Medical Monitor - MD - Director
Edison-New Brunswick Metro Area, NJ
US and EU experience preferred.
Experience in IBD preferred but all therapeutic areas will be considered. GI experience in IBD, Crohn's Disease and/or Ulcerative Colitis strongly preferred as is experience in oversight of CRO for medical monitoring activities.
Understanding of local and global drug safety regulations and processes and clinical trial oversight, including global GCPs.
Oversight of 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.
Work closely with the other departments providing medical input into safety reports including, SAE narratives and analysis of similar events, Development Safety Update Reports (DSURs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) reports, Company Core Safety Information (CCSI), Investigator Brochure (IB), Risk Management Plans, Integrated Summaries of Safety and Efficacy, Clinical Study Reports and preparation of labels.
Collaborate with safety/pharmacovigilance to implement the safety monitoring plan