This role involves managing regulatory processes and site startup activities, ensuring compliance and accuracy while supporting project timelines and fostering communication among teams and stakeholders.
Anforderungen
- •Bachelor's Degree in life sciences
- •3 years' clinical research experience
- •Good negotiating skills
- •Strong communication skills
- •Knowledge of GCP/ICH guidelines
- •Knowledge of regulatory requirements
- •Understanding of regulated clinical trials
- •Knowledge of drug development process
Deine Aufgaben
- •Serve as Single Point of Contact for investigative sites.
- •Ensure compliance with standard operating procedures.
- •Perform start-up and site activation activities.
- •Distribute completed documents to sites and team members.
- •Prepare and review site regulatory documents for accuracy.
- •Maintain internal systems and databases with project information.
- •Provide feedback on site performance metrics to management.
- •Establish and agree on project planning and timelines.
- •Implement monitoring measures and contingency plans.
- •Inform team of completion of regulatory and contractual documents.
- •Track and follow up on document approvals and executions.
- •Provide local expertise to teams during project planning.
- •Perform quality control of documents from sites.
- •Interact directly with sponsors on specific initiatives.
Original Beschreibung
# Regulatory and Start Up Specialist - Switzerland
**Basel, Switzerland** | **Full time**
**Job Overview**
Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.
**Home based, requiring German language fluency.**
**Essential Functions**
* Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
* Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
* Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
* 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.
* 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, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
* Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
* Perform quality control of documents provided by sites.
* May have direct contact with sponsors on specific initiatives.
**Qualifications**
**Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.**
* Good negotiating and communication skills with ability to challenge, if applicable.
* Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
* Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.
* Understanding of regulated clinical trial environment and knowledge of drug development process.