Study Start-up Specialist II (上海)
Parexel · Shanghai
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Key Accountabilities:
SSU 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 (“EC”) 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. For global studies, localize global ICF with country requirements. Local sample application and permit submission processes
- Maintains up to date knowledge, ensuring adherence and compliance with local regulatory requirements and associated documentation
- Reviews, analyzes, and collates 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 both global and local study teams
- Assists with label preparation and approval (local label representative) for studies in collaboration with local regulatory department
- Tracks metrics and SSU timelines to identify trends and opportunities for improvement
Relationship management
- Liaises and collaborates with relevant authorities/bodies to further enhance clinical trial processes, government policies/laws, via innovative approaches
- Maintains current, and awareness of changes in, startup processes across government, hospital & industry & liaises with stakeholders to resolve any SSU issues
- Proactively responds to information survey requests by government/ industry bodies
- Provides continuous and proactive communication with ECs/hospital administration/industry bodies to obtain accurate and up to date information on clinical trial status and activities
- Maintains communication with local legal/regulatory/clinical operation to ensure input is sought and all internal/external requirements are met
- Provides guidance to Country Study Managers (CSMs) and Country Study Specialist (CSS) on regulatory/ethics, tracks & drives site activations by regular review and monitoring status of submissions/ activations
- Collaborates with vendor management and procurement to provide input as required into vendor identification, selection, and Request for Information (RFI)/ Request for Proposal (RFP) process
- Liaises and shares best practices with other SSU within the region/organization
New Site Identification
- Assists with identification and tracking of new sites in collaboration with CSMs
- Performs/coordinates site level feasibility activities including evaluation of patient population and final site selection
Contracts/ Budget
- Negotiates contracts and study budgets with sites during the SSU phase to ensure finalization
- Provides local fee structures and budgetary advice as required and ensure compliance to Fair Market Value (FMV) in the country
- Collaborates with CSMs to maintain data to ensure FMV
- Liaises with management/CSMs to implement budget cost containment and implement contingencies as required
Compliance with Parexel standards
- Complies with required training curriculum
- Completes timesheets accurately as required
- Submits expense reports as required
- Updates CV as required
- Maintains a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements
Skills:
- Demonstrated competence in analysis, planning and problem solving.
- Excellent communications 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.
- Ability to make effective decisions.
- Proven project management and organizational skills and the ability to prioritize and manage multiple tasks with flexibility.
- Demonstrated teamwork and ability to make an active contribution to team performance.
- Demonstrated computer literacy, to usage of MS Office software, web-based systems, and databases.
- A flexible attitude with respect to work assignments and new learning.
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
- Willingness to work in a matrix environment and to value the importance of teamwork.
Knowledge and Experience:
- >1.5 years of proved SSU experience in clinical trials, experience in global company is preferred.
- Demonstrated knowledge and understanding of ICH-GCP, the regulatory, ethics and contractual requirements for starting clinical trials in China.
- Achieved a satisfactory level of technical, functional, and/or professional skill/knowledge in position – related areas; keeps up with current developments and trends in areas of expertise; leverages expert knowledge to accomplish results.
Education:
- University Degree or equivalent preferably in a medical/science-related field.