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Job Details

Clinical Set Up Specialist

Company: Chiltern
Location: Frimley Business Park in Camberley
Reference: MLJCSS5
Closing Date: 15 Dec 18
Type: Permanent
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Office based full time. Frimley Business Park. Focus on UK and Ireland Start Up Activities.

Requirements:

Job Background

Chiltern Source acts in a similar way to that of a staffing solutions provider. Chiltern Source supplies high quality and experienced clinical professionals to the pharmaceutical industry

One of our Clients (a top ten pharmaceutical company based in Surrey) is seeking a Clinical Trials SET UP SPECIALIST. You would be employed by Chiltern Source on PAYE permanent salary plus benefits and seconded out to a the ten pharma company on a rolling yearly contract.

Chiltern and our pharma partner are currently in a very close strategic partnership whereby we actively encourage and enhance career development of our contractors within the pharma company operations start up group. This allows for long term promotional prospects for successful candidates.

This is a full time office based role based at junction 4 off the M3 in Frimley Business Park.

The role would suit candidates who are particularly interested in study start up activities in the UK and Republic of Ireland.

If you have awareness of the current regulations for ethics and R and D approvals this will be a major advantage in your application. You don't necessarily have had to put the submission packages together but you will have an understanding of the process PLUS experience of liaising with investigational sites, negotiating costs (using the costing template).

We particularly welcome applicants from within the NHS who have clinical trials start up expertise/governance and who are looking to make the move into commercial pharma operations.

You may have been a study site coordinator or research nurse perhaps.




 

Job Purpose

To provide an efficient and professional ethics and R&D set up service within required timelines according to company SOPs and ICH GCP guidelines and to provide advice and knowledge to project managers and clinical associates regarding the ethics / regulatory processes in the UK and Republic of Ireland.

Major Accountabilities

Accountable for rapid study set up for all clinical trials across UK Operations and ensures that they are provided with a first in class study set up service.

Works closely with Clinical Set Up and Logistics Manager to identify process improvements for a more efficient
service of ethics and trial set up.

Advises clinical project teams and department with regards to new processes and procedures concerning
ethics and R&D processes and advises Project Managers and field based CRAs on submission timelines.

Proof reads ethics submissions and documentation for Clinical Project Managers and liaises with Medical Advisers
when needed.

Takes the lead on new Regulatory department processes and trains team appropriately.

Performs site monitoring activities such as unmasked monitoring and site drug supply management when required.

Collates, prepares and submits REC and SSI applications to the earliest possible review meetings following
NRES and ICH GCP and collates, prepares and completes R&D applications for R&D submissions during trial
set up period.

Is responsible for contract / budget negotiations with R&D/PCTs for ICRO clinical trials

Responsible for clinical trial set up, facilitates preparation and collection of country and site level documentation
to ensure drug shipment without delay.

Is accountable for timely distribution of trial safety data for specified products as per regulatory requirements to
ethics and R&D departments and well as the submssion progress and end of study clinical reports to SOPs and NIPs and local authority requirements

Liaises with Global interfaces and other departments to ensure correct reporting documentation is received for submission




 

The role would suit candidates who are particularly interested in study start up activities in the UK and Republic of Ireland. If you have awareness of the current MHRA regulations for ethics submissions and R and D approvals this will be a major advantage in your application. We particularly welcome applicants from within the NHS who have clinical trials start up expertise in perhaps a governance role and who are looking to make the move into commercial pharma operations.You may have been a study site coordinator or clinical trials coordinator for example OR research nurse OR perhaps a CRA who is now looking for an office based role with minimal travel
 

We definitely need someone who can work autonomously and be accountable/responsible for a successful site activation. You must be an excllent communicator with good negotiation skills and a drive for success.


 

Salary

On Application

Position Type

Contract
Full Time or Part Time

Contact

Email Marc Joseph - marc.joseph@chiltern.com
01753 216664

Apply for this job: Clinical Set Up Specialist

Contact Information:

Address:  London, UK
Covance Clinical and Periapproval Services Ltd Osprey House Maidenhead Office Park Westacott Way Maidenhead
SL6 3QH
England
Tel:  +44 (0) 1753 512000
Fax:  +44 (0) 1753 511116
Website:  Visit Our Web Site

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