Senior Clinical Trial Manager

2 weeks ago

London, UK, United Kingdom Hays Full time

Global Pharma is looking to recruit an Experienced Senior Clinical Study Manager,

Acts as both Country Study Manager (CSM) and early start up lead in the EU as required.

Responsible for the leading the local portion of assigned study (or studies) and ensures the effective and efficient delivery of country/region operational aspects in accordance with the study milestones, study specific plans, ICH/GCP standards, Global SOPs, local operating guidelines and local regulatory requirements.

Provides leadership to Local Study Team (LST) and leads site activation, recruitment, retention, and site closure activities of CRO local team in the responsible countries/region(s).

Provides local expertise, regulatory knowledge and strategic planning to Study Leader (SL) for successful overall study delivery and completion.

Communicates effectively and leads LST to ensure that all stakeholders are aligned and processes are streamlined

Review protocol synopsis/study design, master consent form and clinical development plans from EU/UK regional operation point of

Lead country selection discussions from operational and/or regulatory point of view in the EU/UK

Conduct research into new indications and identify EU region Key Opinion Leaders (KOLs), manage consultancy agreements and lead consultancy meetings with KOLs

Lead feasibility survey in the EU/UK in collaboration with Study Team (ST)/CRO as required

Lead/support early outreach to patient advocacy groups (PAGs) where applicable

Represents the Local Study Team (LST) to HQ and service providers’ local study team

Manager and oversight of CRO performance and issues resolution/escalation. Identify systematic issues and coordinates any corrective action for the responsible countries/region(s).

Oversees CRO regional budget and reports to SL. If applicable, manages local affiliate study budget.

Provides local expertise to ensure operational feasibility and delivery of the overall study

Proactively manages into study level subject recruitment plan and retention strategies created by CRO and the study team based on site feasibility data from a country/regional perspective

Oversees CRO study conduct in the responsible countries/region(s) in line with overall study team plan

You will need

  • Degree level with an excellent ability to speak and write English to a high standard
  • At least 8 years clinical trial management experience across Europe
  • Experience of early phase studies
  • Excellent organisational and communication skills
  • Previous CRO management experience

Hybrid role one day in the office a week

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