Study Physician / Medical Monitor at KPS Life

The primary responsibility of the Study Physician/Medical Monitor is:

• To be responsible for overall study deliverables from medical perspective.
• To provide medical expertise to ensure effective and efficient delivery of all medical aspects of the assigned study (or studies) through all stages of planning, start-up, conduct, and close-out, in accordance with the appropriate quality standards including ICH/GCP, Sponsor Global SOPs, and applicable local regulations.

The Study Physician/Medical Monitor will:

• Maintain up-to-date knowledge of clinical principles assigned therapeutic areas
• Identify and interact with potential investigators in the field
• Provide medical input to protocol synopsis, protocol of clinical studies and project strategy (e.g. CDP/TPP)
• Provide medical input into data preparation, analysis, report writing, and other study documents (e.g. CRF, ICF, IB, SAP, DSUR and TMF)
• Maintain oversight of CRO medical monitoring of clinical studies
• Conduct medical reviews of clinical / safety data from ongoing trials
• Prepare and review documents for regulatory agencies, if applicable
• Participate in communications with patient advocacy groups
• Provide training in relevant therapeutic areas and study activities (including TCRD internal training and external meetings such as investigator meetings)

The Study Physician/Medical Monitor will have:

• Knowledge of statistical analysis and clinical pharmacology
• Knowledge of ICH-GCP guidelines, and international regulatory requirements, if applicable
• Knowledgeable about the clinical trial processes
• Knowledge of pharmaceutical, biotechnology, biomedical, and/or clinical research industry
• Excellent organizational, communication and interpersonal skills
• Effective time, cost and resource management skills
• Effective team communication skills within a global team with a variety of backgrounds and time zones
• Working knowledge of word-processing and data management software (Word, Excel, and PowerPoint)

• M.D. with relevant medical experience (post graduate Fellowship or Qualification desired)
• Experience in a pharmaceutical or biotech company, especially in early stage, exploratory clinical development of drugs and biologics or equivalent experience required