Logo of Huzzle

Home

Matches

Explore

Manage

Regulatory and Start Up Specialist - South Africa

image

IQVIA

8d ago

  • Job
    Full-time
    Mid Level
  • Research & Development
    Healthcare
  • Pretoria

AI generated summary

  • You need a Bachelor's in life sciences, 3 years in clinical research, strong communication skills, project management ability, GCP/ICH knowledge, and understanding of regulatory requirements.
  • You will manage site activation, ensure regulatory compliance, prepare documents, track approvals, maintain databases, and provide support to project teams while monitoring progress and quality.

Requirements

  • Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
  • Effective communication, organizational, and interpersonal skills.
  • Ability to work independently and to effectively prioritize tasks.
  • Ability to manage multiple projects.
  • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
  • Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.
  • Understanding of regulated clinical trial environment and knowledge of drug development process.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Responsibilities

  • Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
  • Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
  • Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
  • Distribute completed documents to sites and internal project team members.
  • Prepare site regulatory documents, reviewing for completeness and accuracy.
  • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
  • Review and provide feedback to management on site performance metrics.
  • Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
  • Inform team members of completion of regulatory and contractual documents for individual sites.
  • Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
  • Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
  • Perform quality control of documents provided by sites.
  • May have direct contact with sponsors on specific initiatives.

FAQs

What is the primary role of the Regulatory and Start Up Specialist?

The primary role is to perform tasks associated with Site Activation activities in compliance with local and international regulations, SOPs, and project requirements.

What qualifications are required for this position?

A Bachelor's Degree in life sciences or a related field with a minimum of 3 years of clinical research or relevant experience is required.

What specific experience is needed related to safety reporting?

The candidate should have experience with CTF1, CTF2, and CTF3 related to safety reporting.

What skills are essential for this role?

Effective communication, organizational, and interpersonal skills are essential, along with the ability to work independently and manage multiple projects.

Will I be required to manage multiple projects simultaneously?

Yes, the ability to manage multiple projects is necessary for this role.

What kind of knowledge is essential for this position?

Knowledge and ability to apply GCP/ICH guidelines, as well as a strong understanding of local regulatory requirements and the clinical trial environment, are essential.

Who will I serve as a Single Point of Contact (SPOC) for?

You will serve as a SPOC for investigative sites, the Site Activation Manager (SAM), the Project Management team, and other relevant departments.

Is there any direct communication with sponsors?

Yes, the role may involve direct contact with sponsors on specific initiatives.

How important is teamwork in this position?

Establishing and maintaining effective working relationships with coworkers, managers, and clients is crucial, making teamwork very important.

Where can I learn more about IQVIA and its services?

You can learn more about IQVIA by visiting their website at https://jobs.iqvia.com.

image

IQVIA

Accelerate innovation for a healthier world.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 86,000 employees, IQVIA conducts operations in more than 100 countries. IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures.

Benefits

  • Medical, dental and vision coverage

  • Employee Assistance Programs

  • Mental health support

  • Flexible work environment

  • Time off for leisure, personal time and corporate holidays

  • Parental leave for birth or adoption

  • Paid leave for other life matters (i.e., illness, bereavement, jury duty, military service, etc.)

  • Retirement and savings plans

  • Commuter benefits

Article & News