Sr.) Site Activation Specialist; m​/w​/d

Stellenbezeichnung: (Sr.) Site Activation Specialist (m/w/d)
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.*
*