatory diseases within a global development approach. Our client stands out for an excellent team of highly motivated and skilled individuals who put strong emphasis on a team effort To support our Clinical Research & Development team we are looking for a Clinical Programm Manager (m/f/d) Your tasks  ·Co-designing the clinical development plan and the study design, ensuring medical feasibility ·Writing of study protocols, protocol amendments, study reports and scientific publications ·Cooperating in multidisciplinary study teams in the execution of clinical studies ·Supporting the submission of study documents and conducting scientific discussions with authorities ·Statistical and medical interpretation of collected study data in terms of study evaluation ·Continuous medical-scientific review of study data and continuous monitoring of drug safety during the course of the study ·Set-up and maintenance of external study committees (IDMCs, Study Steering Committees) ·Internal and external presentation of scientific findings and study results ·lnteracting with the Program Director in selected activities that require the coordination of investigators or external CROs ·Compliance with national and international scientific and regulatory guidelines, laws, GCP regulations, internal rules and procedures ·Medical supervision of clinical studies and contribution to the medical risk-benefit assessment in clinical trials ·Primary contact person for staff members in other units for advising on medical questions and for all study teams for resolving medical questions and issues ·Advice on ensuring the medically proper recruitment and car of study participants in the respective clinical studies ·Advice on carrying out appropriate checks and evaluations of patient records and patient documentation ·Medical reference regarding pathophysiology, diagnosis and therapy in the respective indication area for the team internally and in expert discussions with clinical investigators ·Discussions of medical issues and assessment of individual cases with Pharmacovigilance ·Review and assessment of study protocols regarding medical aspects (health care systems, diagnostic criteria, guideline-compliant therapy, administration of possible safety risks for study patients, radiation protection, if applicable, feasibility, statistics) ·Review and assessment of ethical principles of medical action ·Review and assessment of epidemiological conditions in the respective countries ·Ensuring the continuous update of the study team’s scientific-technical knowledge Your qualifications ·MD degree in the relevant scientific field (e.g. pharmacology, immunology, molecular biology) or veterinary ·Professional Clinical R&D experience: 5+ years with phase 1 - phase 3 studies as Medical Monitor, Study Physician or another role with similar responsibilities ·Experience in working in multinational cross-functional teams ·Effective communication and presentation skills ·Fluent in written and verbal English ·Highly motivated, pro-active and self-driven attitude If you feel attracted by this job feel free to get in touch with Tilman Grumbd, Managing Partner at Optares Medical via tilman.grumbd@optares.de or by phone under 0049 441 218 7934

Our client is a NASDAQ listed biotechnology company with the global Headquarter in Germany. The companies focus is the research and development of new medicines for the treatment of inflammatory diseases within a global development approach. Our client stands out for an excellent team of highly motivated and skilled individuals who put strong emphasis on a team effort


To support our Clinical Research & Development team we are looking for a


Clinical Programm Manager (m/f/d)


Your tasks 

  • Co-designing the clinical development plan and the study design, ensuring medical feasibility
  • Writing of study protocols, protocol amendments, study reports and scientific publications
  • Cooperating in multidisciplinary study teams in the execution of clinical studies
  • Supporting the submission of study documents and conducting scientific discussions with authorities
  • Statistical and medical interpretation of collected study data in terms of study evaluation
  • Continuous medical-scientific review of study data and continuous monitoring of drug safety during the course of the study
  • Set-up and maintenance of external study committees (IDMCs, Study Steering Committees)
  • Internal and external presentation of scientific findings and study results
  • lnteracting with the Program Director in selected activities that require the coordination of investigators or external CROs
  • Compliance with national and international scientific and regulatory guidelines, laws, GCP regulations, internal rules and procedures
  • Medical supervision of clinical studies and contribution to the medical risk-benefit assessment in clinical trials
  • Primary contact person for staff members in other units for advising on medical questions and for all study teams for resolving medical questions and issues
  • Advice on ensuring the medically proper recruitment and car of study participants in the respective clinical studies
  • Advice on carrying out appropriate checks and evaluations of patient records and patient documentation
  • Medical reference regarding pathophysiology, diagnosis and therapy in the respective indication area for the team internally and in expert discussions with clinical investigators
  • Discussions of medical issues and assessment of individual cases with Pharmacovigilance
  • Review and assessment of study protocols regarding medical aspects (health care systems, diagnostic criteria, guideline-compliant therapy, administration of possible safety risks for study patients, radiation protection, if applicable, feasibility, statistics)
  • Review and assessment of ethical principles of medical action
  • Review and assessment of epidemiological conditions in the respective countries
  • Ensuring the continuous update of the study team’s scientific-technical knowledge

Your qualifications

  • MD degree in the relevant scientific field (e.g. pharmacology, immunology, molecular biology) or veterinary
  • Professional Clinical R&D experience: 5+ years with phase 1 - phase 3 studies as Medical Monitor, Study Physician or another role with similar responsibilities
  • Experience in working in multinational cross-functional teams
  • Effective communication and presentation skills
  • Fluent in written and verbal English
  • Highly motivated, pro-active and self-driven attitude

If you feel attracted by this job feel free to get in touch with Tilman Grumbd, Managing Partner at Optares Medical via tilman.grumbd@optares.de or by phone under 0049 441 218 7934

map München oder Jena date_range 10.11.2021 update Permanent
Medical Medical Monitor Clinical Research


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