City : 100 Milverton Drive

Category : Other

Industry : Healthcare

Employer : GSK

Job Purpose:

• The Study Delivery Lead (SDL) is the Project Manager of a study. As such, the SDL is accountable to ensure that the study team is planning and executing the study according to time, budget and quality and as defined in the Development Plans (Clinical, Epidemiology, Global and Local studies), in the study management plan, in the study protocol, and in adherence with ICH-GCP guidelines, GSK Vaccines control documents and within regulatory requirements.
• The SDL is the single point of contact for the integrated operational planning, design, operational feasibility and delivery of their study(ies) from commit to study idea until publication.
• The scope of work includes leadership, study management, oversight and project management of both global and in-country activities, as well as authorship of some study documents.
• The SDL works closely with the Clinical Research Development Leaders (CRDL), Epidemiologist (central and regional) and GSK Country Medical Directors (for Local studies), who are responsible for the medical and scientific aspects, scientific design of the protocol and scientific outputs including data interpretation and reporting.

Details (Your Responsibilities):

The Study Delivery Lead ensures the translation of scientific objectives in the Study Management Plan. By using integrated processes, tools and measures the SDL ensures the study oversight, delivery of the study on time, according budget and with quality, using a risk-based approach methodology:

• Develops a study management plan including forecast, detailed schedule, budget and Quality Management Plan
• Ensures a study-level risk assessment is performed, ensures that identified risks are appropriately mitigated.
  • Develops and maintains Study Risks Management Plan
• Ensures development and management of Study Quality Management Plan and conduct related quality assessment, endorses proposal for site assessments/audits, analyze and follow up assessment reports
• Prepares monitoring and communication plans (including definition of study essential data for adaptive monitoring)
• Ensures issue escalation and management up to resolution. 
• The SDL communicates progress and escalates issues to the Project Delivery Lead when appropriate
• Defines resource requirements and ensure appropriate resourcing (including outsourcing)
• Tracks delivery to time, cost and quality, ensures maintenance of standard tools such as iPlan, eTrack and SAP.
• Sets up the Study Dashboard to facilitate the integrated study oversight. Each Study Core Team member has his own accountability to ensure control and monitoring of his departmental plans.
• Accountable for the study budget
• Ensures appropriate documentation of Oversight is available in the TMF at all times, ensure completion of Trial Master File (collect of Essentials doc…), ensure archiving for paper file...

• In partnership with the Clinical Research Development Lead (CRDL), Epidemiologist, Country Medical Directors (for local studies), co-ordinates all members of the study network to ensure the appropriate experts (both central and local, operational and medical/scientific) are involved at appropriate stages and outputs are delivered on time
• Leads a multifunctional team to ensure study Oversight, study delivery and takes operational decisions at study level (will refer to Project Delivery Lead as needed). Each Study Core Team member is responsible to have the oversight of the activities pertaining to his department as well as oversight related to vendors
• Ensures appropriate study oversight including study kick off meeting(s), regular TC with LOC/CRO, review protocol deviations, escalation process and ensure appropriate follow-up actions are taken
• Develops and maintains, with the Study Core team, the study dashboard including key risk indicators (KRIs), key performance indicators (KPIs) and other study related reports / tools
• Communicates progress to Project Delivery Lead and study team
• Leads and oversees operational activities in study design and study execution including
  • Inputs to concept protocol and protocol development to ensure optimal operational design
  • Accountable to ensure that the study feasibility process and the country/ies allocation are optimal in regards of the project strategy. The Strategic Clinical Planning Manager has the accountability of the feasibility process
  • Accountable to ensure that the study execution health check is the most optimal in regards of the project strategy. The Strategic Clinical Planning Manager has the accountability to coordinate the study execution health check meeting
• Ensures functional strategy and plans are developed, maintained and executed including clinical supplies, sample management, data management, document management and quality.
• Participates in country and site selection, with reference to pre-selection decisions made at Development Plans level
• In coordination with the study core team, ensures that appropriate documents are available to regional teams for timely submission to Ethics Committees and/or Regulatory Authorities according to local requirements
• Ensures appropriate training of country staff and sites on protocol and project specific matters - Prepare/deliver monitors meeting (when applicable)
• Develops and ensures on-time execution of supportive documents, plans and manuals including the monitoring plan, study procedures manuals, core operational packages for submission and for countries
• Responsible for vendor management activities including selection and contract development when outsourced activities are owned by the SDL
• Develops and follows the most efficient operating model for collaborative studies, to manage appropriately the risks linked to supported/collaborative studies and has experience and skills to manage all associated requirements – Same for the management and oversight of outsourced studies (including RFP/Bid defense and contract management)
• Provides input to the clinical study report / module appendix
• Ensures Sign-off essential study documents
• Ensures collection and review of Protocol deviations and ensure review & analysis of Data Quality Escalate as appropriate.
• Responsible for 1-4 trials of average design and protocol complexity (can be more for Supported or very simple studies)
• Maintains expertise in GCP and in clinical study management methodology and support process improvement initiatives and shares best practices within the SDL team and beyond

 Why you?

Basic Qualifications:

• Bachelor’s degree in the areas of General Science or Life/Health Science
• 6 years of experience in managing clinical research studies, clinical operations or equivalent
• Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives 
• Demonstrates an excellent understanding of the clinical study, drug development, sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPs
• Good project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available)
• 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
• Able to set and manage priorities, performance targets and project initiatives in a global environment
• Operational expertise in risk management and contingency planning
• Experience applying industry best practices to the design and execution of clinical studies to improve time and cost efficiency
• Skilled at being a role model in line with GSK Vaccines core values and Expectations
• Ability to understand the impact of technology on studies and to use and develop computer skills while making appropriate use of GSK Vaccines systems/software
• Demonstrates conceptual, analytical and strategic thinking
• Effective at problem solving and conflict resolution
• Possesses excellent English language written and verbal communication skills in addition to proven negotiation skills.

Preferred Qualifications:

• Master, Post graduate degree in a life science field (Pharmacy, Chemistry, Bio Engineer, Biology, Biomedical Sciences, Project Management
• 2 years of experience in regional clinical study leadership (field experience) would be a definite advantage
• Knowledge of French an asset
• In-country CRA / monitoring/ sites experience an asset

Why GSK?

We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.

Find out more:

Our approach to R&D.   

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re 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.

GSK is an equal opportunity employer committed to diversity and inclusion.  We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com.  Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

As a health and science-based organization, GSK is committed to following the recommendations as set out by Health Canada and taking all necessary steps to help curb the spread of COVID-19 which includes getting the COVID-19 vaccine. We feel strongly that this is the best way to help protect those we value most: our employees, families, communities and the patients and consumers we serve. To that end, we are taking an important step to ensure the safety of our employees during this global public health crisis.

Only employees who are fully vaccinated against COVID-19 may attend our Mississauga and Laval corporate offices. In addition, all customer-facing employees who, as part of their job, attend healthcare settings such as hospitals, pharmacies, doctors’ offices and dentists’ offices will need to be fully vaccinated against COVID-19.  Notwithstanding the foregoing, employees may seek an accommodation for human rights-related reasons, including medical or disability-related conditions, or religious beliefs.

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