***Mitarbeiter Klinische Forschung/Regulatory Start-up Specialists (Befristet/FTC)***
We currently have exciting job opportunities as Regulatory Start-up Specialist (f/m) to work in our Regulatory & Start-up Department in Neu-Isenburg or Freiburg/Br. The positons will be on a fixed-term contract (1 year).
Perform tasks associated with Regulatory, Start-up (RSU) and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May participate in feasibility and/or site identification activities.
- Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and CST. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines.
- Review, prepare and negotiate site contracts and budgets with sites.
- Distribute completed documents to sites and internal project team members.
- Prepare site regulatory 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.
- 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.
- Perform quality control of documents provided by sites.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Effective communication, organizational and planning skills
- Ability to work independently and to effectively prioritize tasks
- Interested in regulatory and/or legal aspects
- Ability to work on multiple projects
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s Degree or apprenticeship in commercial, admin, legal or science.
- Fluent languages skills in German and good command of English.
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