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Clinical Operations Manager

PSI

Warsaw, Poland

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.

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