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Are you looking for Life Sciences Jobs, GSK Careers, or Clinical Research Jobs in India? GSK is hiring a Study Delivery Lead for its Clinical Matrix Team in Worli, Mumbai. This full-time opportunity is ideal for Pharmacy, Medical, and Life Sciences professionals with clinical trial management experience who are looking to lead global clinical studies while contributing to innovative healthcare solutions.
About GSK
GSK is a global biopharmaceutical company dedicated to uniting science, technology, and talent to get ahead of disease together. Through its Ahead Together strategy, GSK aims to improve the health of billions of people worldwide by focusing on vaccines, speciality medicines, and general medicines. The company is committed to innovation, scientific excellence, and developing breakthrough treatments that address critical healthcare challenges while fostering an inclusive and collaborative work environment.
Job Details
- Category: Medical and Clinical
- Job ID: 444106
- Job Type: Full Time
- Work Mode: On-Site
Key Responsibilities
- Accountable for the operational delivery of clinical study to time, quality, and budget, driving decision-making at pace and leading the 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 a clear understanding of the 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 are performed in-stream 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.
Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Medical, Life Sciences, or related discipline.
- Good understanding of complex clinical development and regulatory processes.
- Strong finance and business acumen.
- Experience working in clinical trial management systems.
Experience Required
- Strong skills and experience in project management and tools.
- In-depth knowledge of GCPs and ICH guidelines.
- Extensive clinical development experience.
- 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 within and outside the organisation.
- Experience providing clinical trials and project management expertise, along with leadership.
Skills Needed
- Ability to work independently in a matrix environment with minimal supervision.
- Experience in clinical research, study management, monitoring, and data management.
- Strong project management skills and experience with associated tools.
- Experience leading multicultural teams.
- Excellent leadership, communication, influencing, and negotiation skills.
- Strong understanding of clinical studies, drug development, sample management, and quality requirements.
- Budget, timeline, scope, and resource planning expertise.
- Ability to lead across functional and geographical boundaries.
- Ability to manage priorities and project initiatives in a global environment.
- Knowledge of industry best practices to improve study time and cost efficiency.
- Strong analytical, conceptual, and strategic thinking.
- Effective problem-solving and conflict resolution skills.
- Ability to manage change and uncertainty.
- Experience leading projects in a matrix environment.
- Expertise in identifying issues impacting clinical programs and contributing to cross-functional solutions.
- Ability to communicate strategies and present project updates to senior leadership.
- Extensive experience working with investigators, regulatory agencies, CROs, and third-party vendors.
