IQVIA Biotech is a unique division specialising in working with smaller biotech and emerging biopharma clients and as such we have a vibrant, fast-paced working environment.
The sector we are in is cutting edge for therapies with un-met medical need.
IQVIA Biotech has an exciting position within its Start File Operations team for a experienced candidate to lead an established team of individuals working on multiple studies.
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.
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
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.
Equivalent combination of education, training and experience.