Beschreibung
We are searching a Clinical Expert in Ethics Submissions, Regulatory, Start-up (RSU) and Maintenance activities for our pharmaceutical client on a freelance basis:Your future tasks:
- Perform Ethics submissions, Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
- 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.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Review, prepare and negotiate site contracts and budgets with sites.
- 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 regulatory and contractual documents for individual sites.
- 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.
- Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning.
- Perform quality control of documents provided by sites.
- May perform Site Selection Visits if a trained monitor.
- May participate in feasibility and/or site identification activities.
You should bring along the following skills:
* In-depth knowledge of clinical systems, procedures, and corporate standards
* Effective communication, organizational, planning and interpersonal skills
* Ability to work independently and to effectively prioritize tasks
* Ability to work on multiple projects
* Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
* Knowledge of applicable regulatory requirements, SOPs and company's Corporate Standards
* Understanding of regulated clinical trial environment and knowledge of drug development process
* Bachelor's Degree in life sciences or a related field and 1 year's clinical research or other relevant experience; or equivalent combination of education, training and experience.
Startdate: January 2015
Duration: 6 month with option for extension
Volume: 40 h / week
Location: office-based/ partly home based
Looking forward to receive you application!
Kind regards,
Stefan Blöchl