US or Canadian based - Remote Position
Are you energized by the opportunity to partner with key leaders in global medical science to enhance global operational support? If so, this Study Delivery Lead could be an exciting opportunity to explore.
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.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following
Why you? Basic Qualifications:
- 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.
We are looking for professionals with these required skills to achieve our goals:
- 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
If you have the following characteristics, it would be a plus:
- Master, Post graduate degree in a life science field (Pharmacy, Chemistry, Bio Engineer, Biology, Biomedical Sciences, Project Management
- Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
- 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
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges 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 geneticsscience; 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 diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas 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 culturethat isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership ofgoals and support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together. *LI-GSK
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