Senior Clinical Trial Specialist job in London, England

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

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Contract

Discipline: Clinical Trial Assistant (CTA)

Location: United Kingdom

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

An opportunity to take on the Regional Operations Lead role has become available in the UK. This is a contracted role as a Senior Clinical Trial Specialist. You will lead responsibilities include managing issues and opportunities that impact regional study timeline, quality and budget; overseeing the CLO team, vendors and CRO for the study in the region; and escalating regional decisions, issues and risks to the Study Operations Lead.

Job Responsibilities

Drive day-to-day management of assigned vendors Communicate study performance expectations to vendors, manage and track vendor performance metrics at a study level
Develop country/sites specific ICFs
Manage activities related to Startup as delegated by the SOL Develop study specific documentation as delegated by the SOL Contribute to the management of country and site feasibility assessment
Contribute to the management of confidentiality agreement execution, budget and contract negotiation with selected sites in collaboration with Legal and Business Operations Provide support in the management of Regulatory document collection and tracking for sites participating to studies
Contribute, as required, to the management of Institutional Review Board/Ethics Committee (IRB/EC) related activities from submission to approval
Prepare site staff/CRO training and investigator meeting materials, and present at investigator meetings as assigned
Manage and track vendor adherence to SOW and oversight plan for assigned vendors Lead protocol deviation meetings, if assigned
Contribute to or be responsible for the development of vendor specific timelines ensuring alignment with study level timelines
Manage Change Order and Change Negotiation Form (of vendors) processes, in collaboration with Business Operations as delegated by SOL/ROL/SETL
Review and approve invoices for assigned vendors Ensure investigator payment: site setup, pass-through processing, visit payment processing and funding processing

Skills and Requirements

Over 5 years clinical study management experience within Pharma or Biotech is required.
Strong vendor management experience is required.
CRA background and experience in co-monitoring highly desirable
Experience in highly complex therapy areas preferred.
Demonstrable multitasking, project management, and execution skills.
Good interpersonal skills, including communication, presentation, persuasion, and influence.
Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
Proficiency with computer skills, such as MS Office.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-70834303_MP1

Related jobs

Clinical Research Coordinator

Salary

Highly Competitive Salary

Location:

Philadelphia, USA

Proclinical is seeking a dedicated and enthusiastic Clinical Research Coordinator who is passionate about clinical-translational research in the field of head and neck cancer