Global Study Leader


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

16th September 2021

Location

Cambridge

Salary/Rate

Upto £625

Type

Contract

This job has now expired please search on the home page to find live IT Jobs.

The Global Study Leader will either be asked to LEAD or SUPPORT the named Study leader in the overall leadership/project management of major components of the overall effort.Specific activities/responsibilities per type of study: The candidate will be asked to lead overall delivery OR substantial components of the overall delivery effort for 1-2 multi-disciplinary multi-national interventional (or primary observational) studies. The global study teams will participants from the external 'preferred partner' CRO chosen to deliver the study in the Oncology arena. They will be held accountable for leading this team in successfully executing the planning, delivery and reporting of one/more oncology studies or or partnering with the study team leader in leading a substantial component of the overall effort. These studies will either be interventional (80%) or primary observational (20%) in nature.They will have overall responsibility for the Project Management of the studies (indirectly reporting to a Programme Director from a Therapy Area perspective)· Deliver studies to agreed timelines (scorecard), within the approved budget and according to quality standards.· Ensure global oversight over the operational study start up, implementation and closure and ensure inspection readiness· Lead study related change management within business strategy, s.a. assessment of scope changes.· Ensure Compliance with Procedural Documents, Standards and Policies, international guidelines and local regulations at any time, and report compliance breaches· Undertake feasibility assessments with internal and external stakeholders· Manage study system reporting· Lead the study and manage the study team stakeholders (e.g. core team, extended team, delivery team· They will manage Study Governance (post SDC) · Coordinate all internal, study governance processes· External Service Provider Management· Lead the process for selection of External Service Providers (ESPs), including Clinical Research Organisations (CROs)· Collaborate with CRO/ESP to ensure the study operational aspects are effectively undertaken and ensure that study delivery is within time, cost and quality limits· Manage study specific issues and escalations with ESPs/CROs.They will be responsible for Stakeholder Management throughout study delivery· Set up study team and manage study sourcing· Effective collaboration with the scientific/medical counterpart, the Epidemiologist/Medical Affairs Leader (MAL) respectively, as well as other internal cross functional global roles· Report study updates from a time, cost and quality perspective to internal stakeholders (e.g. Evidence Program Director (EPD)· Clarify and document an effective communication approach, as well as roles and responsibilities between the MEOR stakeholders, local and External Service Providers.· Ensure appropriate level of involvement of the external scientific community (e.g. (Inter)national Coordinating Investigators, Steering/Executive Committee) during study design and deliveryThey will manage study financial tracking and spend management:· Develop and maintain the overall study budget (internal and external study costs)· Keep transparency on study budget and changes through relevant systems and platforms (Planning Performance and Control (PPC) meetings and obtain approval for budget changes· Work with procurement on study agreement and manage subsequent out of scope changes for ESP/CRO· Manage and reconcile Contracts, POs and invoices· Financial audit readiness and Sox attestationHave input into Study Design Concept (SDC) as it is being generated by the Programme Director and programme level experts · Responsible to provide the insights on operational feasibility during the SDC development process.· They will be accountable for the delivery of the protocol (although the document itself will be authored by the CRO deployed to the study). As such they will a) drive the process of coordinating protocol development by ensuring input of all relevant cross functional (internal) and external stakeholders and b) be responsible to provide input on operational feasibility of the protocolPlease click here to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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