Contract Clinical Project Leader

A well-known global pharmaceutical company with leading products across various therapeutic areas is looking to hire a Contract Clinical Project Leader. This vacancy is an exciting opportunity to work at a top global pharmaceutical company that has a workforce of more than 6,700 employees across multiple sites in the UK.

Job Responsibilities

• 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 company 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.
• Ensure completeness of the Study Master File and ensure essential documents are sent to SMO/Hub location/site.
• Ensure local Serious Adverse Event (SAE) reconciliation takes place.
• Facilitate translation of documents (ICFs, patient diaries, participation cards, etc) through external providers.
• Ensure timely submission of proper application/documents to EC/IRB.
• Work together with Regulatory Affairs to ensure timely delivery of proper application/documents for submissions to Regulatory Authority.
• Set up and maintain the study in IMPACT at study country level.
• Ensure accurate payments related to the study are performed.
• Participate in training and coaching new members of the Local Study Team ensuring compliance with ICH/GCP and company Procedural Documents.
• Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Study Master File.
• Plan and lead activities associated with audits and regulatory inspections in liaison with Clinical Process Manager and QA.
• Provide input to process development and improvement.
• Provide regular information to Line Managers (SMM Country Head/Clinical Research Manager (CRM)) at country level on study/ies and planned study milestones/key issues.
• Update Line Managers (CRM) about the performance of the CRAs.
• Ensure that study activities at country level comply with local policies & code of conduct.
• For CRA work, see Monitor Job Description
• Assist Line Managers (CRM) in efficient functioning of the department at country level.
• Prepare and maintain study budget at country level in ACCORD.
• Liaise with Local Compliance Officer regarding payments to Investigators to ensure these are in accordance with local requirements.
• Timely preparation and support to process of registration of applicable clinical studies in country-specific or regional websites.
• Ensure that clinical and operational feasibility assessment of Study Design Concept and Clinical Study Protocol is performed to highest quality.
• Keep track on research intelligence in local markets.
• Support SMM region in initiatives/activities as agreed with Line Manager (CRM).

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 207 4400 639 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.