Study Delivery Lead

Job description

Business Introduction GSK remains committed to achieving bold commercial ambitions for the future. By 2031, we aim to deliver £40 billion in annual sales, leveraging our existing strong performance momentum to significantly increase our positive impact on the health of billions of patients globally. Our Ahead Together strategy is centred on early intervention to prevent and alter the course of disease, thereby protecting people and supporting healthcare systems.Our diverse portfolio consists of vaccines, specialty medicines, and general medicines.Through continuous innovation and a dedicated focus on scientific and technical excellence, we strive to develop and launch new, groundbreaking treatments that address critical health challenges.Position Summary This position within Clinical Matrix Team is accountable for end-to-end study delivery from commit to study initiation until study archiving. This role plans and leads the delivery of single country regulatory mandated interventional studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study proposal. Responsibilities Key responsibilities include, but are not limited to: • Accountability for the operational delivery of clinical study to time, quality, and budget driving decision-making at pace and leading study team to achieve overall study deliverables. • Accountable for holistic oversight of CROs • Accountable for assessment and selection of CRO and other study vendors under Clinical Matrix Team’s responsibility. • Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs for assigned studies; understand study contribution to program/submission. • Proactively and effectively identify, oversee, and mitigate study risks. • Balance risk/benefit to make decisions based on clear understanding of impact on the study and project. • Ensure appropriate stakeholder communication, including study status, expectations, risks and issues. • Preparation of materials for governance and / or financial review cycles. • 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 protocol compliance and continual inspection readiness for assigned studies. • Ensure data quality plans and end to end data cleaning is performed instream by the responsible line functions. • Ensure Clinical Study Report is delivered on time and supports GSK’s adherence to local regulatory guidance. • Identify and communicate resource gaps for assigned studies. • Lead / contribute to ways of working and process improvement initiatives. • Create, maintain oversight plans and oversee clinical studies conducted by CRO • Prepare, track and maintain budgets • Present the project updates to senior leadership Education Requirements (minimum expected) Bachelor’s or Master’s degree in Pharmacy, Medical, Life sciences or related discipline The role will require a good understanding of complex clinical development and regulatory processes. Also, require strong finance and business acumen and experience working in clinical trial management systems. Job Related Experience (minimum requirements) Strong skills and experience in project management and tools in depth knowledge of GCPs and ICH guidelines. Added advantages are: • Extensive clinical development experience and proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment. • Proven ability to collaborate with, influence and manage senior stakeholders both within and outside of the organization. This level of experience is required to provide clinical trials and project management expertise as well as adequate leadership. Other Job-Related Skills • Ability to work independently in a matrix environment with minimal supervision. • Experience in clinical research: study management, monitoring, data management • Strong skills and experience in project management and tools • 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 • Good project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support