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Randstad – Clinical Study Manager (CSM)

Clinical Study Manager (CSM)

Are you an experienced and talented Clinical Study Manager with a strong educational background in Life Sciences, keen to work for a leading CRO?
If you want to build a stronger, more sustainable future and cultivate your career as a Clinical Study Manager read below and apply here.

For this role you are offered a competitive remuneration package and a dynamic working environment.

What is expected of you:

You will manage assigned clinical trial(s)/programs including timelines, budgets, resources, and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines.

Key Accountabilities

  • Overall coordination and management of clinical trials from startup to closeout
  • Budget and Timelines Management
  • Contract Negotiations
  • Vendor Management. Develop outsourcing specifications on vendor requests for proposal and scope of work agreements
  • Work closely with external and internal stakeholders in project initiation phase to define scope, schedule, cost and budget
  • Ensure all project deliverables meet customers’ accurate forecasts
  • Support the Clinical Study Team
  • Identify and provide solutions to clinical development issues or risks
  • Participate as appropriate in internal and external audits
  • Mentor staff, coach CRAs and serve as a resource for new employees
  • Demonstrate flexibility, positive thinking, problem solving attitude and an appetite for numerous projects of varied shape and size
  • Promote a healthy working environment by leading projects’ teams by example
  • Communicate effectively with all other study team members at local & global level

For this role you will be expected to have the following:

  • Life Sciences or related degree
  • 5 years of experience in interventional clinical trials and at least 2 years of experience as a Study Manager
  • Thorough understanding of country level regulations, ICH and GCP guidelines
  • Thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs
  • Fluency in written and oral English
  • Computer literacy
  • Ability to lead a cross-functional team in a matrix environment
  • Strong interpersonal, negotiation, verbal and written communications and presentation skills
  • Experience in project organizational structure development, team/resource management and stakeholder management
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