Study Start-Up Specialist (m/w/d), home-based in Germany

IQVIA currently offers the exciting opportunity for a junior or experienced Study Start-Up / Site Activation Specialist (m/w/d) to work in the Country Site Activation Department in our Frankfurt office or home-based throughout 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.

You will be specializing in the field contracting and budget negotiations.

Your responsibilities might include:

• Under general supervision, serve as Single Point of Contact in assigned studies for investigative sites, Site Activation Manager, Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), quality of designated deliverables and project timelines.
• Perform feasibility, site identification, 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 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 feasibility, site ID, regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, questionnaires, Confidential Disclosure Agreement (CDA) / Site Investigator File (SIF), regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to Site Activation Manager 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.

Qualifications:

• University Degree inlife science or other scientific discipline or apprenticeship in health care or as legal secretary / paralegal
• Minimum of 3 years of 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!

We invite you to join IQVIA™.

Please apply with your English CV, motivation letter and your certificates and reference letters.

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