DOCS Global

EU Clinical Study Manager / Hampshire / England

Hampshire (GB)
atractive package and career scope
09 Apr 2021
09 May 2021
Full Time
Contract Type
Experience Level

The Clinical Trial Manager main responsibilities are:

  • Leading the regional matrix team (e.g. CRA, CTA, etc.) to ensure delivery of country and site level study activities in alignment with the global study project plan
  • Identifying and resolving issues at a regional level
  • Collaborating with Global CTM to ensure country level study delivery is aligned with the global study project plan
  • Contributing to study-level risk assessments
  • Leading and continually review regional risk mitigation activities to ensure study delivery to plan
  • Overseeing regional insourcing/outsourcing partner deliverables to the required standards 
  • Ensuring regional, country and site vendor set-up, conduct and quality e.g. laboratories and equipment provisioning
  • Leading regional documentation and required tool and systems set-up
  • Contributing to regional aspects of Drug Supply Plan
  • Ensuring implementation of study(ies) in accordance with SOPs and ICH/GCP guidelines
  • Supporting audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate
  • Executing regulatory agency inspection readiness activities (e.g. TMF review, story board generation) within region
  • Supporting and contributing to Clinical Study Team(s)
  • Ensuring relevant systems are updated to enable accurate reporting of study progress and milestone deliverables
  • Ensuring key stakeholders are kept informed of study progress e.g. Global CTM, DOMs
  • Contributing to development of study-specific materials e.g. monitoring plan, study specific training documents

Participation in cross-functional task forces / process improvement groups

Basic qualifications

  • BA/BS/BSc or RN
  • Broad experience working in life sciences or medically related field, including general biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company)

Preferred qualifications

  • BA/BS/BSc in the sciences or RN
  • Ideally 7 years work experience in life sciences or medically related field, including preferably 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company.
  • Experience in oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc.)

What is offered

  • Permanent and full time contract of employment with DOCS seconded to our client
  • Office-based in East Leigh (Hampshire/UK) 3 days per week with 2 days homeworking flexibility
  • Great scope to develop your career further
  • Salary will depend on level of experience and skills
  • Structured on-boarding for all new joiners with company benefits to include annual leave, car allowance, and more.

For more information, please contact me with your latest CV.

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