Regulatory and Start Up Manager

Job Overview

Direct 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. Considering experience across EMEA locations. Sponsor Dedicated.

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.
  
  

• Bachelor's Degree Life sciences or related field Req
• 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.
• Strong negotiation and communication skills with ability to challenge.
• Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process.
• Demonstrated proficiency in using systems and technology to achieve work objectives.
• Good regulatory and/or technical writing skills
• Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines.
• Good leadership skills, with ability to motivate, coach and mentor.
• Good organizational and planning skills
• Ability to exercise independent judgment taking calculated risks when making decisions.
• Good presentation skills
• Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
• Excellent understanding of study financial management
• Proven ability to work on multiple projects balancing competing priorities.