(Sr.) Site Activation Specialist (m/w/d)

IQVIA Argentina; Frankfurt; Remote; EUR 55,000 - 90,000; Full time

Benefits offered by this job

Flexible work schedule

Home office

Career development

Job summary

IQVIA in Germany is seeking a Sr. Site Activation Specialist to work home-based within Germany.

You will perform country-level site activation activities for clinical research in compliance with GCP/ICH, SOPs, and project requirements. As the Single Point of Contact, you will coordinate with investigative sites, regulatory bodies, and project teams; negotiate site contracts, prepare regulatory documents, and monitor timelines and quality across studies.

Qualifications

• University degree in life science or related field
• Clinical research experience, preferably in study start-up
• Knowledge of GCP/ICH regulatory requirements
• Fluent German (C1) and good English proficiency

Responsibilities

• Serve as Single Point of Contact in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and the client.
• Ensure adherence to SOPs, work instructions, quality of designated deliverables and to project timelines.
• Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
• Review, prepare and negotiate site contracts and budgets with sites. Prepare site regulatory documents, reviewing for completeness and accuracy. Perform quality control of documents provided by sites.
• Complete and submit approval request documents to Local Regulatory and Ethical Committees. Ensure regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.
• Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics ICF and IP Release documents, in line with project timelines.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
• Review and provide feedback to management on site performance metrics.

Skills

Regulatory knowledge

SOP adherence

Project coordination

German language (C1)

English language

Education

University degree in life sciences

Apprenticeship in health care

Paralegal background

Job description

External Job Description

IQVIA currently offers the exciting opportunity for a(Sr.) Site Activation Specialist (m/w/d) to work in the Country Site Activation Department home-based within Germany.

In this role you will perform tasks at a country level associated with clinical research site activation activities in accordance with applicable local and/or international regulations, standard operating procedures, project requirements and contractual/budgetary guidelines.

Your responsibilities might include:

• Serve as Single Point of Contact in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and the client.
• Ensure adherence to standard operating procedures (SOPs), work instructions, quality of designated deliverables and to project timelines.
• Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
• Review, prepare and negotiate site contracts and budgets with sites. Prepare site regulatory documents, reviewing for completeness and accuracy. Perform quality control of documents provided by sites.
• Complete and submit approval request documents to Local Regulatory and Ethical Committees. Ensure regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.
• Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics ICF and IP Release documents, in line with project timelines.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
• Review and provide feedback to management on site performance metrics.

Qualifications:

• University Degree in life science or other scientific discipline or apprenticeship in health care or as legal secretary / paralegal.
• Clinical research experience, preferable in study start-up, alternatively an equivalent combination of education, training and experience.
• Knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Fluent language skills in German (on at least C1 level) and a good command of English.
• Strong written and verbal communication skills.
• Attention to detail and ability to work on multiple tasks and prioritize.

What you can expect:

• Supportive leaders, mentors and teams.
• Resources that promote your career growth.
• Dynamic work environments that expose you to new experiences.
• Flexible working schedule and home-office.
• Competitive salary, bonus system, pension and more.

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

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.