Job Description

Site Name: Bengaluru Luxor North Tower Posted Date: Jan 17 2024 Job Purpose : Study Manager (SM) is responsible for end-to-end operational study delivery, including development and review of study documents, completion and maintenance of internal systems/databases/tracking tools and project plans, vendor management, cooperation with Local Operating Companies (LOCs) and other internal functions. SM executes trial management activities, as delegated by Study Delivery Lead (SDL) for in-house and outsourced studies across all phases and therapy areas, in accordance with standard operating procedures, clinical operational plans, regulatory requirements and Good Clinical Practice Working in close partnership with SDL, SM plays a key role in successful study delivery, providing subject matter expertise across key processes and systems through the life cycle of the study. SDMs should be able to apply their judgement and take a risk-based approach to make independent decisions with minimal guidance from SDL. SDM role is implemented to have a broader impact on the business, by driving continuous improvement initiatives within their remit of expertise, sharing best practices across the business, with a focus on increasing efficiency of operational delivery of studies. Key Responsibilities: Delivery of study to plan, including managing the study team\'s communication/meetings, tracking progress and the monitoring/assessment of risks to timeliness or quality of study delivery Preparation and update of study documents and study plans (incl CSAP), including study protocol, Monitoring Plans, Vendor Management Plans, Protocol Deviation Management Plans, Risk Management Plans, Communication Plans etc. Local Operating Companies liaison / oversight - including tracking of recruitment progress, data completeness and compliance, local budget oversight, protocol deviations oversight, supplies\' availability, regulatory approvals and import license status Vendor management & CRO oversight - agreeing on study-specific setup requirements, ensuring continued monitoring of agreed delegated activities Supporting SDL in quality and data oversight to ensure inspection/audit readiness, including oversight of eTMF completeness Setting up and maintaining clinical trial management systems and tracking tools that ensure quality, consistency and integration of study data, following up on discrepancies if needed Risk management - contribution to maintenance of a comprehensive risk management plan and risk tracking Clinical supplies and recruitment materials management - having oversight on study level supplies availability, recognizing and communicating issues to continuity of supplies, proposing solutions as appropriate Coordination of the study budget - including support to contract management for vendors, managing expenses, tracking updates, checking consistency between systems and agreements and escalating issues Providing input to develop study specific processes and procedures, adhering to standardization and dissemination of best practices Providing support to departmental initiatives and objectives, including for example support, training/mentoring as required Previous Experience Required : Graduate or Bachelor level with at least 3+ years of relevant working experience in pharmaceutical / scientific environment. Scientific background an asset. Knowledge of clinical trials (including ICH-GCP) is a must. Expert in clinical trial delivery, including processes, regulations, operational best practices, industry standards. Well familiar with key systems used in clinical trial delivery. Experience of using Trial Master File industry accepted standard Strong project management skills (preferably with analytical/financial skills). Project management certification is a plus 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. 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