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.
Experienced Professional Individual Contributor Who Works Under Minimum Supervision.
May mentor or otherwise help newer team members navigate processes. Responsible for making adjustments or recommended enhancements in systems and processes to improve performance of job area. Problems faced are predominantly routine though occasionally non-routine.
Essential Functions
- Oversee the execution of Feasibility, Site ID, 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 Feasibility, Site ID, 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 functional and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with functional/ 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 functional/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 functional/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.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com
