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Global Reg & Start-Up Manager / Site Activation Manager- based in US - (1808178) in Los Angeles, CA at IQVIA™

Date Posted: 12/6/2018

Job Snapshot

Job Description



Description

 PURPOSE
 
Direct and manage the delivery of all required start-up, maintenance and regulatory activities for multi-protocol 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.
 
 
RESPONSIBILITIES
 
  • The role holder may be required to cover all responsibilities mentioned below but will be expected to focus on certain responsibilities for periods of time.
  • Accountable for the oversight and execution of Start Up (from pre-award/bid defense activities up to Maintenance and Investigational Product (IP) release for all assigned projects in accordance with the agreed RSU strategy.
  • Responsible for the development, maintenance and implementation of the RSU plan according to the Scope of Work and Project Plan within the agreed strategy, escalating issues where required.
  • Ensure cross collaboration across RSU and communication with regions and countries to successfully implement the agreed RSU plan.
  • Provide overall guidance and oversight of multi-site projects during maintenance phase as an integral member of the study management team.
  • Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
  • Provide specialist regulatory and technical scientific support to facilitate efficient initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
  • 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.
  • Create, publish and review core scientific, technical and administrative documentation necessary for enabling study initiation and maintenance.
  • Assess and review regulatory landscape and contribute to collection, interpretation, analysis and dissemination of accurate regulatory intelligence. Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required. Work with Quality Management to ensure appropriate quality standards for the duration of the start up. 
  • Mentor and coach colleagues as required and provide technical guidance both within and outside the project.
  • Ensure accurate completion of relevant Clinical Trial Management System (CTMS) fields in accordance with role.
  • May take a proactive role in developing long standing relationships with preferred Quintiles customers.

Job Requirements

 
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • Good negotiating and communication skills with ability to challenge
  • Excellent interpersonal skills and strong team player; ability to co-ordinate and collaborate above, across and within complex projects.
  • Good regulatory and/or technical writing skills
  • Good understanding of regulated clinical trial environment and in depth knowledge of drug development process
  • Ability to exercise independent judgment taking calculated risks when making decisions
  • Good leadership skills, with ability to motivate, coach and mentor
  • Good organizational and planning skills
  • Good presentation skills
  • Understanding of study financial management
  • 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 7 years’ relevant experience including demonstrable experience in an international role; or equivalent combination of education, training and experience.
 
PHYSICAL REQUIREMENTS
  •  Extensive use of keyboard requiring repetitive motion of fingers.
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Regular sitting for extended periods of time.
  • Potential for frequent travel.
 

* Quintiles helped develop or commercialize 98 of the Top 100 best-selling products of 2015
* Quintiles has 36,000 employees conducting business in more than 100 countries
* Quintiles was named to FORTUNEâs Worldâs Most Admired Companies® 2016 list
* Quintiles was named as a 2016 Worldâs Most Ethical Company® by the Ethisphere Institute
Job ID: 1808178