clinical study manager csm - halandri

posted
contact
Dora Tzevelekou, Randstad Hellas
job type
permanent
apply now

job details

posted
location
halandri, attica
sector
life sciences
job type
permanent
reference number
33677
contact
Dora Tzevelekou, Randstad Hellas
phone
2166001387

job description

Are you an experienced and talented Clinical Study Manager (CSM) with a strong educational background in Life Sciences, keen to work for a leading CRO? 

Great news for you, we are looking for an experienced Sponsor dedicated Clinical Study Manager (CSM).

If you want to build a stronger, more sustainable future and cultivate your career as a Clinical Study Manager (CSM), please apply now!

benefits

The company offers the following benefits for this Clinical Study Manager (CSM) role:

  • Competitive remuneration package
  • Dynamic working environment, focused on company’s values

responsibilities

The Clinical Study Manager (CSM) we are looking for 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. Responsibilities also include providing matrix management of functional area representatives to the cross-functional clinical project teams. 

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

qualifications

The ideal candidate for the Clinical Study Manager (CSM) role 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

skills

  • Ability to lead a cross-functional team in a matrix environment
  • Strong interpersonal, negotiation, verbal and written communications and presentation skills
  • Proven complex problem solving and decision-making skills
  • Strong leadership and communication skills
  • Experience in project organizational structure development, team/resource management and stakeholder management
  • Balance among drive for results, customer focus and realistic goal/milestone setting

experience

  • 5 years in interventional clinical trials

information

If this sounds like you, we want to hear from you today! Should you need additional information,  please contact me Dora Tzevelekou at 2166001387.

Please note that after the screening of all the CVs received, we will only contact the candidates who meet the requirements of the job to arrange an interview. All applications are considered strictly confidential.