Full Time Permanent

(SSU) Study Start Up Manager

Urgent
Posted 2 weeks ago
Europe
Application ends: September 30, 2021
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Job Description

Our client is a Oncology focused mid-sized CRO client who are looking for a Study Start Up Manager to join there successful and growing European team. They have extensive growth plans as a company over the new two years to double in size across there current locations Europe, UK and US.

Coordinating and controlling pre-defined study start-up activities across the whole department, keeping within budget, time and ensuring good quality. You will be directly working with Project Manager, communicating with the sponsor, study team and other departments.

Permanent – Fully Remote Working – Across Europe – Excellent Salary & Progression  

Duties

  • Main responsibility ensuring timelines, budgets of good quality from projects
  • Adhering to protocol, ICH-GCP & local regulatory requirements when required
  • Being the main point of contact for potential clients, sponsors, and internal team
  • Presenting during in external kick off meetings, study familiarization meetings and other sponsor meetings
  • Developing & growing the regulatory and start up intelligence
  • Actively mentoring and developing team members
  • Being the SME in the field of Study Start Up activities to evaluating and improving of processes & procedures in Quality Management
  • Forming good repour and long-term client relationships
  • Taking part in client evaluations, client visits and bid defences
  • Supporting new study protocols
  • Performing internal & external audits when required

Requirements

  • Degree within life sciences, Healthcare, or business
  • 2+ yrs within Study Start Up
  • 5+yrs working within CROs
  • Excellent knowledge of ICH-GCP, GDPR, HIPPA, Regulations
  • Great communication skills
  • Outstanding problem-solving skills

Apply

AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations