• Assoc Reg & Start-Up Mgr Jobs in China - 25367992

  • Iqvia
  • China
  • Save Job
  • 3 - 6 Years
  • Posted : above 1 month

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

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

Ability to work on multiple projects balancing competing priorities

Ability to establish and maintain effective working relationships with co-workers, managers and sponsors

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Bachelors degree in life sciences or related field, with 3 years relevant experience including demonstrable experience in a regional 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

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 R1071469

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Consulting Services
Functional Area : Bio Tech/R&D/Scientist
Role : Clinical Research
Salary : As per Industry Standards
Deadline : 09th Jun 2020

Key Skills:

Would you like to try out these free online tutorials?

People who search this job also searched for the following Keywords

Salary trends based on over 1 crore profiles

View Salaries

All rights reserved © 2018 Wisdom IT Services India Pvt. Ltd DMCA.com Protection Status