IQVIA Biotech
Associate Regulatory & Start-Up Manager
Homebased
Serbia, Bulgaria, Romania, Croatia
At IQVIA Biotech we partner with visionary biotech companies to transform innovation into patient impact. With dedicated teams, deep therapeutic expertise and a biotech tailored delivery model we accelerate clinical development from early phase through global registrational studies.
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. Will be overseeing submissions in European countries.
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 and Skills
Bachelor's Degree in Life Sciences or related field
3 years clinical research experience, including 2 years in start-up maintenance
Knowledge of EUCTR
Knowledge of global ICF processes
EAC and financial budget experience an advantage
In-depth knowledge of clinical systems, procedures, and corporate standards
Strong knowledge of medical terminology and regulations
Broad knowledge of clinical research
Strong knowledge of Microsoft Office and e-mail applications
Effective communication, organizational, and interpersonal skills
Effective presentation skills
Effective leadership skills
Ability to work independently and to effectively prioritize tasks
Ability to delegate
Ability to manage multiple projects
Attention to detail
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com