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Job Details

Clinical Project Leader

Company: Chiltern
Location: Office based Milan
Reference: NC899968
Closing Date: 15 Sep 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Clinical Project Leader - working for a leading Pharmaceutical company in Milan

Requirements:

Job Background

JOB BACKGROUND

The Source department of Chiltern acts in a similar way to that of a staffing solutions provider.  The department is currently seeking a Clinical Project Leader in Italy to work for our client a leading pharmaceutical company.  Candidates will be employed through Chiltern’s Italy entity to work directly for our client office based in Milan.

 

  • Participate in the assessment of trial feasibility.
  • Make a selection of investigators.
  • Preparation of submission files to the Ethical Committees and assists with the Competent Authority submissions.
  • Preparation of Clinical Trial Agreements.
  • Prepare the clinical trial budget (AED).
  • Write/validate the technical and/or administrative documents which are necessary for the trial and makes the corporate documents fit the local regulations.
  • Organize the local investigators meetings, when required.
  • Ensure satisfactory/timely initiation of study centres, in particular ensure that the investigators are perfectly informed of the trial specificities and of its organization.
  • Ensures good follow-up of the centres, i.e. co-monitoring visit, assessing the monitoring reports, following the recruitment.
  • Participate locally to the setting up of audits carried out by the Corporate ICQA; coordinate the answers and follows up the possible corrective actions.
  • Ensure an efficient liaison with designated IP support.
  • Check the payment of the clinical trial payments, in accordance with the CTA.
  • Ensure that tolerance items are collected and reported
  • Make sure that centres are properly closed i.e.  files archived, IP and trial material collected.
  • Informs the investigators and the Competent Authorities/ Ethical Committees of the trial results.
  • Ensure the update of IMPACT.
  • Train the CRAs to the study specificities.
  • Work with the Clinical Research Operations Manager and Field Team Managers to co-ordinate the activity of the CRAs working on the study (centres allocation, workload
  • Care for the implementation of the study instructions.
  • Ensure the setting up of the study files inside the CRU.
  • Inform the Clinical Project Manager of the progress of the trial and of the difficulties encountered, makes a review with him/her of the adequate strategy to be set up.
  • Make sure that the International Clinical Development receives all required data on the trial progress.
  • Participate in the meetings related to the trial and organized by the International Clinical Development.
  • Acquire, maintain and expand knowledge in key therapeutic areas and clinical research methodology in order to communicate effectively with experts both inside and outside the company.

 

Candidates must have Clinical Project Management experience working for a global CRO or Pharmaceutical company

Must be fluent in Italian and speak a good level of English

 

To apply for this position, please send your CV to nicky.cooke@chiltern.com - nicky.cooke@chiltern.com, for a confidential discussion please call Nicky Cooke on + 44 1753 216 729.

For more extensive information about Chiltern, please visit our web site at www.chiltern.com

Please note that if your experience does not mirror that of our requirements for this role you may not receive a response.

PLEASE NOTE: AGENCY OR THIRD PARTY APPLICATIONS WILL NOT BE CONSIDERED. THANK YOU.

Candidates must be eligible to work in Italy

Keywords

Clinical Project Leader, Clinical Project Management, Clinical Trials, Italy, pharma, pharmaceutical

Salary

Negotiable

Position Type

Permanent
Full Time

Contact

Email Nicky Cooke - Nicky.Cooke@chiltern.com
+44 (0) 1753 216729

Apply for this job: Clinical Project Leader

Contact Information:

Address:  London, UK
171 Bath Road Slough Berkshire
SL1 4AA, UK
England
Tel:  +44 (0) 1753 512000
Fax:  +44 (0) 1753 511116
Website:  Visit Our Web Site

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