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

IQVIA LLC; Frankfurt; Remote; EUR 80,000 - 105,000; Full time

Benefits offered by this job

Competitive salary

Bonus system

Pension

Job summary

IQVIA LLC is seeking a (Sr.) Site Activation Specialist (m/w/d) to support country-level site activation activities in Germany from a home-based location. You will liaise with sites, RSU Team Lead, Clinical Operations, feasibility, and project management to drive regulatory start-up and contract execution.

The role requires GCP/ICH knowledge, German language proficiency at C1, and strong communication with the ability to manage multiple tasks under tight timelines.

Qualifications

• Clinical research experience, preferably in study start-up.
• Knowledge of applicable clinical research regulatory requirements (GCP/ICH).
• Fluent German (C1) and good English required.

Responsibilities

• Serve as single point of contact for investigative sites and project teams.
• Ensure SOPs, timelines and deliverables are met across activities.
• Perform regulatory, start-up and maintenance activities per guidelines.
• Review, prepare and negotiate site contracts and budgets.
• Prepare site regulatory documents and review for completeness.
• Quality control documents provided by sites.
• Submit approval documents to Local Regulatory and Ethics Committees.
• Ensure regulatory approvals, IP release and project deliverables are completed.

Skills

German (C1)

English proficiency

Communication skills

Attention to detail

Multitasking

Education

University degree in life science or related field

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.

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 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.

Benefits

• 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. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.