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Study Manager Niel Belgium,  

ETheRNA (company)

Posted on : 30 April 2017

Project Description

General Job Description  
  • The Study Manager will be responsible for the operational management and oversight of specific clinical studies within company s clinical development program. 
  • The Study Manager will work closely with the Clinical Lead and the CMO to ensure successful completion of all clinical deliverables within the required time frame and budget. 
  • This function reports into the Clinical Lead.  

Responsibilities and Duties    
The Study Manager s duties shall include, but not be limited to:  
  • Manage all clinical aspects of study from the protocol concept through the clinical study report; 
  • Oversee performance of CROs and third party vendors to ensure compliance with study protocol and in accordance with scope of work.
  •  Identify areas of concern and escalate to Clinical Lead, CMO and/or CRO as appropriate; 
  • Ensure studies are carried out according to study protocol, SOPs and ICH/GCP regulations; 
  • Develop and manage the study budget and maintain it within the agreed goals; 
  • Establish study milestones; 
  • Track and report on progress of study (both study deliverables and budget); 
  • Contribute to preparation of study related materials, such as study protocols, informed consent, case report forms; 
  • Ensure operational plans are developed, such as recruitment plan, monitoring plan, clinical supplies management, laboratory manual; 
  • Ensure that reporting of SUSARs is established and maintained during the study; 
  • Ensure identification and selection of investigational sites. Oversee study fee negotiations; 
  • Develop an ongoing data review plan to ensure that study objectives are met and determine appropriate action (if needed) in conjunction with study team; 
  • Develop and maintain good working relationships with investigators and study staff; 
  • Frequent interaction with the cross-functional internal team and external team(s). 

Job Requirements  
  •  Education:
    Master degree in bio-medical sciences (or related) or relevant experience in a similar position in the Biotech/Pharma industry.   
  • A minimum of 2-3 years of experience in managing industry sponsored clinical studies, including management of CRO/external vendors;
  • Experience in managing multi-country studies is a plus;
  • Experience in oncology studies is preferred. 

Other Qualifications, Skills and Abilities:
  • Quality minded, rigorous, autonomous and customer oriented;
  • Good knowledge of GCP regulations and guidelines;
  • Experience with an electronic data capture system;
  • Able to motivate the internal and external team to work efficiently;
  • Ability to foster teamwork and a collaborative atmosphere;
  • Fluent in English;
  • Well organized, well-structured, hands-on, result focused;
  • Strong management skills;
  • Enthusiastic, flexible and able to multitask;
  • Ability to set priorities and take initiative;
  • Excellent understanding of MS Office (Excel, Word, PowerPoint, Outlook). 

  • Exciting job in a dynamic and entrepreneurial environment with room for personal development 
  • Employment contract of unlimited duration with a competitive salary package 


2845 Niel Belgium

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