Company in the Medical sector. Working with program leadership and team members to further clinical development program by assisting in the design and conduct of clinical trials including the drafting of protocols and amendments and contributing to related clinical documents. Be the Medical Expert (??Medical Monitor?) for assigned clinical trials which includes being readily available to advise on trial-related medical questions or problems during the conduct of the trial. Lead medical aspects of medical monitoring, including CRO oversight for medical monitoring activities as needed.Identifies study challenges during the conduct of the study and works with relevant stakeholders to ascertain and implement solutions.Contribute to investigator training. Contribute to responses regarding IRB/ethics committee queries.Assist in medical data review, assessment and interpretation of clinical and safety data to ensure that the data are correct and presented with the appropriate medical interpretation. Medical degree with strong leadership skills including 5-10 years direct experience in the pharmaceutical industry preferably in a medical monitoring role. US and EU experience preferred. Experience in IBD preferred but all therapeutic areas will be considered. Understanding of local and global drug safety regulations and processes and clinical trial oversight, including global GCPs. Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders. GI experience in IBD, Crohn's Disease and/or Ulcerative Colitis strongly preferred as is experience in oversight of CRO for medical monitoring activities.
Associated topics: emergency department, emergency medical technician, emt i, emt p, lpct, pmt, technician, technician ii, technician basic, transport