FSP RSU Line Manager

Employer
IQVIA
Location
Reading
Closing date
10 Oct 2020

View more

Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Permanent
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Manager, Regulatory and Start up - Client dedicated (FSP)Based anywhere in EMEADirect and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.Essential Functions
• Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations
Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required. Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable).Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.May take a lead role in developing long standing relationships with preferred IQVIA customers. Deliver presentations/training to clients, colleagues and professional bodies, as required. May be involved in activities related to monthly study budget planning and reviews.Qualifications
• Bachelor's Degree Related field Req
• 6 years clinical research experience, including 3 years experience in a leadership capacity. Equivalent combination of education, training and experience.
• Full knowledge of drug development process
• Full knowledge of applicable regulatory requirements, SOPs, and company’s Corporate Standards
• Strong knowledge of budget management and resourcing
• Considerable working knowledge of medical terminology
• Strong knowledge of Microsoft Office and e-mail applications
• Effective communication, organizational, interpersonal, and leadership skills
• Strong negotiation skills
• Ability to independently coordinate and manage new processes
• Ability to lead and motivate teams
• Ability to handle management/personnel issues
• Ability to work independently and to effectively prioritize tasks
• Ability to work well within a matrix team environment
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

At IQVIA™, we are committed to advancing human health and delivering real value and outcomes for customers and patients. We view each day as another opportunity to find new solutions and enable the next breakthrough.

IQVIA is a leading global provider of information, innovative technology solutions and contract research services dedicated to using analytics and science to help healthcare stakeholders find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA has approximately 55,000 employees worldwide.

Please visit our Careers Hub on PharmiWeb.Jobs: www.pharmiweb.jobs/minisites/iqvia-careers-hub/

Contact Us
  • 210 Pentonville Road
  • London
  • N1 9JY
  • GB
  • +44 (0) 20 3075 5000
  • Mini-site: IQVIA
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