Evidence Delivery Manager


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

23rd August 2021

Location

Cambridge

Salary/Rate

Upto £600

Type

Contract

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

The Evidence Delivery Manager 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. The EDM will be held accountable by the company for leading this team in successfully executing the planning, delivery and reporting of one/more oncology studies 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.· Deliver studies to agreed timelines (scorecard), within the approved budget and according to the companies 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 the companies 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 teamThey will manage Study Governance (post SDC) from the companies perspective· Coordinate all internal, study governance processes· External Service Provider Management· Collaborate with CRO/ESP to ensure the study operational aspects are effectively undertaken and ensure that study delivery is within time, cost and quality limitsThey will be responsible for Stakeholder Management throughout study delivery· 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 within the company.· Responsible to provide the insights on operational feasibility during the SDC development process.· They will be accountable for the delivery of the protocol

What are the essential skills and experience?All candidates MUST have the below:· At least 3 years hand-on experience leading a multi-disciplinary, multi-national study team responsible for the delivery of all aspects of at least one multi-national, multi-site clinical (or evidence generating) global interventional study· At least 6 years hands-on experience in the delivery or global clinical or medical evidence generation interventional studies activities in (which may include project managing multiple countries or a region with multiple participating sites and monitoring of those sites)· At least 2 years experience leading in the Oncology Therapy area, ideally in a project managerial roles looking after multi-national clinical trials or evidence generation trials.· At least 2 years experience leading a global interventional study or leading/project managing a substantial component of overall study delivery in a fully outsourced setting with a track record of overseeing an external service provider and holding them to account for delivery.· Very good knowledge of the aspects of the Clinical Study Delivery process, international ICH/GCP guidelines and the Drug Development industry.

What are the desirable skills?Ideally they will have:· Professional project management accreditation (e.g. PMP, APMP, PRINCE 2 Practitioner) but this is an ideal· Previous experience working with studies aimed at generating evidence (ie Phase IIIb/Phase IV studies) Please 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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