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Job #03045

About our client Our client is a rapidly growing biotech company headquartered in Minnesota that is focused on the development and commercialization of therapeutics for oncology indications. The company has marketed products to support ongoing development, an experienced management team and board and an empowering corporate culture that is focused on the professional development of its employees. This is a great opportunity for the right candidate. Position Location Senior Clinical Trial Manager Minnesota Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage complex US/global pharmaceutical development projects professionally 2) Work with Pharma leaders to ensure that organizational and project objectives are achieved 3) Manage cross-functional teams to implement the operational plan for assigned indication/study 4) Work with the Pharma Team to draft and implement overall development strategy of assigned indication including clinical development plan 5) Manage, track and coordinate clinical operational activities specified in clinical development plans for their assigned indication and/or study 6) Write/coordinate the publication of the protocol, clinical management plan, monitoring plan, study-related manuals and SOPs (as necessary) 7) Direct all third party vendor clinical activities including CROs, investigative sites as well as central and imaging laboratories 8) Manage importation/exportation of clinical trial materials 9) Oversee development and implementation of clinical and safety databases, statistical analysis plans, CRFs and data-validation plans 10) Manage the writing and finalization of final clinical study report 11) Direct internal and external team members, communications as well as project meetings 12) Manage applicable timelines and budgets 13) Supervise external vendors and consultants including contracts, scopes of work, deliverables as well as variances from the budget 14) Maintain regulatory files and correspondence including authoring portions or all of annual reports, Investigator brochures and scientific abstracts 15) Assess out-sourcing requirements with VP of Clinical Development and VP of Operations 16) Set criteria for and review requests for proposal (RFPs) from CROs in collaboration with appropriate legal, operational and clinical research functions 17) Develop and foster outside relationships with key opinion leaders, collaborating researchers as well as research sites 18) Serve as Monitor and/or Auditor on selected projects Requirements 1) Ph. D. in Biological Sciences with minimum 7 years of clinical experience or MS in Biological Sciences with minimum 10 years of relevant experience 2) 7+ years of clinical experience with 4+years in trial/project management 3) Experience in oncology indications/trials and international/multi-country studies 4) Experience in international studies (should possess current passport) 5) Knowledge of clinical study designs 6) Understanding of FDA, ICH and regional regulations as well as cross-functional clinical operations/processes 7) Superb communication skills (verbal and written) 8) Excellent problem-solving and interpersonal skills 9) Willingness to travel internationally (minimal)