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 Czech Republic to work for our client a leading pharmaceutical company. Candidates will ideally be employed through Chiltern's Czech entity to work directly for our client however candidates working as a freelancer may also be considered. We are ideally looking for someone to start start as soon as possible in October. This position is office based in Prague, after several months one day of home-office could be possible.
• 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.
• At least 0.5 -1 year experience in Clinical project management or senior CRA who went through all stages of clinical project. • Must speak a good level of English
To apply for this position, please send your CV to , for a confidential discussion please call Julia thomson on + .
For more extensive information about Chiltern, please visit our web site at
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.