Posted Date: Apr 12 2024
Job Purpose
To manages site start up(SSU) including DB set up
To manages all aspects of long term and/or multi-centers research projects including plan, coordinate, conduct, outsourcing, and risk management in particular accordance with written standards and local legislation to commit the license condition and regulatory requirements.
Key Responsibilities
• Responsible for SSU and initial set up including DB, EDC set up(DVP validation, EDC testing align with CRF design etc.)
• Responsible for regulatory commitment study with complete compliance in entire project progress, specifically data collection, analysis and report writing in line with regulatory requirement.
• Ability to develop and manage the key study document aligned with scientific and evidence perspective accordance with written standards and mandatory legislation
• To have business ownership of relevant venders by conducting oversight and risk management aligned with GSK ICF(internal control framework) model
• Collaborate with team and key stakeholders
• Work on any assignment as directed.
Requirements
• Minimum BS in science or related medical, bio science, Pharmaceuticals, nursing, biology in BS
• 2+years related experience of clinical study operation, EDC set up
• Maintain a high level of integrity while balancing multiple priorities and responsibilities.
• Attention to detail with strategic organization with strong ownership
• Experience working in Pharma/Bio/CRO environment that requires working with practical operators to better understand requirements.
• Focused on solution thinking and agile in learning new systems and processes
• Motivated and interested in learning new study, scientific discussion and research
• Ability to communicate both verbally and in writing with all levels both insider and outsider of organization.
• The ability to clearly write technical documentation as necessitated by regulatory agencies on internal policy
• Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
• Sense of urgency, flexibility, and accountability.
• Must be a committed team player prepared to work in and embrace a team-based culture.
• Ability to find improvement and efficient applications of the data collection system.
• Ability and motivation to work in new applications, business processes.
• Provide expertise necessary to train site personnel.
*LI-GSK
Why Us?
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it¡¯s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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