Provides essential operational support to Clinical Studies:
o Updates knowledge on related regulatory requirements, ensures adherence and
compliance with local regulations and internal procedures.
o Executes all start-up activities prior to site activation on assigned studies, according to
Roche standards and aligned with study/project requirements and timelines.
o Supports operational aspects for implementation of clinical study activities from study
start up through database lock, ensuring Roche quality and safety standards,
regulations, timelines and budget commitments are met.
Ensures appropriate tracking systems and tools are in place to ensure compliance to
regulations, internal policies, ICH-GCP and GPP (Good Pharmacoepidemiology Practice) when
Supports contract preparation and negotiations with all stakeholders.
Maintains and analyses study start-up data (metrics) on assigned studies, ensuring optimal
efficiency to reduce start-up timelines and identify opportunities for continuous improvement.
Partners with Local Study Teams to provide guidance on regulatory/ethics requirements, to
track and drive site activations and trial amendments submissions, by regularly reviewing and
monitoring status of submissions/activations.
Support to local affiliate study level for audit / inspection action plan activities.
Maintains effective and ongoing communication with CSM; supports communication with local study teams and to sites as required.
Develops operational elements at a Country Level; supports study communication plan, budget and payment plan (based on country financial plan) and other local requirements.
Provides proactive support actively involving respective internal and external LST members.
- University Degree in a medical/science-related field.
- Postgraduate education will be highly valued (Master's Degree, Specialization).
- Extensive knowledge of ICH/GCP. GPP guidelines knowledge highly valuable.
- Prior work experience in clinical trials monitoring, at least 4 years.
- Demonstrated ability to interact with different stakeholders of the research
- Experience on influencing and negotiating at all levels to achieve team delivery.
- High level of English.
- Demonstrated computer literacy, usage of MS Office software, web-based systems
- and databases.
- Ability to travel domestically and internationally.
- Building Customer Loyalty
- Technical & Professional Knowledge & Skills
- Decision Making
- Building Partnerships, Earning Trust
- Influencing & Communication
- Planning & Organizing