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Clinical Trial Manager/Sr. Clinical Trial Manager, Hemoglobinopathies - United States, United Kingdom, Switzerland  

Company managed [?] Still accepting applications
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Posted on : 26 April 2017

Project Description

Position Summary
  • Reporting to the Head of Clinical Operations, this individual will have primary responsibility for trial management within hemoglobinopathy indications. 
  • The successful hire will adhere to best practices ensuring rigor and high quality execution of clinical trials from FIH through commercial marketing authorization.
  •  This person will manage cross functional relationships with internal and external stakeholders and be the clinical operations representative to the hemoglobinopathy program clinical sub-team. This individual will be hands on with trial sites fostering relationship development with KOLs. 
  • This is a high visibility position with great impact potential.   



Responsibilities 
  • Responsible for managing CROs/vendors for assigned trials ensuring adherence to defined scope of work and budget 
  • Identify issues and implement solutions to ensure timelines are maintained 
  • Develop and maintain tracking tools for clinical trials including study and monitoring visits, sample tracking, data entry and action item progress 
  • Assist with the drafting of protocols, informed consent forms, study operations guidelines and other study plans 
  • Develop trial specific training tools for site utilization 
  • Oversee maintenance of the eTMF 
  • Work with company  financial management to reconcile monthly actual and forecast budgets 
  • Monitor and/or co-monitor clinical trial sites 
  • Plan and coordinate advisory boards, investigator meetings and CRA trainings 
  • Work collaboratively with supply chain to ensure seamless collection/manufacture/shipment of cells 
  • Develop project-specific procedures and processes 
  • Recommend and follow up on corrective actions 
  • The candidate must maintain a high standard of professionalism, and confidentiality in this role and must be able to problem solve, communicate effectively, and trouble-shoot creatively 


Minimum Qualifications
  • BS/BA/BSN – health/science related field preferred 
  • Minimum 3-4 years’ relevant industry experience including at least 1 year of trial management experience. 
  • Excellent communication, writing and presentation skills 
  • Demonstrated ability to work independently as well as in a team environment and seek resources as necessary. 
  • Ability to assess complex issues and propose viable solutions 
  • Demonstrated ability to lead and organize team meetings 
  • Ability to foster effective relationships with vendors, investigators and colleagues 
  • Ability to contribute technical expertise to the various aspects of the clinical trial process. 
  • Knowledge of industry standards as applied to ICH guidelines, GCPs and the CFR 
  • Proficiency in study monitoring activities 
  • Knowledge of the infrastructure and operational characteristics of CROs and centralized services. 
  • Demonstrated effective time management skills 
  • Must be willing to travel domestically and internationally up to 15-20% 


Preferred Qualifications
  • MS or advanced degree 
  • 5 or more years in a Clinical Operations Management role 
  • Global trial management experience 
  • Prior Clinical Monitoring and/or CRO experience 
  • Knowledge of First in Human trial management 
  • Experience with hematology and/or transplant 
  • Experience with cellular therapy trial management 


Competencies
  • Adaptability/Flexibility – The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands 
  • Communication and Teamwork – The ability to effectively express ideas in written and oral context. The ability to work co-operatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals. 
  • Effective Planning - Embedding discipline and thoroughness in our approaches. 
  • Perseverance – Pursues tasks with energy, drive and initiative, even in the face of adversity. 
  • Problem Solving – The ability to understand a situation, task or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related. 
  • Relationship Building – Builds and maintains productive working relationships across a diverse spectrum of people.