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Clinical Research Manager Sweden,  

BioGaia (company)


Posted on : 29 April 2017

Project Description

Description:
  • Our company is now expanding the Clinical Research Group with a Clinical Research Manager.
  •  The Clinical Research Manager (CRM) is a proven leader in clinical management, planning, executing and reporting on clinical study programs. 
  • The role includes a deep scientific knowledge and understanding to be able to develop new protocols and to build and work close to external Key Opinion Leader (KOL) networks. The CRM also provides support internally to project teams including marketing and sales.
  • The position is part of the Discovery & Research Team and is located at our headquarters International travelling is a part of the position. 


Overall Responsibilities Business objectives:  
  • Contribute to mid- and long-term pipeline strategies as well as creation and implementation of prioritized clinical study programs 
  • Identify, develop and act on interesting research ideas in accordance to priorities and company goals 
  • Understand and support global project goals including the development of KOL network, support sale and marketing activities 
  • Attend and contribute to off-site meetings and external conferences  


Clinical trial management: 
  • Evaluate and handle feasibilities from both scientific and business perspective 
  • In collaboration with relevant experts, develop clinical protocols and take full responsibility for the scientific content in line with company strategy priorities 
  • Identify and develop suitable study sites for clinical programs 
  • Managing and supporting of the execution of the clinical trials, including handling of all documents, negotiation and follow up on budgets, ensure timelines 
  • Ensure compliance with applicable regulations, guidelines, and corporate policies 
  • On-site monitoring when applicable 
  • Full responsibility for CRO-management 
  • Evaluate study results and take actions on next step in the program   


Education and Experience
  • Scientific/Medical university degree  preferable within microbiology or molecular biology 
  • Minimum five years  experience in clinical research, with at least 3 years of clinical project/study management 
  • Experience qualifying & managing external vendors (e.g. CRO, Central labs) 
  • Experience in creating, writing, reviewing and editing study protocols as well as clinical study reports 
  • Demonstrate knowledge of Good Clinical Practice and other applicable regulations governing clinical research 
  • KOL selection, management and development  


Mandatory skills and requirements: 
  • Demonstrate problem-solving and interpersonal skills:  
    • Ability to determine appropriate action in response to problems of varying complexity 
    • Must have a can-do  attitude and a strong desire to take ownership of many different projects 
    • Driven by curiosity and eager to find solutions   
  • Excellent organization and communication skills, including experience dealing with decision makers, such as physicians, key opinion leaders, scientists, regulators and policy makers 
  • Good networker 
  • Strong wish to join a small company, a sense of responsibility, ownership and execution as well as a willingness to work in a fast-paced environment 
  • Ability to work independently and manage multiple projects and timelines, while maintaining focus 
  • Ability and willingness to travel both domestically and internationally 
  • Fluency in both Swedish and English. Other language skills are an asset  

Locations

112 27 Stockholm Sweden

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