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Clinical Project Manager

Posted on Mar 12, 2019 by Vine Resources

South East, South East United Kingdom
Research & Development
1 Apr 2019
Annual Salary
Contract/Project

My client is a Global Pharma company and requires a Clinical Project leader initially for 6 months to in support of the clinical development projects for the central nervous system.

Remote from home

Tasks

Development of a clinical development plan from phase 1 to submission for new indications (Fragile X syndrome, Progressive Myoclonal Epilepsy). This includes a review of the literature, consideration of regulatory guidelines, suggestions for relevant clinical endpoints and trial concepts, in particular also translational medicine studies.
Propose an outline and concept for phase 2 studies in Alzheimer Dementia
Provide a synthesis of literature review of adequacy of functional assessments for cognitive impairment in schizophrenia
Provide a synthetic overview of published studies in cognitive impairment in schizophrenia
Literature and database search about pathophysiological background and relevance of a specific mode of action for further indications
Evaluation and comparison of assessment tools for impulsivity in BPD, ADHD, Binge eating, substance abuse disorders (alcohol/cocaine/nicotine)
Critical Review and Input to translational Medicine studies in CIAS projects

Experience

Medical and clinical experience in a broad range of Central Nervous System disorders
Experience in operational and strategic aspects of clinical research and drug development
Experience in interactions with regulatory authorities
Able to work independently

You will be available to travel very occasionally at short notice in Europe otherwise the rest will be remote

Reference: 668328463