Interim Medical Monitor / Study Physician (gn)

80-100% capacity, full remote work

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 a strong emphasis on team effort.

 

To support their Clinical R&D Team we are looking as soon as possible for a

Interim Medical Monitor / Study Physician (gn)

80-100% capacity, full remote work

  • Bereich:

    Medical

  • Berufssparte:

    Forschung/Entwicklung

  • Arbeitsregion:

    Home Office (remote)

  • Art der Anstellung:

    interim

  • Kennziffer:

    26574

  • Aktualisierung:

    2021-05-04

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Your responsibilities

Professional activites:

  • Co-design of the clinical development plan and study design, ensuring medical feasibility
  • Writing of study plans, study amendments, study reports and scientific publications
  • Collaborate on multidisciplinary study teams in the execution of clinical trials
  • Assisting in the submission of study documents and conducting scientific discussions with regulatory authorities
  • Statistical as well as medical interpretation of collected study data in terms of study evaluation
  • Continuous medical-scientific review of accruing study data as well as continuous review of drug safety during the course of the study
  • Establishment and maintenance of external study committees (IDMCs, Study Steering Committees)
  • Internal and external presentation of scientific findings and study results
  • Interact with Program Director on selected activities requiring coordination of physicians and/or external CROs
  • Compliance with national and international scientific and regulatory guidelines, laws, GCP regulations, internal rules and procedures

 

Additional professional activities (advisory, supervisory or representative function for non-medical colleagues (COPM, CRA))

  • The medical activity includes that the Medical Monitor (physician) has the medical supervision of the studies entrusted to him/her and contributes to the medical risk-benefit assessment in the clinical study
  • The Medical Monitor (physician) is the primary contact person for all staff in other departments who need advice on medical issues and for all study teams to resolve medical questions and problems
  • Advise on ensuring medically appropriate recruitment and care of study participants in the respective studies; advise on conducting appropriate checks and evaluations of patient records and documentation
  • Medical reference regarding pathophysiology, diagnosis and therapy in the indication area within the team internally and during technical discussions with clinical trial investigators
  • Discussion of medical issues and review of individual cases with pharmacovigilance
  • Review and assessment of:
    • Study plans with regard to medical aspects (health care systems, diagnostic criteria, guideline based therapy, administration of possible safety risks for study patients, radiation protection, if applicable, feasibility, statistics)
    • Ethical principles of medical practice
    • Epidemiological conditions in the planned countries
  • Ensuring constant updating of scientific and technical knowledge of the study team

Your qualification

  • Degree in medicine
  • Focus on rheumatology, neurology, immunology or autoimmune diseases
  • Experienced in the biotech or pharma industry
  • Highly effective verbal and written communication and presentation skills in English

Your contact person

Jan Büscher
Geschäftsführer

Address

Optares ICM GmbH & Co. KG
Jan Büscher
Heiligengeist Höfe 8
26121 Oldenburg