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Job Details

CTA required for top global pharma, Buckinghamshire

Company: DOCS Global
Location: Buckinghamshire
Reference: CTA-TG
Closing Date: 07 Mar 18
Type: Full Time
Salary (£): On Application
Benefits: pension, health insurance, 23 days holiday entitlement, etc

Job Summary:

Our client, a top global pharma and one of the Top pharma companies to work for, are seeking an experienced Clinical Trial Administrator to join their Clinical Operations team. The role is office based in Buckinghamshire with flexibility of working from home two days a week. The role will be supporting the CRAs and Clinical Project Managers in the delivery of the studies from phases II-IV across different therapy areas.

Requirements:

Responsibilities:

 

  • Partners with the Clinical Project Managers and CRAs to ensure overall site management and adherence to internal SOPs, policies and local regulatory requirements
  • Supports the local study team in performing site feasibility and/or country feasibility.
  • Maintains site level protocol information in Trial Management Systems (e.g. CTMS).
  • In liaison with the Clinical Project Managers , ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes.
  • Where applicable, works with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority approval process.
  • Supports the Clinical Project Managers or, where applicable the CRA, in providing the current and complete documents requested by the IEC/IRB and HA.
  • Supports the CRAs/Clinical Project Managers in collecting and maintaining all documents throughout the trial and post-trial in both eTMF and paper files.
  • Distributes, collect, review, and track regulatory documents, agreements and training documentation.
  • Collects and tracks Financial Disclosure information at appropriate time points.
  • Complies with relevant training requirements.
  • Region specific 
  • Negotiates site requested changes to the Confidential Disclosure Agreement; checks investigators and IEC/IRBs against exclusion databases, IEC/IRB registrations. Alerts Clinical Project Managers of any findings.
  • Prepares Trial Center File and prepare or co-ordinate the development of any other document and review them for completeness and accuracy.
  • Assist the Clinical Project Managers in conducting local investigator meeting or in making arrangements for the investigators participating in an international meeting.
  • Support the Clinical Project Managers in drug distribution process.
  • Provide administrative and logistical support to the Clinical Project Managers and CRAs in tracking progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence and other relevant tasks as appropriate
  • Supports the Clinical Project Managers compiling the List of Investigators for CSR is accurate and complete.

 

Experience required: 

  • Skills set corresponding with relevant clinical trial experience within NHS, Pharma or CRO.
  • Proficient in English language.
  • Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint).
  • Strong interpersonal and negotiating skills.
  • Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.

 

What is offered: 

  • Permanent opportunity via DOCS
  • Opportunity to grow and develop within a stable and successful environment 
  • Base salary
  • Pension
  • Private BUPA healthcare
  • Life Assurance
  • 23 days holiday
  • Smartphone
  • Laptop provided by client
  • Flexibility of working from home 2 days a week

 

For more information please contact Tanzina Guerni on: tanzina.guerni@docsglobal.com or call me directly on: 01628 493 517

 

KEYWORDS:

 

CTA, Clinical Trial Assistant, Clinical Trial Administrator, Clinical Trial Coordinator, Project Assistant, Clinical Trial Support, Phase I, Phase II, Phase II, Phase IV, Clinical operations, Buckinghamshire

Apply for this job: CTA required for top global pharma, Buckinghamshire

Contact Information:

Address:  DOCS UK
2 Globeside, Globeside Business park Marlow
SL7 1HZ
England
Reasons to work for Docs International
Tel:  +44 (0) 2380 688500
Fax:  +44 (0) 2380 688501
Website:  Visit Our Web Site

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