Study Delivery Lead

仕事内容

Site Name: Belgium-Wavre

Posted Date: May 18 2022

Job Purpose

• The Study Delivery Lead (SDL) is the Project Manager of a study. As such, you are 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.
• You are 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.
• You coordinate other functions (clinical and non-clinical) at study level.
• You work 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.
• In order to maintain the right expertise and provide the best support, there will be dedicated SDLs for most of the clinical and epidemiology/supported studies.
• Within the Clinical Evidence Generation Platform, you support process improvements and participates in working groups as applicable.
• You interact with other SDLs to share best practices, lessons learned and support process improvement with participation in working groups as applicable.
• For studies of greater complexity, several SDLs can be appointed to support a senior SDL in the delivery of the study.
  

Your Responsibilities

• The SDL is ensuring 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:
• You develop a study management plan including forecast, detailed schedule, budget and Quality Management Plan.
• You ensure a study-level risk assessment is performed, ensures that identified risks are appropriately mitigated. The SDL develops and maintains Study Risks Management Plan.
• You ensure 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 o The SDL prepares monitoring and communication plans (including definition of study essential data for adaptive monitoring).
• You ensure issue escalation and management up to resolution. The SDL communicates progress and escalates issues to the Project Delivery Lead when appropriate.
• You define resource requirements and ensure appropriate resourcing (including outsourcing).
• You track delivery to time, cost and quality, ensures maintenance of standard tools such as iPlan, eTrack and SAP.
• You set 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.
• You is accountable for the study budget May 31st, 2019 Page 2 of 5 o The SDL 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...
• The SDL, 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.
• You lead 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.
• You ensure 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.
• You develop and maintain, with the Study Core team, the study dashboard including key risk indicators (KRIs), key performance indicators (KPIs) and other study related reports / tools.
• You communicate progress to Project Delivery Lead and study team.
• You lead and oversee operational activities in study design and study execution including:
• Inputs to concept protocol and protocol development to ensure optimal operational design
• You are 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.
• You are 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.
• You ensure functional strategy and plans are developed, maintained and executed including clinical supplies, sample management, data management, document management and quality. Each study core team member keeps his own accountability to ensure planning and execution of his departmental plans.
• You participate in country and site selection, with reference to pre-selection decisions made at Development Plans level.
• You, in coordination with the study core team, ensure that appropriate documents are available to regional teams for timely submission to Ethics Committees and/or Regulatory Authorities according to local requirements.
• You ensure appropriate training of country staff and sites on protocol and project specific matters - Prepare/deliver monitors meeting (when applicable).
• You develop and ensure on-time execution of supportive documents, plans and manuals including the monitoring plan, study procedures manuals, core operational packages for submission and for countries.
• You are responsible for vendor management activities including selection and contract development when outsourced activities are owned by the SDL.
• You develop and follow 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).
• You provide input to the clinical study report / module appendix.
• You ensure Sign-off essential study documents.
• You ensure collection and review of Protocol deviations and ensure review & analysis of Data Quality Escalate as appropriate.
• You are typically responsible for 1-4 trials of average design and protocol complexity (can be more for Supported or very simple studies).
• You maintain 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

We are looking for professionals with these required skills to achieve our goals:

• Master ’s degree (General Science or Life/Health related Science Degree) or equivalent with 6 years of significant 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.
• Applies industry best practices to the design and execution of clinical studies to improve time and cost efficiency.
• Acts as role model in line with GSK Vaccines core values and Expectations.
• Able 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. Knowledge of French an asset.
• In-country CRA / monitoring/ sites experience an asset.
  

Preferred Qualifications

Ifyou have the following characteristics it would be a plus:

• Post graduate degree in a life science field desirable
• 2 years of experience in regional clinical study leadership desirable
• Li-GSK
  

Why GSK?

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.

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.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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