Job Description

Site Name: Bengaluru Luxor North Tower
Posted Date: Aug 23 2022

Ready to help shape the future of healthcare?
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. 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 Breadth/Scope of Ac

Why you?

Basic Qualifications:

• Graduate or Bachelor level with at least 5+ years of relevant working experience in pharmaceutical / scientific environment.
• Scientific background is 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

At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

• LI-GSK

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 organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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