Evidence Delivery Director

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 midsize Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the fullservice capabilities and global reach of a large CRO with the flexibility and personal approach only a midsize CRO can deliver.

Our cores 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 organisation.

Together we make a difference.

TFS HealthScience is looking for an Evidence Delivery Director in Barcelona.

We look forward to receiving your application soon!

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 Coverage
• Global General Liability Insurance
• Global Travel Insurance
• Homebased Allowance for homebased employees
• Lunch Allowance
• Flexible working schedule

Responsibilities

• Cross functional collaboration and stakeholder management to drive operationally viableoutcomes
• Operational delivery input on feasibility of a proposed study or project
• Contribute to Governance reviews of global studies (also including local studies upon agreementEDGD) and other relevant forums as required (e.g. GPT JPT etc...)
• Support the development of onepagers in close collaboration with Payer & Strategy Leads
• Process improvements e.g. RFP process ballparking feasibility etc
• Mentoring sharing of lessons learnt best practices problem solving
• Early engagement with CRO partners and RFP process
• Responsible to provide the insights on operational feasibility during the SDC development process.
• Drive the process of coordinating protocol development by ensuring input of all relevant cross functional (internal) and external stakeholders
• Responsible to provide input on operational feasibility of the protocol
• Core member of ERT and other planning/life cycle meetings representing Evidence Delivery to provide operational expertise into Study Design Concepts and Study Protocols
• Plan & 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 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
• Set up study team and manage study resourcing
• Effective 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 roles
• Report study updates from a time cost and quality perspective to internal stakeholders and also Joint Product Team (JPT) meetings.
• Clarify and document an effective communication approach as well as roles and responsibilities between the BPM Evidence stakeholders local AZ 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 delivery
• Develop 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 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 attestation
• Key player in process improvements across Global Evidence Delivery
• Deliver studies to agreed timelines (scorecard) within the approved budget and according to client 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 such as assessment of scope changes.
• Ensure Compliance with client 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 Externally Sponsored
• Responsible for leading the review and evaluation of all ESR proposals and protocols in line with a products scientific strategy within the assigned area
• Ensure operational compliance with policies and procedures for ESRs globally
• Responsible for implementation of ESR quality framework within a TA
• Ensure development of compound ESR strategy within assigned TA including its dissemination integration and execution within the ESR framework
• Responsible for reporting and communication of ESR metrics and KPIs within the assigned area including but not limited to ESR portfolio performance and ESR outcomes including final results publications and overall impact
• Early engagement with GMALs Medical Heads and Evidence Leads ensuring visibility of the ESR portfolio and opportunities
• Manage across a range of global and local crossfunctional stakeholders to ensure all AZ obligations and responsibilities for ESR (e.g. drug supply contracting regulatory documentation publication review etc.) are met
• Manage external stakeholder e.g. external Investigator and Sponsoring institutions Lead ESR portfolio financial forecasting and budgeting for assigned ESR studies/portfolios utilising appropriate Company systems to facilitate awareness and understanding of ESR budget commitments (e.g. forecast versus actuals)
• Provide oversight to local Marketing Companies (MCs) to ensure all operational delivery aspects of ESR are achieved within agreed timelines and budgets to expected levels of quality and in line with the legal and compliance requirements escalating issues around nonattainment of performance metrics as appropriate
• Lead and manage the delivery of complex multiproduct/country/cross regional collaborative ESR studies. Coordinates complex ESR in conjunction with MCs overseeing Medical Affairs specialists and/or study management specialists to ensure compliance with project management guidelines external regulations and internal processes/policies to enable high quality research
• Acts as the first point of contact for local MC operational enquiries
• Tracks all ESR study time cost and quality KPIs taking corrective action as required. In doing so guides the MC in the changing of ESR study milestones and finances in light of changing needs and requirements to ensure that deliverables continue to be efficiently and effectively met
• Lead the planning implementation and delivery of EA programmes
• Collaborate with vendors to ensure the EA Program operational aspects are effectively undertaken and that they have clear remits for delivery to ensure EA Program is on time on budget and of high quality.
• Manage the resolution of program specific issues and escalations with internal (e.g. Global Clinical Leads Chief Medical Office supply chain representatives) and external stakeholders
• Lead the operational governance of the EAP vendor and represent the TA and/or function in strategic alliance contracting and partnership to ensure effective collaboration and compliance across the enterprise
• Early engagement with R&D and Medical ensuring visibility of the EAP portfolio and opportunities
  

Requirements

• Bachelors degree required preferably in medical or biologicalscience or equivalent by experience.
• Extensive pharmaceutical industry/CRO experience within clinicalstudy/research project delivery drug development process andrelevant guidelines for example GCP/ICH for a specific therapeuticand geographical area.
• Project Management qualification or demonstration of projectmanagement skills including scope budget timeline resourcemanagement and use of associated tools.
• Scientific awareness and extensive knowledge of observationalstudy guidelines and SOPs
• Extensive knowledge of early and late stage PharmaceuticalDevelopment
• Ability to effectively work with Clinical ResearchOrganisations/External Providers.
• Proven ability to interact widely and effectively within the companyacross regions functions and cultures.
• Experience and knowledge within compliant management ofExternally Sponsored Scientific Research
• Persuasive communicator in English with a proven ability to work
• collaboratively in a multicultural environment
• Open to periods of travel

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TFS HealthScience does not discriminate on the basis of race sex color religion age national origin marital status disability veteran status genetic information sexual orientation gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.