PURPOSEDirect and manage the delivery of all required start-up, maintenance and regulatory activities for selected studies or multiprotocol programs as determined by either the agreed algorithm or the Sponsorâ s requirements, including pre-award activities,oversight of the scope of work, budget and resources.
RESPONSIBILITIESÂ· Oversee the execution of Start Up (including pre-award / bid defense activities) and / or Maintenance for assigned projects inaccordance with the agreed RSU strategy, adhering to project timelines.
Â· Develop, implement and maintain the RSU Management Plan according to the Scope of Work and Project Plan, within theagreed project strategy, resolving project related issues where required.
Â· Ensure collaboration across RSU, including communication with regions and countries, to successfully deliver the agreedproject scope in compliance with the RSU Management Plan.
Â· Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation andmaintenance of clinical trials, whilst enabling compliance with regulatory requirements.
Â· 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.
Â· 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 subsequentexecution of the RSU plan.
ÂREQUIRED KNOWLEDGE, SKILLS AND ABILITIES.Â· Strong negotiation and communication skills with ability to challenge.Â· Excellent interpersonal skills and strong team player.
Â· Good regulatory and / or technical writing skillsÂ· Good leadership skills, with ability to motivate, coach and mentor.
Â· Ability to exercise independent judgment taking calculated risks when making decisionsÂ· Good presentation skillsÂ· Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
ÂMINIMUM REQUIRED EDUCATION AND EXPERIENCEÂ·Bachelor's degree in life sciences or related field with 5 yearsâ relevant experience in a scientific or clinical environment.
Â· English Advance Level required.At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible â to help our customers create a healthier world.
The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.
Learn more at IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare â and human health â forward.
Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at QÂ² Solutions, contributes to our shared goal of improving human health.
Thank you for your interest in growing your career with us.EEO Minorities / Females / Protected Veterans / Disabled