South San Francisco, CA
3 year contract - Huge opportunity to make a great impression at one of the leading Biotech companies in the world!
*Multiple level of positions open! Depending on local needs the responsibilities of this role can be covered by Clinical Study Manager (CSM) or Country Study Specialist CSS roles (decision maker local Country Head or Medical Director).
- University Degree preferably in a medical/science-related field.
- Prior work experience demonstrating knowledge and understanding of clinical trials.
- Demonstrated knowledge and understanding of ICH-GCP, the regulatory, ethics and contractual requirements for starting clinical trials in relevant country.
The Study Start-up (SSU) Specialist functions as a subject matter expert on all SSU-related activities in the country/region, oversees and leads SSU activities in collaboration with other clinical research stakeholders and serves as a leader for local/global SSU process improvements and patient recruitment strategies.
-Condensed job description-
Study Start-up Coordination and Execution:
- Coordinates, guides and assists with all start up activities prior to site activation, including but not limited to:
- Site Informed Consent Form (ICF) localization and guidance in line with regulatory / health authority requirements
- Ethics Committee information, meeting dates & costs
- Ethics applications & associated online systems
- Ethics & Governance submission processes
- Clinical Trial Health Authority application and regulatory submission process
- Contracts & Indemnity request process
- Localize global Informed Consent Form (ICF) with country requirements
- Other materials and documentation used by the study requiring local governance approval
- Maintains up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation
- Review, analyze and collate metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation
- Ensures all start up information & requirements are kept up to date in a central repository for project teams
- Assists with label preparation and approval (local label representative) for studies in collaboration with local regulatory department
- Tracks metrics and study start-up timelines to identify trends and opportunities for improvement
- Demonstrated competence in analysis, planning and problem solving.
- Excellent communications skills including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution.
- Ability to present clear messages from complex information/data to all levels in the organization in both written and spoken English.
- Experience working as part of a team with a proven ability to make an active contribution to the team's performance and teamwork.
- Able to make effective decisions, self-motivated, assertive, and displays initiative.
- Proven project management and organizational skills and the ability to prioritize and manage multiple tasks with flexibility.
- Demonstrated computer literacy, usage of MS Office software, web-based systems and databases.