Description
IQVIA currently offers the exciting opportunity for a (Sr.) Site Activation Specialist 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.