Assoc Mgr, Reg & Start-up - (R1031788) in São Paulo, BRA at IQVIA™

Date Posted: 7/10/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    7/10/2018
  • Job ID:
    R1031788

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Description

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 (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU strategy
  • Develop, implement and maintain the RSU Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy.
  • Ensure collaboration across RSU, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
  • Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
  • Provide specialist regulatory and technical scientific support to facilitate efficient initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements. Provide overall guidance and oversight of multi-regional 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 the bid process and subsequent execution of the RSU plan.
  • Assess and review the regulatory landscape and 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.
  • Act as CTA Line Manager.
  • Work with Quality Management to ensure appropriate quality standards for the duration 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.
  • Deliver presentations/training to clients, colleagues and professional bodies, as required.

Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • Fluent English
  • Bachelor's degree in life sciences or related field,
  • Relevant experience as CTA, Regulatory or Monitor
  • Strong leadership skills with ability to motivate, coach and mentor
  • Strong communications skills
  • Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
  • Thorough understanding of regulated clinical trial environment and knowledge of drug development process
  • Good organizational and planning skills and understanding of study financial management
  • Ability to establish and maintain effective working relationships with co-workers, managers and sponsors
  • Proven ability to work on multiple projects balancing competing priorities


We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.


Job ID: R1031788

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