Clinical Project Leader x2 in Luton

03 Dec 2018
31 Dec 2018
Contract Type
Lucy Stendall is recruiting for 2 Clinical Project Leaders to join a company in the pharmaceutical industry in Luton on a 12 month contract.

The Company:
A multinational pharmaceutical and biopharmaceutical company who focus on developing new medicines.

The Location:
Luton is a large town in the South East of England located 32 miles north of London.

The Role:
• Overall responsibility for the study commitments within the country, for timely delivery of data to required quality as per SMA.
• Lead LSTs consisting of CRAs and study administrator(s).
• Lead and optimise the performance of the local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations and to update other study team members on study matters.
• Lead development of Local Monitoring Plan as per Targeted Monitoring guidance from respective Study Team.
• Contribute to review of monitoring visit reports and pro-actively advice the Monitor(s) on study related matters.
• Perform any required co-monitoring & QC visits with CRA(s).
• Applies Risk based monitoring principles and techniques.
• Proactively identify and facilitate resolution of complex study problems and issues.
• Organise regular Local Study Team meetings on an agenda driven basis.
• Actively work towards achieving good personal relationships with all Local Study Team members.
• Report study progress/update to the Study Management Organisation (SMO) Study Leader/Team.
• Contribute to patient recruitment strategy including regular communication with concerned Investigators as necessary.
• Communicate and co-ordinate regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters.
• Coordinate the process for selection of potential Investigators considering capability, competence, etc, of the hospitals/sites.
• Plan and lead national Investigator meetings, in line with local codes.
• Assist in forecasting study timelines, resources, recruitment, budget, study materials and drugs.
• Work in close coordination with Study Drug Coordinator to create a robust Drug Consumption Plan.
• Ensure timely preparation of country SMA, fSMA and Master CSA.

Your Background:
• Minimum University degree and / or equivalent, preferred in biological science or healthcare-related field.
• Minimum 3-5 years' experience in Clinical Research, including established experience in clinical project management.
• Excellent knowledge of spoken and written English.
• Good ability to learn and to adapt to work with IT systems.
• Office based role in Luton.
• Ability to travel nationally and occasionally internationally.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.  Please quote reference KA44092 in all correspondence.

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