Regulatory & Start Up Manager

PURPOSE
Manage the delivery of all required start-up, maintenance and regulatory activities for selected studies 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.
RESPONSIBILITIES
 Oversee the execution of Start Up and/or Maintenance for assigned projects in accordance with the agreed RSU strategy.
 Implement and maintain the RSU Management Plan in accordance with the Scope of Work and Project Plan, within the
agreed project strategy.
 Ensure collaboration across RSU, including communication with countries, to successfully deliver the agreed project scope
in compliance with the RSU Management Plan.
 Assist with creation and/or review of technical and administrative documentation to support business development and
enable study initiation and maintenance, as required.
 Provide overall guidance and oversight of multi-site projects 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 execution of the RSU plan.
 Contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support
assigned studies and wider company, as required.
 Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out
of scope activities as required.
 Ensure appropriate quality standards (following RSU Management Plan and relevant Work Instructions) for the duration of
Start Up (or Maintenance, as applicable).
 Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools,
timelines and project plans with project specific information.
 May participate in developing long standing relationships with preferred Quintiles customers.
 Support delivery of presentations/training to clients, colleagues and professional bodies, as required.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
 Good negotiation and communication skills with ability to challenge
 Good interpersonal skills, a strong team player
 Good understanding of regulated clinical trial environment and knowledge of drug development process
 Experience in regulatory and/or technical writing
 Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
 Ability to exercise independent judgment taking calculated risks when making decisions
 Good leadership skills, with ability to motivate
 Good organizational and planning skills
 Good presentation skills
 Good understanding of study financial management
 Good attention to detail
JOB DESCRIPTIONPage 2
 Ability to work on multiple projects balancing competing priorities