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Clin Lead (R1049586) in Reading, UK at IQVIA™

Date Posted: 12/5/2018

Job Snapshot

  • Employee Type:
  • Location:
    Reading, UK
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Local Study Manager - Homebased with travel to the Luton Office

This role is working in our  FSP model, outsourced to one of our Sponsors. Local Study Manager leads Local Study Teams at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines. In addition is expected to perform site monitoring if needed and is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
• Lead Local Study Teams consisting of CRAs/monitors and Clinical Study Administrators. 
• Lead and optimise the performance of the local Study Teams ensuring compliance with Sponsor Procedural Documents, ICH-GCP and local regulations and to update other study team members on study matters 
• LSM oversees, manage and coordinate monitoring activities from site activation through study closure at country and site level in accordance with the Monitoring Plan for the studies.
• Contribute to review of monitoring visit reports and pro-actively advice the monitors on study related matters. 
• 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 SMO Study Leader/Team including SMM STOM Lead. 
• Contribute to patient recruitment strategy including regular communication with concerned Investigators as necessary. 
• Risk management plan: Proactive management of sites in studies ongoing, implement actions plans for non-recruiting sites.
• Communicate and co-ordinate regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters.
• Coordinate the site selection process by identifying potential sites/investigators, perform initial Site Quality Risk Assessment, conduct Site Qualification Visits to evaluate suitability and quality risk.
• Plan and lead national Investigator meetings, in line with local codes
• Assist in forecasting study timelines, resources, recruitment, budget, study materials and drugs.
• Plan and coordinate applicable local drug activities (from local purchase or reimbursement to drug destruction).
• Participate in training and coaching new members of the Local Study Team ensuring compliance with ICH/GCP and Sponsor Procedural Documents.

Job Requirements
• Minimum University degree preferably in biological science or healthcare-related field
• Minimum 3 years of experience in Clinical Operations or other related fields (Medical Affairs-led studies or Academic-led studies)
• Excellent knowledge of spoken and written English
• Experience as CRA/clinical monitor
• Good ability to learn and to adapt to work with IT systems
• Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with maintained quality.
• Good knowledge of international guidelines - ICH/GCP as well as relevant local regulations
• Excellent understanding of the Clinical Study Process including monitoring and local data management handling.
• Excellent project management skills. 
• Excellent team building and interpersonal and communication skills.
• Excellent organisational skills and ability to prioritize and handle multiple tasks.
• Ability to have attention to detail.

    We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™

    Job ID: R1049586