Regulatory and Start Up Manager

4 weeks ago

Bloemfontein, Orange Free State, South Africa IQVIA Full time
Job Overview

As a Regulatory and Start Up Manager at IQVIA, you will be responsible for directing and managing the delivery of site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. This includes pre-award activities, oversight of the scope of work, budget, and resources.

Key Responsibilities
  • Oversee the execution of site activation and 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.
Requirements
  • Bachelor's Degree in Life Sciences or related field.
  • 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 the ability to challenge.
  • Excellent interpersonal skills and strong team player.
  • Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects.
  • 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 the 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.

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