Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		Job #07267 About our client Our client is a pharmaceutical company that develops, manufactures and commercializes pharmaceutical products. Our client has had six products approved by the FDA and has a pipeline of product candidates in development for itself and its collaboration partners. Position Location Senior Study Manager PA Salary Highly competitive package, commensurate with experience Responsibilities 1) Organize and lead study planning as well as reporting of assigned studies 2) Initiate and supervise outsourcing of clinical study tasks in line with the company strategy 3) Form and coordinate the Clinical Study Team 4) Ensure that all necessary functions are represented in the Study Team 5) Develop team objectives and specific team member(s) responsibilities 6) Ensure occurrence of regular Clinical Study Team meetings and recording of meeting minutes 7) Ensure quality conduct of the assigned clinical study 8) Track and report study progress 9) Communicate possible issues to study team and functional heads in effective and timely manner 10) Ensure completion of the clinical study 11) Anticipate, identify and manage critical path issues 12) Identify risk and success factors 13) Ensure that the clinical study is conducted within the assigned budget and time frame 14) Ensure availability of study medication(s) supply 15) Ensure that the clinical study is conducted according to the company’s or external collaborator’s (e.g., CRO) SOPs 16) Represent clinical study management at external meetings (regulatory, scientific, etc.) 17) Manage other Study Managers 18) Approve clinical study plans, budgets and timelines in collaboration with the function head 19) Oversee and mentor Study Managers to successfully plan and conduct clinical studies in all aspects (quality, time and budget) 20) Supervise Study Managers 21) Oversee medical monitor function (if qualified) 22) Provide medical and scientific input during study protocol development 23) Train internal and external members of Clinical Study Team on medical and scientific aspects of the study 24) Participate in investigator’s meetings 25) Review Adverse Events (AE) reporting and supervise serious adverse events (SAE) reporting in collaboration with the relevant functions 26) Review safety data as necessary 27) Review protocol deviations for medical relevance 28) Participate in the medial review of data listings 29) Review the relevant part of Statistical Analysis Plan (SAP) 30) Participate in medical coding decisions as necessary 31) Review medical aspects of study reports Requirements 1) BS 2) At least 5 - 7 years of experience in clinical development as Study Manager in phase 1 - 3 studies 3) In-depth understanding of clinical development process 4) Understanding of global regulations and guidelines relevant to clinical development 5) Experience in managing teams 6) Experience in participating in cross-functional teams 7) Strong written and oral communication skills in English 8) Proficiency in MS Word and Excel
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