SSU
Taipei, Taipei City, Taiwan Job ID R0000022224 Category Clinical TrialsAbout this Role
The Study Start-Up Manager (SSU Manager) is responsible at country level for managing and conducting start-up activities in compliance with the CLIENT procedures, documents, local and international guidelines such as ICH – GCP and relevant regulations.
The SSU Manager will prepare, review, track and manage site regulatory documentation at country and site level, and will maintain, review and report on site performance metrics.
The SSU manager works in close collaboration with the CRAs and the Local Study Team/Local Study Associate Director to ensure that study start-up activities and milestones are achieved in a timely and efficient manner.
SSU Manager might have different internal titles based on the experience level (SSU Manager, Senior SSU Manager). The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The Director, Country Head may assign this internal title after confirmation with Senior Director, Cluster Head / Executive Director, Regional Head.
- Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
- Accountable for study start-up and regulatory maintenance being in charge with collection, preparation, review and tracking of documents for the application process;
- Accountable for submission of proper application/documents to Regulatory Authorities and/or IEC/IRB during start-up period.
- Actively participates in Local Study Team (LST) meetings.
- Update CTMS and other systems with data from study sites as per required timelines during the start-up period.
- Follow up on outstanding actions with study sites during start-up period to ensure resolution in a timely manner.
- Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, CLIENT SOPs and local requirements. Support QC checks performed by LSAD or delegate to ensure that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with CLIENT SOPs.
- Provide regular information to Line Managers at country level on study and planned study milestones/key issues during the start-up period.
- Provide feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
- Support SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.
Upon local decision, additional responsibilities may include*:
- Prepare, review and negotiate contracts with investigational sites being the primary point of contact for investigational sites to ensure the contracts are fully executed
- Support site selection process by identifying and assessing potential sites/investigators
- Accountable for continuing submission of proper application/documents to IEC/IRB and to Regulatory Authorities for the duration of the study.
- Assist in initial forecasting for budget, study materials and drug supplies. Plan applicable local drug activities (local purchase or reimbursement
Education, Qualifications, Skills and Experience
- Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
- Good knowledge of international guidelines ICH-GCP as well as relevant local regulations, basic knowledge of GMP/GDP
- Basic understanding of drug development process
- Good collaboration and interpersonal skills.
- Good verbal and written communication skills.
- Excellent attention to details.
- Excellent understanding of Clinical Study Management and study start-up
- Good negotiation skills.
- Good ability to learn and to adapt to work with IT systems.
- Good medical knowledge and ability to learn relevant CLIENT Therapeutic Areas.
- Integrity and high ethical standards.
- Good analytical and problem-solving skills.
- Good financial management skills.
- Basic change management skills.
- Good intercultural awareness.
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
- Good analytical and problem-solving skills.
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
- Good cultural awareness.
- Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
Key stakeholders and relationships
- Local Study Teams and LSADs
- Global Study Team including SMM Lead (STOM)
- Line manager/ local SMM LT team
- Clinical Quality Associate Director
- Local Medical Teams: Medical Affairs and MSLs
- Enablement functions
- Local Regulatory Affairs
- Local Patient Safety
- Investigators and site personnel
- Study related vendors
- Inspectors
- Regulatory Authority
- EC/IRB
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