Job Description

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. \xef\x82\xb7 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 \xef\x82\xb7 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. \xef\x82\xb7 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\xe2\x80\x99s communication/meetings, tracking progress and the monitoring/assessment of risks to timeliness or quality of study delivery \xe2\x80\xa2 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. \xe2\x80\xa2 Local Operating Companies liaison / oversight \xe2\x80\x93 including tracking of recruitment progress, data completeness and compliance, local budget oversight, protocol deviations oversight, supplies\xe2\x80\x99 availability, regulatory approvals and import license status \xe2\x80\xa2 Vendor management & CRO oversight \xe2\x80\x93 agreeing on study-specific setup requirements, ensuring continued monitoring of agreed delegated activities \xe2\x80\xa2 Supporting SDL in quality and data oversight to ensure inspection/audit readiness, including oversight of eTMF completeness \xe2\x80\xa2 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 \xe2\x80\xa2 Risk management \xe2\x80\x93 contribution to maintenance of a comprehensive risk management plan and risk tracking \xe2\x80\xa2 Clinical supplies and recruitment materials management \xe2\x80\x93 having oversight on study level supplies availability, recognizing and communicating issues to continuity of supplies, proposing solutions as appropriate \xe2\x80\xa2 Coordination of the study budget \xe2\x80\x93 including support to contract management for vendors, managing expenses, tracking updates, checking consistency between systems and agreements and escalating issues \xe2\x80\xa2 Providing input to develop study specific processes and procedures, adhering to standardization and dissemination of best practices \xe2\x80\xa2 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 \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 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. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We\xe2\x80\x99re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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