TFS HealthScience is excited to be expanding our SRS team and we are looking for an experienced, highly motivated Evidence Delivery Director who shares our vision of providing clinical research excellence. Our SRS team is a highly experienced international group of professionals led by an industry expert. We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.
Our core values of Trust, Quality, Flexibility, Passion, and Sustainability are what makes TFS HealthScience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization. Together we make a difference. TFS HealthScience is looking for an Evidence Delivery Director in Barcelona.
What can we offer you?A great place to work where you will get the chance to push your career to the next level, a global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients. Spain benefits include:
Private Health CoverageGlobal General Liability InsuranceGlobal Travel InsuranceHomebased Allowance for home-based employeesLunch AllowanceFlexible working scheduleResponsibilitiesCross-functional collaboration and stakeholder management to drive operationally viable outcomesOperational delivery input on feasibility of a proposed study or projectContribute to Governance reviews of global studies (also including local studies upon agreement EDGD) and other relevant forums as required (e.g. GPT, JPT, etc.)Support the development of one-pagers in close collaboration with Payer & Strategy LeadsProcess improvements, e.g. RFP process, ballparking, feasibility, etc.Mentoring, sharing of lessons learned, best practices, problem solvingEarly engagement with CRO partners and RFP processResponsible to provide insights on operational feasibility during the SDC development processDrive the process of coordinating protocol development by ensuring input of all relevant cross-functional (internal) and external stakeholdersResponsible to provide input on operational feasibility of the protocolCore member of ERT and other planning/life cycle meetings, representing Evidence Delivery to provide operational expertise into Study Design Concepts and Study ProtocolsPlan & ensure adherence to all internal, study governance processes (e.g. ERT, MARC)Lead the process for selection of External Service Providers (ESPs), including Clinical Research Organizations (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 limitsManage study-specific issues and escalations with ESPs/CROsSet up study team and manage study resourcingEffective collaboration with the scientific/medical counterpart, the Epidemiologist/Global Medical Affairs Leader (GMAL)/TA Medical Head respectively, as well as other internal cross-functional global rolesReport study updates from a time, cost and quality perspective to internal stakeholders and also Joint Product Team (JPT) meetingsClarify and document an effective communication approach, as well as roles and responsibilities between the BPM Evidence stakeholders, local AZ and External Service ProvidersEnsure appropriate level of involvement of the external scientific community (e.g. (Inter)national Coordinating Investigators, Steering/Executive Committee) during study design and deliveryDevelop and maintain the overall study budget (internal and external study costs)Keep transparency on study budget and changes through relevant systems (such as ACCORD) and platforms (Planning Performance and Control (PPC) meetings) and obtain approval for budget changesWork with procurement on study agreement and manage subsequent out of scope changes for ESP/CROManage and reconcile Contracts, POs and invoicesFinancial audit readiness and Sox attestationKey player in process improvements across Global Evidence DeliveryDeliver studies to agreed timelines (scorecard), within the approved budget and according to client quality standardsEnsure global oversight over the operational study start-up, implementation and closure and ensure inspection readinessLead study-related change management within business strategy, such as assessment of scope changesEnsure Compliance with client Procedural Documents, Standards and Policies, international guidelines#J-18808-Ljbffr