location_onLondon, UK
watch_later Posted: Feb 22, 2024
Skills Required
Nice To Have skills
Job Description
Job Overview:
- 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.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Perform admissions of regulatory documents.
- 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.
- Perform quality control of documents provided by sites.
- Inform team members of completion of regulatory and contractual documents for individual sites.
Requirements:
- Bachelor’s Degree in life sciences or a related field
- 3 years clinical research experience, including 1 year experience in a leadership capacity or equivalent combination of education, training, and experience.
- In-depth knowledge of clinical systems, procedures, and corporate standards.
- 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.