Direct 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 Sponsor’s requirements, including pre-award activities,
oversight of the scope of work, budget and resources.
· Oversee the execution of Start Up (including pre-award/bid defense activities) and/or Maintenance for assigned projects in
accordance with the agreed RSU strategy, adhering to project timelines.
· Develop, implement and maintain the RSU 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 RSU, including communication with regions and countries, to successfully deliver the agreed
project scope in compliance with the RSU Management Plan.
· 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 RSU plan.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES.
· Strong negotiation and communication skills with ability to challenge.
· Excellent interpersonal skills and strong team player.
· Good regulatory and/or technical writing skills
· Good leadership skills, with ability to motivate, coach and mentor.
· 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.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
·Bachelor's degree in life sciences or related field with 5 years’ relevant experience in a scientific or clinical environment.
· English Advance Level required.
At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.