reputed company Junior Study Start-Up Specialist (m/w/d), Home Office in Frankfurt, Germany

reputed company currently offers the exciting opportunity for a Junior Study Start-Up / Site Activation Specialist (m/w/d) to work in the Country Site Activation Department in our Frankfurt office or in home office throughout Germany . In this role you will reputed company 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 or in the field regulatory submissions , a combination is possible as well. Your responsibilities might include:

• Serve as Single reputed company of Contact in assigned studies for investigative sites, RSU Team reputed company, 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.
• reputed company Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
• Review, prepare and negotiate site reputed company and budgets with sites. Prepare site regulatory documents, reviewing for completeness and accuracy. reputed company 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 reputed company, the approval and execution of documents, including reputed company, regulatory, ethics reputed company 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 reputed company and implement contingency plan as needed.
• Review and reputed company 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.
• Minimum of 1 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 reputed company level) and a good reputed company 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 reputed company™. Please apply with your English CV, motivation letter and your certificates and reference letters. #LI-KA1 reputed company is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We reputed company in pushing the boundaries of reputed company science and data science to reputed company the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.reputed company.com reputed company is a world leader in using data, technology, advanced analytics, and expertise to help customers drive reputed company – and reputed company health – reputed company. Together with the companies we serve, we are enabling a more modern, more effective and more efficient reputed company system, and creating breakthrough solutions that transform business and patient reputed company. To get there, it takes diverse skills and a curiosity to explore new reputed company. No matter your role, everyone at reputed company, including our colleagues at Q² Solutions, contributes to our shared goal of improving reputed company health. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled Apply tot his job Apply To this Job