Description

<h1>About the role</h1>This position within GCSD is accountable for delivering the clinical operation activities of the study / studies from CSI (Commit to Study Initiation) until study archiving. This involves generating robust and accelerated delivery plans (with a focus on upper quartile performance) and delivering these to target or stretch thresholds and with quality. The GSM role works in consultation with the Global Study Lead (GSL) for end-to-end delivery of the clinical study.The GSM leads the Operational Working Group (in-house studies only) and is member of Central Study Team (CST).<h1>About the responsibilities</h1>Key responsibilities include, but are not limited to:<ul><li>GSM will be the Working Group (WG) Lead for Clinical Operations with accountability for the operational delivery of clinical study/studies to time, quality, and budget, company standards and scientific requirements, supporting decision-making at pace and leading study team to achieve overall study deliverables</li><li>As Operational WG Lead, GSM is accountable for the following deliverables (to be adjusted accordingly for the STOM FSO model):<ul><li>Study Initiation Meeting</li><li>Clinical Study Activity Plan </li><li>Study Delivery Plan</li><li>TMF Quality Strategy Document </li><li>DCT Set Up</li><li>Study Demographic and Diversity Plan </li><li>Vendors Oversight Plan</li><li>Results Dissemination Plan </li><li>Investigator/CRA Meeting Set Up & associated training</li><li>Expected Document List</li><li>Recruitment Tracking</li><li>Budget tracking eTMF filing and Vendor Set Up and Management</li><li>Patient Engagement Activities</li><li>CSDD KOM & template</li><li>Safety Management plan</li><li>Protocol Deviation Management Plan</li><li>eTMF & vendor set-up</li><li>Pharmacy Manual </li></ul></li></ul><ul><li>Supports assessment and selection of FSO vendors</li><li>Accountable for holistic oversight of FSO vendors according to the FSO handbook</li><li>Responsible for assessment and selection of other study vendors under GCSD responsibility in consultation with GSL </li><li>Ensures compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs for assigned studies. understand study contribution to program/submission</li><li>Balances risk/benefit to make decisions based on clear understanding of impact on the study and project</li><li>Proactively and effectively identifies, oversees, and mitigates study risks</li><li>Ensures appropriate stakeholder communication, including study status, expectations, risks and issues</li><li>Accountable to operate within the study budget</li><li>Effectively leads empowered matrix teams</li><li>Implements innovative approaches to study delivery through external facing advances in technology and sciences and encourages others within matrix and line teams to seek innovative perspectives and develop solutions. </li><li>Responsible for operational input into protocol and informed consent form development, and other key study documents.</li><li>Leads and conducts investigator meetings and other study related meetings</li><li>Leads quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies</li><li>Ensures data quality plans and end to end data cleaning is performed instream by the responsible line functions</li><li>Ensures Clinical Study Report is delivered on time and supports GSK’s adherence to local regulatory guidance</li><li>Oversees the activities of the countries participating in the study</li><li>Provides support and coaching (where appropriate) to the SM</li><li>Ambassadors in increasing utilisation of AIML tools, driving automation of manual processes, finding efficiencies and more effective ways of working</li><li>A grade 6 AD-GSM also will have elevated responsibilities such as coaching and mentoring of more junior/less experienced team members and representing GCSD in non-project workstreams or other key initiatives</li></ul><h1>About you</h1><ul><li>Bachelor’s degree: life sciences or related discipline</li><li>The role will require a good understanding of complex clinical development and regulatory processes.</li><li>Experienced Sr-GSM. Strong skills and experience in project management and tools. In-depth knowledge of GCPs and ICH guidelines. At least 5+ years of relevant study management experience in a pharmaceutical/scientific environment.</li><li>In-depth experience in clinical research: study management, monitoring, data management</li><li>Strong skills and experience in project management and tools</li><li>Strong performer / executor of operational tasks with strong skills and experience in study delivery</li><li>Experience of working across multiple types of study designs</li><li>In depth knowledge of GCPs and ICH guidelines</li><li>Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills. </li><li>Demonstrates leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives</li><li>Strong understanding of the clinical study, drug development, sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPs</li><li>Good project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available)</li><li>Able to lead and work within teams and networks across functional and geographical boundaries; leads by example and promotes collaboration, effective communication and leadership in others</li><li>Able to manage competing priorities, performance targets and project initiatives in a global environment</li><li>Operational expertise in risk management and contingency planning</li><li>Applies industry best practices to the design and execution of clinical studies to improve time and cost efficiency</li><li>Demonstrates conceptual, analytical and critical thinking</li><li>Effective at problem solving and conflict resolution</li><li>Ability to manage change and uncertainty</li><li>Ability to delegate tasks</li><li>Demonstrates experience in multicultural settings (to reflect our external customers/clients [health authorities/patients] and diverse environments with respect to dynamics of human interaction (including working with remote teams)</li><li>Demonstrates versatility and ability to adapt to working across multiple TAs</li><li>Ability to think independently, analyse and solve problems systematically and creatively, and to take a risk-based approach.</li></ul>Please take a copy of this job description as it won't be available anymore after the job posting If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.Why GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Global Study Manager

Description

GSK

Pipeline