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Clinical Operations Manager Warsaw Poland,  

PSI (company)


Posted on : 17 January 2017

Project Description


Description:
  • We are currently looking for a knowledgeable, entrepreneurial and proactive Clinical Operations Manager to lead and develop our Clinical Operations team.
  • If you are keen to ensure high-level team management, develop and drive departmental strategy in the region, provide us with your clinical trial expertise and guidance, strengthen our local presence in Poland and be involved in something new, outstanding and challenging, this job opportunity is perfect for you.


Responsibilities:
  • Line management of Clinical Operations staff 
  • Regional project oversight 
  • Communication point for investigators, authorities and vendors in the country 
  • Support with feasibility assessments 
  • Resources allocation to projects 
  • Monitoring of individual & country performance 
  • Hiring, training, integration and career development of Clinical Operations staff 
  • Implementation of quality systems and quality control, including quality assessment visits 
  • Resolution of audit/inspection findings 
  • Managing the budgets on the country level 
  • Enforcement of corporate procedures and policies 
  • Drafting reports, plans, development strategies; assistance with corporate development tasks 
  • Collaborating with all functional departments and divisions of the company 
  • Networking with local industry associations, professional communities, opinion leaders, consultants, etc.   


Basic qualifications:
  • University degree; degree in Life Sciences, PharmD or MD is a plus 
  • Post-graduate degree in Clinical Research and/or Business Administration is a plus 
  • At least 5 years  experience in Clinical Research 
  • At least 3 years  experience in Clinical Operations in Poland 
  • Demonstrated knowledge of project startup, monitoring, site management, project administration, and other relevant Clinical Operations  processes 
  • Adequate knowledge of applicable regulatory requirements and clinical startup activities in Poland 
  • Experience in performing and/or overseeing feasibility assessment requests 
  • Line management experience, including remote team management 
  • Experience in recruitment, training, performance appraisals, workload monitoring and resources allocation 
  • Team oriented with superior verbal, communication and interpersonal skills including a positive and professional attitude to tasks 
  • Strong time management, planning, organizational, leadership, and presentation skills, result-oriented approach 
  • C1 level in English, C2 level in Polish 
  • Proficiency in standard MS Office applications   


Preferred qualifications
  • Clinical Operations experience at an international or big local CRO 
  • Experience with bid defense meetings 
  • Basic financial knowledge and experience in budget manage   

Locations

POLAND WARSAW

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