Senior Site Activation Manager
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 andmaintenance phase as an integral member of the study management team.
· Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations; identifyregulatory 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 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
Join IQVIA’s Talent Network
Let’s stay connected. Join our global Talent Network to receive alerts when new opportunities become available that match your career ambitions.Join our network