Job Description

Site Name: Bengaluru Luxor North Tower Posted Date: Jul 19 2023 This position within GCD is accountable end to end from CSI (Commit to Study Initiation) until study archiving for planning and leading the delivery of interventional, studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study proposal. This involves generating robust and accelerated delivery plans (with a focus on upper quartile performance) and delivering these to target or stretch thresholds. Key Responsibilities : accountability for the operational delivery of clinical study to time, quality, and budget (e.g., 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 Extensive clinical development experience and proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment. This level of experience is required to provide clinical trials and project management expertise as well as adequate leadership. Other Job-Related Skills: 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 operational experience of leading high performing global study teams in clinical trials. Ability to influence and manage stakeholders at all levels of the organization Ability to translate strategic concepts, stakeholder feedback and requirements into cohesive actions for the study team Proactively identify and resolve issues to ensure timely study delivery to quality, timelines, and budget. Excellent leadership skills, influencing and negotiation skills. Demonstrated experience leading in the matrix environment to deliver projects, develop clinical plans and manage change. In-depth knowledge of either study management or data management and knowledge of essential global regulatory guidelines and ICH/GCP. Proven experience working with investigators, external experts and regulatory agencies and oversight of Contract Research Organizations and third-party vendors including realigning with CRO partners when deliverables are at risk, negotiating solutions and leading After Action Reviews to share lessons learned. Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment. Excellent project management skills and budget management skills. Experience of innovative trial design (platform, basket, umbrella, adaptive designs) and decentralised trials (DCT) initiatives. Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary and ability to manage conflict. Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams. Creative thinker able to modernize approach to clinical delivery, leverage external technology and networks to deliver value Ability to articulate and champion key decisions and strategy Ability to define value-driven vision and roadmap for the study Ability to effectively prioritize activities and stakeholder needs Conflict management and negotiation skills Makes timely and complex decisions based on strong rationale Ability to manage change and uncertainty Ability to delegate task. 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