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Regulatory and Start Up Specialist 2 Germany (m/w/d) Home Based

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IQVIA

26d ago

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

AI generated summary

  • You need a Bachelor’s in life sciences, 3 years of clinical research experience, knowledge of GCP/ICH, local regulations, and an understanding of the drug development process.
  • You will manage site activation, ensure compliance with SOPs, prepare regulatory documents, track approvals, and provide local expertise to project teams while maintaining quality and timelines.

Requirements

  • Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research experience.
  • In-depth knowledge of clinical systems, procedures, and corporate standards.
  • 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.

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

Is this position a remote job?

Yes, this is a home-based role.

What languages are required for this job?

Fluency in German is required for this position.

What is the main responsibility of the Regulatory and Start Up Specialist 2?

The main responsibility is to perform tasks associated with Site Activation activities in accordance with local and international regulations, SOPs, and project requirements.

What qualifications are needed for this role?

A Bachelor's Degree in life sciences or a related field and 3 years of clinical research experience are required.

What kind of experience is preferred for this job?

In-depth knowledge of clinical systems, procedures, and corporate standards, as well as experience with GCP/ICH and applicable regulatory guidelines, are preferred.

Will the specialist interact with sponsors?

Yes, the specialist may have direct contact with sponsors on specific initiatives.

What type of documents will the specialist be responsible for preparing?

The specialist will prepare site regulatory documents and review them for completeness and accuracy.

Is previous experience in a regulated clinical trial environment necessary?

Yes, an understanding of the regulated clinical trial environment and knowledge of the drug development process is essential.

Are there opportunities for providing feedback on site performance metrics?

Yes, the specialist will review and provide feedback to management on site performance metrics.

Will the Regulatory and Start Up Specialist be involved in project planning?

Yes, the specialist will review, establish, and agree on project planning and project timelines.

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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

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