Location
Bangalore | India
Job description
- Key responsibilities include, but are not limited to: accountability for the operational delivery of clinical study to time, quality, and budget (eg, country selection, diversity, patient engagement strategy, recruitment plan, etc), driving decision-making at pace and leading study team to achieve overall study deliverables
- Support assessment and selection of FSO vendors, Accountable for holistic oversight of FSO vendors according to the FSO handbook
- Accountable for assessment and selection of other study vendors under GCD responsibility
- Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs for assigned studies
- understand study contribution to program/submission
- Accountable for translating asset requirements to the study and appropriate communication with the Asset Lead Balance risk/benefit to make decisions based on clear understanding of impact on the study and project
- Proactively and effectively identify, oversee and mitigate study risks
- Ensure appropriate stakeholder communication, including study status, expectations, risks and issues
- Preparation of materials for governance and / or financial review cycles
- Accountable for the study budget Effectively build and lead empowered matrix teams;
- Implement innovative approaches to study delivery through external facing advances in technology and sciences and encourage others within matrix and line teams to seek innovative perspectives and develop solutions
- Decision maker for the innovative solutions (eg DCT, ) to be used at study level Responsible for operational input into protocol and informed consent form development, and other key study documents
- Lead and conduct investigator meetings and other study related meetings; participate in governance meetings as required
- Lead quality efforts to ensure study compliance and continual inspection readiness for assigned studies
- Identify and communicate resource gaps for assigned studies
- Lead / contribute to ways of working and process improvement initiatives
Job Related Experience :
Grade 7: experience in clinical research: study management, monitoring, data management
- Strong skills and experience in project management and tools
- In depth knowledge of GCPs and ICH guidelines
- Experience in clinical research: study management, monitoring, data management
- Strong skills and experience in project management and tools In depth knowledge of GCPs and ICH guidelines
- Solid experience working in teams with a broad range of cultures, including team leadership
- Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
- Excellent understanding of the clinical study, drug development, sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPs
- Good project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available)
- Able to lead and work within teams and networks across functional and geographical boundaries; leads by example and promotes collaboration, effective communication and leadership in others
- Able to set and manage priorities, performance targets and project initiatives in a global environment
- Operational expertise in risk management and contingency planning Applies industry best practices to the design and execution of clinical studies to improve time and cost efficiency
- Demonstrates conceptual, analytical and strategic thinking
- Effective at problem solving and conflict resolution
- Ability to manage change and uncertainty
- Ability to delegate tasks
Job tags
Salary
