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

IQVIA LLC; Deutschland; Remote; EUR 80,000 - 110,000; Full time

Benefits offered by this job

Flexible schedule

Home-office

Pension and more

Job summary

IQVIA LLC is seeking a Sr. Site Activation Specialist (m/w/d) to lead country-level site activation activities from a home-based position in Germany.

You will ensure regulatory compliance, manage site contracts and budgets, and coordinate with Clinical Operations, Feasibility, and Project Management teams. Required is a life science degree or related discipline with clinical research experience, strong German language skills (C1) and excellent English, and a track record in start-up activities

Qualifications

• University degree in life science or related field or apprenticeship in health care or paralegal work.
• Clinical research experience with study start-up is preferred.
• Knowledge of GCP/ICH regulations.
• German (C1) and English language proficiency.

Responsibilities

• Serve as single point of contact for investigative sites and cross-functional teams.
• Perform regulatory start-up and maintenance activities per regulations and SOPs.
• Review, prepare and negotiate site contracts and budgets.
• Prepare site regulatory documents for ethics committees and IP releases.
• Track documents and ensure project timelines and internal systems are updated.
• Support project planning and contingency planning to maintain efficiency.

Skills

German language (C1)

English language

Communication skills

Education

Life science degree 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. **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! **Please apply with your English CV and motivation letter.**