Senior Global Study Lead - Late Phase job in Uxbridge, England

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Project/Study Manager (CSM/CPM)

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

A fantastic opportunity has arisen for a Senior Clinical Study Lead in the UK. In this role you will be responsible for the global executions of large, complex clinical trials from study design through study close out.

Job Responsibilities

Providing operational input into protocol development
Leading all aspects of and contributing to the development of study specific documentation e.g. case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
Supervising set-up and maintenance of study systems such as Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
Ensuring compliance with the clinical trial registry requirements
Providing input into baseline budget and timeline development and managing the study against planned budget, timeline and results
Leading risk assessment and identifies risk mitigation strategies at the study level
Running feasibility assessment to select relevant regions and countries for the study
Conducting site evaluation and selection
Leading investigator meeting preparation and execution
Monitoring progress for site activation and monitoring visits and acts on any deviations from plan
Handling development and implementation of patient recruitment and patient retention strategies
Monitoring data entry and query resolution and taking action on any divergence from agreed metrics
Overseeing and providing input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
Ensuring data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
Ensuring clinical project audit and inspection readiness through the study lifecycle and contributing to CAPAs as required
Supervising study close-out activities and contributing to clinical study report writing and review

Skills and Requirements

You have the capacity to understand and implement the strategic direction and guidance for respective clinical studies
You can take a proactive and self-disciplined approach to managing projects with a developed ability to meet deadlines and prioritise
You operate with a high degree of cross-functional agility using exceptional influencing and interpersonal skills
Bachelors' degree with a minimum of 8 years of relevant industry experience.
Direct experience managing global clinical trial operations is a must, including experience developing protocols and key study documents.
You will also need technical proficiency trial management software and MS applications to be considered.

To Apply

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